CHAPTER Ph
100 ORGANIZATIONAL RULES
PART Ph 101 PURPOSE AND SCOPE
Ph 101.01 Purpose and Scope. The rules of this title implement the
statutory responsibilities of the
Source.
#1856, eff 11-9-81; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-A,
eff 2-5-96
PART Ph 102 DEFINITIONS
Ph 102.01 Statutory Definitions Adopted. All terms used in these rules shall have the
same meaning as in RSA 318:1, RSA 318-B:1 and RSA 541-A:1.
Source.
#1639, eff 11-1-80; amd by #1856, eff 11-9-81;
ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss
by #6094-A, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-A,
eff 2-5-96
Ph 102.02 Other Definitions.
(a)
"Board" means the
(b)
"Evidence" means all oral or documentary material received by
the board. Evidence includes, but is not
limited to, testimony under oath or affirmation, documents, exhibits, and sworn
statements of witnesses who are unable to appear at the proceedings.
(c)
"Executive secretary" means the board's staff director, a
person with delegated authority to perform administrative and clerical
functions for the board.
(d)
"Licensed" means a person or place lawfully authorized to
engage in the practice of pharmacy under RSA 318:18 and RSA 318:37 and includes
''registered'' when used to refer to pharmacists or pharmacies.
(e)
"Order" means the whole or any part of the final decision,
whether affirmative, negative or declaratory in form, of the board in any matter
other than rulemaking, but including licensing.
An order has particularized effect on each party to the proceeding.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-A,
eff 2-5-96
PART Ph 103 AGENCY ORGANIZATION
Ph 103.01 Composition. The
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-A, eff 2-5-96, EXPIRED 8-8-10 pursuant
to RSA 541-A:17, II
New. #10117, eff 4-20-12
Ph 103.02 Officers. Annually, in September, the board members
shall elect, from among their number, a president, a vice president, a
secretary and a treasurer.
Source.
#6181-A, eff 2-5-96
Ph 103.03 Address.
(a)
The board shall maintain an office at 7 Eagle Square, Concord, N.H.
03301. All correspondence with the board
shall be addressed as follows:
State of
7 Eagle Square
Concord, New
Hampshire 03301.
(b)
The telephone number of the board shall be (603) 271-2152. The fax number shall be (603) 271-2856.
Source.
#6181-A, eff 2-5-96
Ph 103.04 Meetings.
(a)
The board shall meet in its office on the third Wednesday of each
month. Special meetings shall be held at
the call of the president or by any officer.
(b)
A majority of the board may take action by telephone poll or written
ballot provided that such action is ratified at a subsequent meeting of the
board.
Source.
#6181-A, eff 2-5-96
PART Ph 104 PUBLIC INFORMATION
Ph 104.01 Records. Except as exempted by law, all records of the
board may be examined by any person at the board office, during weekdays,
excluding holidays, from 8:00 a.m. to 4:00 p.m.
Source.
#6181-A, eff
2-5-96
Ph 104.02 Copies.
(a)
At the time and place identified in Ph 104.01, any person examining a
document may make a copy of that document by any means not injurious to the
document provided that the person wishing to make the copy supplies the means
of doing so in the office of the board.
In the event a person does not have a means of copying those documents,
the board shall make copies of the documents examined upon request.
(b)
The prescribed fee for copies of documents made by this board shall be a
minimum of $5.00 which includes up to 20 pages then 0.25¢ for each additional
page thereafter and shall be payable in advance by bank draft, money order,
certified check or cash.
Source.
#6181-A, eff
2-5-96
Ph 104.03 Lists of Licensees/Registrants.
(a)
Instead of the examination and copying permitted by Ph 104.01 and Ph
104.02, any person may request the board to provide that person with a complete
mailing list of the board’s
licensees/registrants. This request
shall be accompanied by the prescribed fee for each list requested and shall be
paid by check or money order.
(b)
The fees for the lists shall be:
(1) Pharmacist data file by e-mail $125.
(2) Pharmacist data file on CD-ROM $150.
(3) Pharmacist pre-printed mailing labels $200.
(4) Pharmacy Technician data file by e-mail $125.
(5) Pharmacy Technician data file on CD-ROM $150.
(6) Pharmacy Technician pre-printed mailing labels $200.
(7) In-State Pharmacy data file by e-mail $
75.
(8) In-State Pharmacy data file on CD-ROM $100.
(9) In-State Pharmacy pre-printed mailing labels $150.
(10) Out-of-State Pharmacy data file by e-mail $ 75.
(11) Out-of-State Pharmacy data file on CD-ROM $100.
(12) Out-of-State Pharmacy pre-printed mailing
labels $150.
(13) Drug Manufacturer/Wholesaler data file by
e-mail $
75.
(14) Drug Manufacturer/Wholesaler data file on
CD-ROM $100.
(15) Drug Manufacturer/Wholesaler pre-printed
mailing labels $150.
Source.
#6181-A, eff 2-5-96; ss by #9139-A, eff 4-25-08
CHAPTER Ph
200 PRACTICE AND PROCEDURE
PART Ph 201 INTRODUCTION AND DEFINITIONS
Ph 201.01 Procedure Governed. This chapter governs practice and procedure
before the board in both adjudicative and non-adjudicative proceedings.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A, eff 3-26-05
Ph 201.02 Definitions.
(a)
"Adjudicative proceeding" means the procedure to be followed
in contested cases, as set forth in RSA 541-A:31 through RSA 541-A:36.
(b)
"Board" means the
(c)
"Declaratory ruling" means a ruling by the board as to the
specific applicability of any statutory provision or of any rule or order of
the board.
(d)
"Licensee" means a person, partnership, corporation, or any
other legal or commercial entity however organized, duly licensed by the board
pursuant to the provisions of RSA 318, RSA 318-B, or other applicable law.
(e)
"Opponent" means any person who objects, on the grounds of
public or private interest, to the approval, determination, consent,
certification or authorization of any petition which the board might have under
consideration.
(f)
"Party" means each person named or admitted as a party, or
properly seeking and entitled as a right to be admitted as a party in an
adjudicative proceeding.
(g)
"Presiding officer" means the board president or an individual
to whom the board president has delegated the authority to preside over an
adjudicative proceeding, a rehearing, or a rulemaking hearing.
(h)
"Proponent" means any person who supports, on the grounds of
public or private interest, the approval, determination, consent, certification
or authorization of any petition which the board may have under consideration.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
PART Ph 202 FILING AND SERVICE OF DOCUMENTS
Ph 202.01 Filing of Documents.
(a)
A document shall be considered filed when it is actually received at the
board's office in
(b)
All documents filed shall be either originals or legible copies bearing
original signatures. Only a single copy
of routine correspondence, license applications, and consumer complaints
against licensees shall be filed.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82;
ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss
by #6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 202.02 Subscription and Veracity of Documents.
(a)
All complaints, petitions, motions, and replies filed with the board
shall be signed by the proponent of the document or, if the party appears by a
representative, by the representative.
(b)
The signature on a document filed with the board shall constitute a
certification that:
(1) The signor has read the document;
(2) The signor is authorized to file it;
(3) To the best of the signor's knowledge, information,
and belief, there are good grounds to support it; and
(4) The document has not been filed for purposes
of delay or harassment.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 202.03 Service of Documents.
(a)
Complaints against licensees of the board shall be filed with the board
without service upon the licensee which is the subject of the complaint.
(b)
Petitions for rulemaking and petitions for declaratory rulings shall be
filed with the board without service upon other persons.
(c)
All motions, replies, exhibits, memoranda, or other documents filed in
an adjudicatory proceeding shall be served by the proponent upon all parties to
the proceeding by:
(1) Sending a copy of the document by U.S. mail,
first class postage prepaid, addressed to the last address given to the board
by the party being served, no later than the day the document is filed with the
board; or
(2) Delivering a copy of the document in hand on or
before the date it is filed with the board.
(d)
All notices, orders, decisions or other documents issued by the board in
the course of an adjudicatory proceeding shall be served by the board upon all
parties to the proceeding by either:
(1) Sending a copy of the document by U.S. mail,
first class postage prepaid, addressed to the last address given to the board
by the party being served; or
(2) Delivering a copy of the document in hand to
the party.
(e)
When a party has appeared by a representative, service shall be upon the
representative.
(f)
Except for exhibits distributed at a prehearing conference or a hearing,
every document filed with the board and required to be served upon the parties
to an adjudicatory proceeding shall be accompanied by a certificate of service,
signed by the person making service, attesting to the method and date of
service, and the persons served.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 202.04 Voluntary Production of Information.
(a)
Each party and intervenor shall attempt in good faith to make complete
and timely response to requests for the voluntary production of information and
documents relevant to the hearing.
(b)
When a dispute arises concerning a request for the voluntary production
of information or documents, any party or intervenor may file a motion to
compel the production of the requested information or documents.
Source.
#8315-A, eff
3-26-05
Ph 202.05 Motions to Compel Production of
Information and Documents.
(a)
Any party or intervenor may make a motion seeking an order for
compliance with an information or document request. The motion shall be filed at least 20 days
before the date scheduled for the hearing and in any event as soon as possible
after receiving the notice of the hearing and failing in an attempt to obtain
the requested information or documents through voluntary production.
(b)
The motion to compel shall:
(1) Set forth in detail those facts which justify
the request for information or documents; and
(2) List with specificity the information or
documents being sought.
(c)
Objections to motion to compel shall be filed within 10 days of the
delivery of the motion.
(d)
The presiding officer shall grant the motion to compel if its proponent
has demonstrated that an order for compliance is necessary for a full and fair
presentation of evidence at the hearing.
Source.
#8315-A, eff
3-26-05
PART Ph 203 HEARINGS AND PROCEEDINGS
Ph 203.01 Mandatory Pre-Hearing Disclosure of
Witnesses and Exhibits. At least 5 days
before the hearing, the parties and intervenors shall provide to the other
parties and intervenors:
(a)
A list of witnesses intended to be called at the hearing including the
names, their addresses and their telephone numbers;
(b)
Brief summaries of the testimony of the witnesses to be called;
(c)
A list of documents and exhibits intended to be offered as evidence at
the hearing;
(d)
A copy of each document intended to be offered as evidence at the
hearing; and
(e)
An offer to allow the inspection on non-documentary exhibits intended to
be offered as evidence at the hearing at times and places of convenience to the
parties and intervenors.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.02 Representatives.
(a)
Any person may represent himself/herself in a proceeding before the
board or may be represented by an attorney or a competent individual of good
character.
(b)
A representative under (a) above shall be someone who:
(1) Is an attorney holding a current and active
New Hampshire license who has filed a written appearance with the board
containing his or her business address and telephone number; or
(2) Is not a
(c)
Motions made pursuant to Ph 203.01 (b)(2) shall:
(1) Describe the proposed representative's
qualifications including, but not limited to, the following:
a. Education;
b. Experience serving in a representative
capacity before administrative agencies, boards, or commissions; and
c. Present employment.
(2) Provide the proposed representative's daytime
address and telephone number; and
(3) Be signed by both the proposed representative
and the party who would be represented.
(d)
The board shall grant a motion made pursuant to Ph 203.01 (b) (2) if the
proposed representative does not have a history of dishonesty or felonious
acts.
(e)
Nothing in this section shall be construed to permit the unauthorized
practice of law.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B,
INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.03 Computation of Time. Any time period specified in this chapter shall
begin with the day following the act, event, or default, and shall include the
last day of the period, unless it is a Saturday, Sunday, or state legal
holiday, in which event the period shall run until the end of the next day
which is not a Saturday, Sunday, or state legal holiday. When the period prescribed or allowed is less
than 7 days, intermediate Saturdays, Sundays, and state legal holidays shall be
excluded from the computation.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.04 Change in Allowed Times.
(a)
Except where a time period is fixed by statute, a party may file a
motion to change a time period which shall set forth specific facts to support
their request to enlarge or shorten the time provided for the filing of any
document, or advance or postpone the time set for any oral hearing, prehearing
conference, or other activity.
(b)
The board shall grant such motion:
(1) If all parties consent; or
(2) For good cause shown from the facts
presented.
(c)
Good cause under (b) (2) above shall include the following:
(1) Unavoidable unavailability of witnesses,
parties, their attorneys, or their authorized representatives; or
(2) Other exigent circumstances beyond the
control of the parties, their attorneys, or their representatives.
(d)
A consent of the parties under (b)(1) above shall be:
(1) Made in writing;
(2) Signed by all parties; and
(3) Filed with the board prior to a scheduled
date or the expiration of a time period.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.05 Recess and Adjournment.
(a)
The presiding officer shall recess or adjourn any proceeding for good cause,
which shall include but not be limited to the following:
(1) Other exigent business of the board;
(2) The end of the business day; or
(3) Inclement weather.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89;
ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.06 Waiver.
(a)
Any interested person may request the board to waive or suspend
provisions of the Ph 200 rules by filing an original and 2 copies of a petition
which identifies the rule in question and sets forth specific facts and
arguments which support the requested waiver.
(b)
Petitions for rule waivers shall address whether:
(1) Adherence to the rule would cause the
petitioner hardship.
"Hardship" in this context means that because of petitioner's
unique circumstances strict adherence to a rule would be unreasonable or result
in unfair advantage to another party.
(2) Other good cause for waiving the rule exists,
including the following:
a. Repeal or amendment of the enabling statute for
provisions of rules from which a waiver is sought; or
b. Other circumstances which render a rule
inapplicable, unenforceable, or illegal.
(c)
If examination of the petition reveals that other persons would be
substantially affected by the proposed relief, the board shall require service
of the petition on such persons and advise them that they may file a reply to
the petition.
(d)
Petitions for waiver shall be acted upon by the board within 45 days of
receipt. The board shall give written
notice of the decision to all interested parties.
(e)
A granted waiver shall only apply to the proceedings under review at the
time of the petition.
(f)
Provisions of Ph 200 rules which include provisions of
(g)
A consent of the parties under (f) above shall:
(1) Be made in writing;
(2) Identify the specific rule provision to which
the waiver applies;
(3) Be signed by all parties; and
(4) Be filed with the board.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.07 Docket. The board shall maintain a docket of all
proceedings, hearings, and rehearings pending before the board.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.08 Consolidation.
(a)
A party may file a motion to consolidate whenever 2 or more proceedings
involve substantially similar or related issues.
(b)
A motion to consolidate may include a request for a single hearing, a
single decision, or both.
(c)
The board shall grant a motion to consolidate upon finding that:
(1) A requested consolidation would further the
interests of fairness and efficiency; and
(2) A requested consolidation would not impair
consideration of the issues presented by each individual matter.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 203.09 Severance.
(a)
A party may file a motion to sever one or more issues from a proceeding
and dispose of those issues in another proceeding whenever it shall appear that
injury to the substantive rights of a party or undue delay might be thereby
avoided.
(b)
The board shall grant a motion for severance upon finding that:
(1) A requested severance would further the
interests of fairness and efficiency; and
(2) A requested severance would not impair the proceeding
from which the issue or issues are removed.
Source.
#8315-A, eff
3-26-05
PART Ph 204 ADJUDICATIVE PROCEEDINGS
Ph 204.01 Applicability. This part shall govern adjudicative
proceedings before the board.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.02 Place of an Adjudicative Proceeding. Adjudicative proceedings before the board
shall be held at the offices of the board,
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.03 Commencement of Adjudicative Proceeding.
(a)
Pursuant to RSA 541-A:31, II, the board shall commence an adjudicative
proceeding at any time as a result of the following actions by a licensee:
(1) Failure to file requisite reports within 30
days of applicable deadlines;
(2) Failure to pay fees or fines within 60 days
of invoice date;
(3) Engaging in licensed activity with a
suspended, revoked, or expired license;
(4) Failure to allow board personnel access,
authorized by law, to the books, papers, records, files or similar documents
for purposes of conducting examinations; or
(5) Any other failure to comply with the laws, rules
or orders of the board governing the licensee's activities.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.04 Notice.
(a)
Notice of an adjudicative proceeding shall be governed by the following
provisions, unless otherwise provided by law:
(1) The board shall give written notice to a
party at least 30 days prior to a scheduled hearing date by first class mail,
postage prepaid, or by personal service upon a party or a party's agent;
(2) Contents of the notice shall be governed by
the provisions of RSA 541-A:31, III.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.05 Continuances.
(a)
Any party or intervenor may make an oral or written motion that a
hearing be delayed or continued to a later date or time.
(b)
A motion for a delay or a continuance shall be granted if the presiding
officer determines that a delay or continuance would assist in resolving the
case fairly.
(c)
If the later date, time and place are known when the hearing is being
delayed or continued, the information shall be stated on the record. If the later date, time and place are not
known at that time, the presiding officer shall as soon as practicable issue a
written scheduling order stating the date, time and place of the delayed or
continued hearing.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.06 Emergency Orders.
(a)
Pursuant to RSA 318:30-a, if the board finds that public welfare
requires emergency action against a licensee, and the board incorporates a
finding to that effect in an order, the board shall order the immediate
suspension of a license pending an adjudicative proceeding which shall be
commenced not later than 30 working days after the date of the board's
order suspending the license.
(b)
An emergency order shall be served upon the licensee by certified
mail-return receipt requested, or by personal service upon the licensee, or by
personal service upon the licensee's agent as identified on the most recent
license application submitted to the board.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.07 Intervention.
(a)
A person filing a complaint which becomes the subject of a disciplinary
hearing shall be served with the hearing notice and notified that he/she may
petition to intervene in the proceeding.
(b)
The board shall grant one or more petitions for intervention if:
(1) The petition is submitted in writing to the
board, with copies mailed to all parties named in the notice of hearing, at
least 3 days before the hearing;
(2) The petition states facts demonstrating that the
petitioner's rights, duties, privileges, immunities or other substantial
interests might be affected by the proceeding; and
(3) The interests of justice and the orderly and
prompt conduct of the proceedings would not be impaired by allowing the intervention.
(c)
Once granted leave to intervene, an intervenor shall enter the
proceeding as it stands at the time. No
portion of the proceeding shall be repeated because of the fact of intervention.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.08 Access to Board
Records.
(a)
Parties shall have access to any statements, documents, or other
information in the board's files pertinent to an adjudicative proceeding. However, confidential information pursuant to
RSA 318:30,I, including consumer complaints and confidential material otherwise
protected by law shall not be disclosed or provided to any party other than the
board.
(b)
The intervenor shall have access to all materials permitted by Ph 204.07
(a).
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.09 Filing Requirements. Copies of all documents, pleadings, motions,
objections, requests, memorandums, correspondence, accounts, and the like,
which are filed by a party with the board shall be provided to other parties to
the same proceeding as follows:
(a)
A party shall send copies of all documents filed by first class mail,
postage prepaid, to all other parties, or shall deliver such documents in hand
to all other parties; and
(b)
A party shall certify compliance with Ph 204.08 (a) by submitting a
certificate of service with the documents filed.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.10 Stipulations. The parties to an adjudicative proceeding may
by written stipulation agree upon facts or issues of proof relating to the
subject matter of the proceeding. The
stipulation shall be filed with the board and approved by the presiding officer
in order to be considered in rendering a decision.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.11 Evidence.
(a)
Proceedings shall not be conducted under the rules of evidence, but the
evidentiary privileges recognized by the law of
(b)
Pursuant to RSA 541‑A:33, II, the board shall receive all material
and relevant evidence bearing upon the subject matter of the proceeding.
(c)
The presiding officer shall determine the admissibility of evidence and
shall exclude irrelevant, immaterial or unduly repetitious evidence.
(d)
All witnesses appearing before the board shall testify under oath or
affirmation and subject to the penalties specified in RSA 641:1 and RSA 641:2.
(e)
Oaths or affirmations shall be administered by the presiding officer.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.12 Withdrawal of Presiding Officer.
(a)
Upon his or her own initiative or upon the motion of any party or
intervenor, the presiding officer shall withdraw from any adjudicative
proceeding for good cause.
(b)
Good cause shall exist if the presiding officer:
(1) Has a direct interest in the outcome of the
matter, including but not limited to, a financial or family relationship with
any party or intervenor;
(2) Has made statements or engaged in behavior
which objectively demonstrates that he or she had prejudged the facts of the
case; or
(3) Personally believes that he or she cannot
fairly judge the facts of the case.
(c)
Mere knowledge of the issues or acquaintance with any party, intervenor
or witness shall not constitute good cause for withdrawal.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.13 Hearing Procedure.
(a)
After calling the hearing to order, the presiding officer shall identify
the proceeding for the record by name and docket number, shall briefly state the
nature of the proceeding, and shall request those present to identify
themselves for the record.
(b)
The presiding officer shall afford an opportunity for opening statements
or direct testimony by the board representative and the licensee or licensee's
representative.
(c)
After any opening statements, the board representative shall present
witnesses and exhibits, followed by presentation of witnesses and exhibits by
the licensee or licensee's representative.
(d)
(e)
The presiding officer shall if additional information is required pose
questions to any witness during or subsequent to direct testimony or
cross-examination.
(f)
After all testimony and evidence is presented, the presiding officer
shall allow closing statements by the board representative and by the licensee
or licensee's representative.
(g)
After all information has been presented, the presiding officer shall
declare the hearing closed.
(h)
The presiding officer shall afford intervenors the same opportunities
for presenting testimony, evidence, or witnesses, and for conducting cross‑examinations
and for making closing statements as other parties to the proceeding.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.14 Burden of Proof.
(a)
The party asserting the affirmative of a proposition shall have the
burden of proving the truth of that proposition by a preponderance of the
evidence.
(b)
Without limiting the generality of Ph 204.12 (a), all moving parties and
all petitioners shall have the burden to show that their motion or petition
should be granted.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by #2260, eff 1-5-83; ss by
#2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED:
1-19-96;
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.15 Decisions.
(a)
If the board finds that the licensee has complied with the statutory
requirements and the rules adopted pursuant thereto, the board shall enter a
decision favorable to the licensee.
(b)
If the board finds that the licensee has not complied with the statutory
requirements or any rule adopted pursuant thereto, the board shall enter a
decision adverse to the licensee.
(c)
The board's decision shall be set forth in writing.
(d)
The decision shall include findings of fact and conclusions of law,
separately stated.
(e)
If any party has submitted proposed findings of fact, the board's
decision shall include a ruling on each proposed finding.
(f)
The board shall give written notice of decisions to parties within 7
days after the date of decision by first class mail, postage prepaid.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 204.16 Failure to Appear.
(a)
Failure of a licensee to appear in person or by representative at the
adjudicative proceeding shall constitute a default.
(b)
A default for failure to appear shall constitute:
(1) A waiver of licensee's right to an
adjudicative proceeding;
(2) Admission of the facts alleged; and
(3) Consent to the board's determination on the
matter.
(c)
The board shall strike a default for failure to appear based upon a
written request and information submitted by the licensee within 7 days after
the originally scheduled hearing date which sets forth good cause. Good cause shall include illness, accident,
the death of family member, or other circumstances beyond the control of the
licensee.
(d)
The board shall give written notice to parties of a decision either to
grant or deny a request to strike a default for failure to appear within 7 days
of the date of decision by first class mail, postage prepaid.
(e)
If a request to strike a default for failure to appear is granted, the
board shall give notice of a re-scheduled hearing in accordance with Ph 204.04.
Source.
#8315-A, eff
3-26-05
Ph 204.17 Informal Settlement.
(a)
Any informal settlement of matters by nonadjudicative processes shall be
reflected in writing and made part of the record for a particular matter.
Source.
#8315-A, eff
3-26-05
PART Ph 205 REHEARINGS AND APPEALS
Ph 205.01 Motion for Rehearing.
(a)
A motion for rehearing shall be considered only after a decision or
order has been made by the board.
(b)
Any party to the proceeding may apply for a rehearing in respect to any
matter determined in the action or proceeding, or covered or included in the
order.
(c)
Motions for rehearing shall be filed with the board within 30 days of
the date of the final decision or order.
(d)
Motions for rehearing shall set forth fully every ground upon which it
is claimed that the decision or order complained of is unlawful or
unreasonable, or based upon a mistake of law or fact.
(e)
A party may submit a memorandum of law in support of a motion for
rehearing.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 205.02 Action on Motion for Rehearing.
(a)
Pursuant to RSA 541:5, within 10 days of receiving a motion for
rehearing, the board shall render a decision either to grant or deny the
motion, or suspend the order or decision complained of pending further
consideration.
(b)
Pursuant to RSA 541:3, the board shall grant such motion if good reason
for the rehearing is provided.
(c)
Good reason shall include, but not be limited to, the following:
(1) New information which was not available at
the time of hearing;
(2) A change in law relied upon by the board in
reaching a decision on the hearing, including amendment or repeal of statutes
or administrative rules, and changes in common law based upon decisions of the
supreme court; or
(3) Other factors beyond the control of the
moving party causing the decision to be unreasonable or unlawful, or to be
based upon a mistake of law or fact.
(d)
The board shall give written notice of decision on a motion for
rehearing to the parties within 7 days after the date of decision by first
class mail, postage prepaid.
(e)
If a motion for rehearing is granted, the board shall give written notice
to the parties at least 30 days prior to the scheduled rehearing date by first
class mail, postage prepaid, or by personal service.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 205.03 Burden of Proof. The burden of proof shall be on the moving
party to show by preponderance of the evidence that the board's decision was
unlawful or unreasonable, or was based upon a mistake of law or fact.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 205.04 Decisions.
(a)
The board shall issue a written decision within 20 days of the date of
the rehearing which clearly states the reasons for the decision.
(b)
The decision shall include information on the rights of appeal to the
supreme court pursuant to RSA 541, if the decision is adverse to the party who
appeals.
(c)
The board shall keep a final decision in its records for at least 5
years following their dates of issuance, unless the director of the division of
records management and archives of the department of state sets a different
retention period pursuant to rules adopted under RSA 5:40.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
PART Ph 206 DECLARATORY RULINGS
Ph 206.01 Petitions.
(a)
A person may request a declaratory ruling from the board on matters
within its jurisdiction by filing an original and 2 copies of a petition with
the board.
(b)
All petitions shall contain the following information:
(1) The name and address of the petitioner;
(2) The name and address of the petitioner's
representative, if any;
(3) A statement of the issue or question for
which the petitioner seeks a declaratory ruling;
(4) A statement of all relevant and material facts
related to the petitioner's request; and
(5) The identification of any statutes, rules,
orders, or other legal authority which support the petitioner's request.
(c)
A petition for a declaratory ruling may include the following:
(1) Legal memoranda, supporting affidavits,
tables, exhibits, and other relevant documentation; and
(2) A statement explaining how the requested
ruling would benefit the petitioner or the public at large.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 206.02 Action on Petition.
(a)
Within 90 days of the receipt of the petition for a declaratory ruling,
the board shall:
(1) Respond to the petitioner in writing, stating
the board's declaratory ruling on the issues or questions raised in the
petition; and
(2) File the declaratory ruling with the director
of legislative services in accordance with RSA 541-A:16, II (b).
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
PART Ph 207 RULEMAKING PETITIONS
Ph 207.01 Rulemaking Petitions.
(a)
A person may request the adoption, amendment, or repeal of a board rule
by filing an original and 2 copies of a rulemaking petition with the board.
(b)
A rulemaking petition filed with the board shall include the following:
(1) The name and address of the petitioner;
(2) The name and address of the petitioner's
representative, if any;
(3) A statement of the justification for the
adoption, amendment, or repeal of a rule;
(4) Any supporting data, information, exhibits,
illustrations, or other documentation;
(5) The identification of any statutes, rules,
orders, or other legal authority which support the petition; and
(6) A draft of the proposed rule.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 207.02 Incomplete Rulemaking Petitions.
(a)
The board shall notify the petitioner of deficiencies in the petition
within 15 days of the submission of a petition to adopt, amend, or repeal a
rule.
(b)
Any corrected petition which is filed with the board shall be deemed to
be the first submission of the petition for the purposes of applicable
deadlines.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 207.03 Action on Rulemaking Petition.
(a)
Within 30 days after the submission of a rulemaking petition, the board
shall either grant or deny the petition and:
(1) Notify the petitioner in writing of a
decision to deny the petition with reasons for the denial clearly stated; or
(2) Notify the petitioner in writing of a
decision to grant the petition, and commence rulemaking proceedings by
requesting a fiscal impact statement pursuant to RSA 541-A:5 within 120 days of
receipt of the petition and continuing the proceeding in accordance with the
applicable provisions of RSA 541-A:3.
(b)
Any denial shall be based upon a finding by the board that:
(1) The petition for rule or amendment or repeal
of an existing rule would not be consistent with established standards for the
practice of pharmacy and the licensees of the board;
(2) The petition lacks rulemaking authority; or
(3) The petition is contrary to legislative
intent.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
PART Ph 208 RULEMAKING HEARINGS
Ph 208.01 Public Notice of Rulemaking Hearing. The board shall cause to be published in the
New Hampshire Rulemaking Register a notice of its intent to conduct a
rulemaking hearing pursuant to RSA 541-A:6.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 208.02 Presiding Officer.
(a)
The presiding officer shall:
(1) Maintain order during the rulemaking hearing,
and order any person causing disorder or a disruption to the orderly conduct of
the hearing to leave the hearing room;
(2) Recognize speakers who have placed their
names on the speakers list;
(3) Receive all written comment that is submitted
during the course of a hearing; and
(4) Adjourn the hearing.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 208.03 Order of the Rulemaking Hearing. The hearing shall proceed as follows:
(a)
The presiding officer shall make opening remarks;
(b)
Proponents of the adoption, amendment or repeal of the rule shall be
called by the presiding officer to provide comment;
(c)
Opponents of the adoption, amendment or repeal of the rule shall be
called by the presiding officer to provide comment;
(d)
After all persons wishing to comment have been heard, the presiding
officer shall receive any written comment not previously submitted to the
board; and
(e)
After all written comment has been collected, the presiding officer shall
make closing remarks and adjourn the hearing.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 208.04 Oral Comment.
(a)
Any proponent of or opponent to the adoption, amendment or repeal of a
rule may make oral comment relative to such rule at the rulemaking hearing.
(b)
In order to be recognized at the hearing, any person wishing to comment
shall sign the speakers list at the hearing and wait to be called by the
presiding officer.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
Ph 208.05 Written Comment.
(a)
Any proponent or opponent may submit written comment to the board
pertaining to the adoption, amendment or repeal of a rule.
(b)
All written comment relative to proposed rulemaking shall be submitted
to the board in accordance with the notice of rulemaking, which shall set forth
a deadline allowing a minimum of 5 days time after adjournment of the
rulemaking hearing.
(c)
Written comment shall be submitted by filing an original and 2 copies
with the board.
Source.
#1639, eff 11-1-80; ss by #1909, 1-7-82; ss by
#2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by
#6094-B, INTERIM, eff 9-21-95, EXPIRED:
1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8315-A,
eff 3-26-05
PART Ph 209 EXPLANATION OF ADOPTED RULES
Ph 209.01 Requests for Explanation of Adopted Rules. Any interested person may, within 30 days of
the final adoption of a rule, request a written explanation of that rule by
making a written request to the board including:
(a)
The name and address of the individual making the request; or
(b)
If the request is that of an organization or other entity, the name and
address of such organization or entity and the name and address of the
representative authorized by the organization or entity to make the request.
Source.
#8315-B, eff 3-26-05, EXPIRED: 3-26-13
New. #12484,
eff 2-24-18
Ph 209.02 Contents of Explanation. The board shall, within 90 days of receiving
a request in accordance with Ph 209.01, provide a written response which:
(a)
Concisely states the meaning of the rule adopted;
(b)
Concisely states the principal reasons for and against the adoption of
the rule in its final form; and
(c)
States, if the board did so, why the board overruled any arguments and
considerations presented against the rule.
Source.
#8315-B, eff 3-26-05, EXPIRED: 3-26-13
New. #12484,
eff 2-24-18
CHAPTER Ph
300 LICENSING OF PHARMACISTS AND
PHARMACIES
PART Ph 301 LICENSING OF PHARMACISTS BY EXAMINATION
Ph 301.01 Application.
(a)
Application form Ph A-1, revised September 2015, for licensure to
practice the profession of pharmacy in
(b)
Applicants for licensure shall submit a completed form A-1 application
for licensure and file it at the office of the board identified in Ph 103.03
along with:
(1) A copy of the candidate's birth certificate;
(2) A recent, full face photograph of the
candidate;
(3) An official final transcript sent directly
from the college to the board office; and
(4) The prescribed fee which shall be $265.
(c)
An official final transcript shall be mailed directly from the college
to the board before either NAPLEX scores or
(d)
The photograph required by Ph 301.01 (b)(2) shall be attached to the
application form in the presence of a notary public or justice of the peace.
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a), (d), (e) and subparagraphs (b)(1)-(b)(10) EXPIRED: 2-5-04; amd
by #8316, eff 3-26-05; (b) intro., subparagraph (b)(11), and paragraph (c)
EXPIRED: 2-1-07; paragraphs (a), (d), (e) and subparagraphs (b)(1)-(b)(10)
EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.02 Additional Requirements. In addition to any requirements imposed by
statute, all candidates for a license to practice pharmacy in
(a)
The candidate shall be not less than 18 years of age;
(b)
The candidate shall be of good professional character, and not have been
convicted of any felony, or of a misdemeanor resulting from a violation of any
drug and/or pharmacy-related law or rule;
(c)
The candidate shall have graduated with a doctor of pharmacy degree (PharmD)
granted by a school of pharmacy, or a college of pharmacy, or a department of a
pharmacy of a university;
(d)
To meet the requirements of (c) above, the school, college or department
of pharmacy, shall be accredited by the Accreditation Council for Pharmacy
Education (ACPE) or the Canadian Council for Accreditation of Pharmacy Programs
(CCAPP).
(e) If a foreign graduate, in lieu of (c) and (d)
above, the candidate shall have graduated from a foreign college of pharmacy
other than Canada and have obtained full certification from the FPGEC
including:
(1) Passing the FPGEE with a score of at least
75; and
(2) Demonstrating proficiency in english by passing
the Test Of English as a Foreign Language Internet Based Test (TOEFL iBT).
(f)
Prior to the examination date, the candidate shall:
(1) Have completed an internship in pharmacy
which consists of:
a. At least 1500 hours, starting no earlier than
4 months prior to the third year of study in a college of pharmacy; and
b. Work
predominantly related to the practice of pharmacy including, but not limited
to:
1.
The selling of drugs and medical supplies;
2.
Interpreting, compounding, preparing and dispensing prescription orders;
3.
Preparing pharmaceutical products; and
4.
Keeping records and preparing reports required by federal and state
statutes.
(2) Have completed the internship record form Ph
A-3 revised September 2015 and submitted it to the board.
(g)
The candidate shall complete and pass the examinations described in Ph
301.03.
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraphs (e)-(g) EXPIRED: 2-1-07; paragraphs (a)-(d) EXPIRED:
3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.03 Required Examinations. The
examinations required for pharmacist licensure in
Source.
#6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.04 Required Examination Score. To successfully complete the NAPLEX and NH
MPJE examinations required by Ph 301.03, the candidate shall, on the initial
examination or any subsequent re-examination permitted by Ph 301.05, obtain a
score of not less than 75 on each examination.
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraph (a) and subparagraphs (b)(1) and (b)(3) EXPIRED: 2-5-04; amd by
#8316, eff 3-26-05; paragraph (b) and subparagraphs (b)(2) and (b)(4) EXPIRED:
2-1-07; paragraph (a) and subparagraphs (b)(1) and (b)(3) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 301.05)
Ph
301.05 Notice and Election of
Re-examination.
(a)
Any candidate who fails to obtain the minimum required score on either
of the 2 examinations required in Ph 301.03 may elect to retake the
examination.
(b)
All candidates shall notify the board in writing whether he/she elects
to be re-examined. The candidate for
re-examination shall register and pay for the re-take examination through the
National Association of Boards of Pharmacy online registration website
accessible at www.nabp.net.
Source.
#6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 301.06)
Ph 301.06 Issuance or Denial of Original License.
(a)
If candidate timely files an application, complete in all respects,
successfully completes all examinations required by Ph 301 and demonstrates the
complete fulfillment of the requirements of these rules, RSA 318, and RSA
318-B, the board shall issue a license to practice pharmacy.
(b)
In the event a candidate for an original license to practice pharmacy in
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (formerly Ph 301.07)
PART Ph 302 LICENSING OF PHARMACISTS BY RECIPROCITY
Ph 302.01 Reciprocity.
(a)
Instead of retaking the NAPLEX examination required by Ph 301.03, a
candidate may transfer the actual score he or she attained on the NAPLEX
administered by a state other than New Hampshire, provided that:
(1) The candidate is still duly licensed and is in
good standing in that state; and
(2) All other
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
subparagraphs (a)(1)-(a)(3) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (a) intro. EXPIRED; 2-1-07; subparagraphs (a)(1)-(a)(3) EXPIRED:
3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.02 Application.
(a)
The preliminary application for reciprocal licensure may be obtained
from a link provided on the NH board of pharmacy website or from the National
Association of Boards of Pharmacy,
(b)
Following verification of the applicant’s credentials by NABP the
applicant shall receive an official NABP license transfer application in the
mail.
(c)
The candidate shall file a completed NABP license transfer application provided
by the National Association of Boards of Pharmacy along with NH form Ph A-1,
revised September 2015, application for initial
licensure as a pharmacist in NH, and attach the following:
(1) A copy of the candidate's birth certificate,
or if born outside of the United States, a copy of the certificate of
naturalization or passport showing date of birth;
(2) A recent, full-face photograph of the
candidate attached to the application;
(3) An official copy of the candidate's pharmacy
college transcript mailed directly from the college to the board, or if a
foreign graduate, certification from the FPGEC; and
(4) The application fee of $265.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.03 Requirements. In addition to any requirements imposed by statute,
all candidates for licensure by reciprocity to practice pharmacy in
(a)
The candidate shall be not less than 18 years of age;
(b)
The candidate shall be of good professional character as evidenced by
the absence of conviction of any felony or of a misdemeanor resulting from a
violation of any drug and/or pharmacy related law or rule;
(c)
The candidate shall possess a professional pharmacy baccalaureate degree
or a doctor of pharmacy degree (PharmD) granted by a school of pharmacy, or a
college of pharmacy, or a department of pharmacy of a university accredited by
the Accreditation Council for Pharmacy Education (ACPE) or the Canadian Council
for Accreditation of Pharmacy Programs (CCAPP);
(d) A candidate who is a foreign
pharmacy graduate, other than Canadian, in lieu of (c) above, shall provide
written documentation that such candidate has:
(1) Obtained full certification from the FPGEC;
and
(2) Passed NAPLEX;
(e)
The candidate shall be licensed and in good standing in the state from
which he or she is seeking licensure transfer; and
(f)
The candidate for a reciprocal license shall complete and pass the NH
MPJE examination on the current federal and state laws and rules governing the
practice of pharmacy in the state of
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
(a) intro. and subparagraphs (a)(1)-(a)(3) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; subparagraphs (a)(4) and (a)(5) EXPIRED: 2-1-07; (a) intro. and
subparagraphs (a)(1)-(a)(3) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 302.04)
Ph 302.04 Reciprocity Application Time Limitation. Candidates who fail to complete the MPJE
examination, as required by Ph 302.03(f), within one year after the candidate's
application is received at the board office shall have their application
denied, but fees shall be retained by the board. If a candidate wishes to re-apply for
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
intro. paragraph and paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraphs (e)-(j) EXPIRED: 2-1-07; intro. paragraph and paragraphs
(a)-(d) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 302.06)
Ph 302.05 NH MPJE
Examination Required Scores and Fees.
(a)
To successfully complete the examination required by Ph 302.03(f), the
candidate shall, in the initial examination or any subsequent re-examination,
obtain a score of not less than 75.
(b) The candidate shall pay the current examination fee to, and as assessed by, NABP.
Source.
#6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.06 NH MPJE
Re-Examination Notice and Election.
(a)
Any candidate who has failed to attain the minimum score on the NH MPJE
examination as required by Ph 302.05, shall notify the board in writing whether
he or she elects to be re-examined.
(b)
Any candidate for re-examination of the NH MPJE examination shall
register and pay for the re-take examination through the National Association
of Boards of Pharmacy online registration website accessible at www.nabp.net.
Source.
#6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.07 Reciprocity License Issuance or Denial.
(a)
If a candidate timely files an application, complete in all respects and
meeting the requirements of Ph 302, and demonstrates the fulfillment of the
requirements of these rules and RSA 318 and RSA 318-B, the board shall issue a
license to practice pharmacy.
(b)
In the event a candidate for a reciprocity license to practice pharmacy
in New Hampshire fails to meet the requirements of these rules or RSA 318 and
RSA 318-B, or both, the board shall deliver to the candidate a written denial
of the application, specifying in detail each requirement which the candidate
failed to meet, and how the candidate is deficient.
Source.
#6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
amd by #8572, eff 2-23-06; paragraph (a) EXPIRED: 2-1-07; paragraph (b)
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (formerly Ph 302.09)
PART Ph 303 PHARMACY PERMIT OPTION
Ph 303.01 Licensing the Entire Store Area.
(a)
The pharmacy shall include the prescription department and all other
retail sections of the store.
(b)
The entire pharmacy shall be equipped with a functional alarm system to
prevent entry when the pharmacy is not open to the public, according to Ph
702.04.
(c)
The prescription department shall not be closed while the balance of the
establishment remains open.
(d)
A licensed pharmacist shall be on duty at all times when the pharmacy is
open to the public.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 303.02 Licensing Only the Prescription Department.
(a)
The pharmacy shall include only the prescription department where drugs,
chemicals, medicines, prescriptions are stored, compounded and dispensed. This area shall not include the other retail
sections of the store the principle business of which is not the practice of
pharmacy.
(b)
The prescription department described in (a), above, shall be equipped
with a functional alarm system to prevent entry when the pharmacy is not open
to the public according to Ph 702.04.
(c)
The prescription department may be closed while the remainder of the
business establishment remains open to the public. During such periods, the pharmacy shall
comply with Ph 702.04.
(d) A licensed pharmacist shall be on duty at all
times when the prescription department is open to the public and during any
absences by the pharmacist, the prescription department shall be secured except
as is provided in Ph 704.01(b).
(e)
Whenever the prescription department is closed, a sign indicating that
there is no pharmacist on duty shall be conspicuously displayed in the pharmacy
area. Such sign shall be composed of
3" lettering.
(f)
Whenever the prescription department is closed, prescriptions may be
left via a mail slot which falls directly into the pharmacy area.
(g)
The prescription mail slot:
(1) Shall be constructed so as to accept only a
written or typed prescription or a notation of the prescription number for
refills;
(2) Shall be no larger than 8" X 1" and
designed so that prescriptions or notations, once deposited, cannot be
retrieved by hand or by mechanical means; and
(3) Shall be constructed so as to deliver these
prescriptions or notations directly into the prescription area for access by
the pharmacist only so that they are not visible to the general public.
(h) No prescription, new or refill, shall be left
with or accepted by pharmacy technicians as defined in RSA 318:1, XI-b or
pharmacy interns as provided in RSA 318:42, IX when the prescription department
is closed except as is provided in Ph 704.01(c).
(i)
No finished prescriptions shall be left outside of the pharmacy area
prescription department for pick‑up when the prescription department is
closed.
(j) No telephone prescriptions, new or refill
shall be accepted by pharmacy technicians or pharmacy interns when the
prescription department is closed except as is provided in Ph 704.01(c).
(k)
All drug order deliveries containing prescription drugs shall be
delivered only when the prescription department is open and/or a licensed
pharmacist is on the premises in order to secure such drug orders.
(l)
A barrier preventing access to the prescription department by the
public, shall be erected pursuant to the security requirements of Ph 702.04(c).
(m)
The pharmacist-in-charge may designate personnel, in compliance with the
provisions of Ph 702.05(b), to have keys, and a list of these individuals shall
be communicated to the board of pharmacy in writing whenever changes occur.
(n)
All prescription departments licensed under this section shall be so
equipped with a physical barrier from floor to ceiling capable of being locked
and alarmed, separate from the rest of the store, to be utilized when the
prescription department is not opened to the public.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paragraphs (a)-(c), (e)-(g), (i), and (k)-(n) EXPIRED: 3-26-13;
paragraphs (d), (h), and (j) EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 304 PHARMACY PERMIT APPLICATION
Ph 304.01 Obtaining and Filing a Permit Application.
(a)
Application Ph B-1 revised September 2015 for a permit to operate a
pharmacy in New Hampshire may be obtained from the board or board website, and
shall be filed at the board office, identified in Ph 103.03;
(b)
Form Ph B-1 shall be used
for:
(1) Applying for a permit to operate a new
pharmacy within the State of
(2) Changing the location of a currently licensed
(3) Changing the ownership of a currently
licensed
(4) Changing the pharmacist-in-charge of a
currently licensed
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 304.02 Application Contents.
(a)
The applicant for a permit to operate a pharmacy in
(b)
The applicant shall also submit scale drawings of the pharmacy,
detailing usage of all space.
(c) The applicant shall supplement the
application with any certificates, affidavits, plans, documents, or other
information sufficient to show full compliance with all of the requirements of
Ph 304.
(d)
The applicant shall submit a certificate from the secretary of state
attesting to the documents creating the corporate person and any amendment(s) thereof
to the certificate of incorporation, or authorizing it to do business in the
state of
(e)
The application shall be filed with the prescribed fee of $250.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraph (e) EXPIRED: 2-1-07; paragraphs (a)-(d) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 305 PHARMACY PERMIT PROCEDURE
Ph 305.01 Pharmacy Permit Conference.
(a)
In addition to all requirements set forth in the statutes and elsewhere
in this chapter, each applicant applying for a permit to operate a pharmacy in
(b)
If the owner is not the pharmacist-in-charge, then the owner or an
officer of the corporation, or the district manager, as well as the anticipated
pharmacist-in-charge shall appear before the board.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 305.02 Site Inspection for Pharmacy Permit.
(a)
Following the applicant's conference, the proposed site shall be
inspected by one or more board members or compliance inspectors to determine if
the premises are secure and suitable, as set forth in the NH pharmacy
application information according to the provisions of Ph 702, for the
operation of a pharmacy and that the required professional library material,
according to Ph 702.07 (c) & (d), is available.
(b)
Within the 60 day period after the issuance of the temporary permit as
required by Ph 305.03, an inspector or a board member or both shall inspect the
pharmacy. The full operation of the
pharmacy shall be examined for compliance with federal and state statutes and
rules governing the practice of pharmacy to ensure public protection.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 305.03 Issuance and Denial of Pharmacy Permit.
(a) Applicants shall file a completed
application at least 30 days before consideration will be given for a temporary
permit.
(b)
Providing that, the premises are suitable, according to Ph 305.02 (a),
for the operation of a pharmacy and the applicant has met all other
requirements of these rules and RSA 318, the applicant shall be granted a
temporary permit which shall expire in 60 days.
The temporary permit shall authorize the operation of a pharmacy only in
the location and only under the name specified in the permit and shall
authorize the pharmacist-in-charge to buy, possess and dispense prescription
drugs, chemicals and pharmaceuticals.
(c)
After consideration of the application and the report of the primary
site inspection, the board shall notify the applicant in writing of all
deficiencies in the application which, in the absence of correction, shall
result in the denial of the application.
The applicant shall, within 20 days of the date of the notice of
deficiency, deliver to the board documents evidencing the correction of those
deficiencies. In the absence of
a timely filing of
documentation, the application shall, without further action or notice by the
board, be denied effective as of the expiration of 20 days after the date of
the notification of deficiency.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED: 4-21-15
New. #11031, eff 1-29-16
PART Ph 306 PHARMACY PERMITS - CHANGES IN SUPPORTING DATA
Ph 306.01 Pharmacy Ownership Transfer. A transfer of ownership shall include any of
the following:
(a)
The sale of the pharmacy;
(b)
The addition or deletion of one or more partners in a partnership;
(c)
The death of a singular owner; or
(d) In a publicly traded, multi-tiered
corporation, a change in the corporate ownership of the majority or controlling
interest of the lowest tier of the corporate structure doing business as a
pharmacy in the State of New Hampshire.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; intro. paragraph and paragraphs (a)-(c) EXPIRED: 3-26-13; paragraph
(d) EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.02 Reporting Changes. The person to whom a permit to operate a
pharmacy in New Hampshire has been issued shall, within 15 days of that
person's discovery of a change in any of the data contained in the application
for an original or renewal permit, report that change to the board in writing.
An original new permit application, form Ph B-1 revised September 2015 shall be
completed and filed in addition to the written notice when the name, location,
ownership, licensed area or pharmacist in charge of the pharmacy are changed.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.03 Change in Pharmacy Name or Location -
Prohibited. No person shall operate
a pharmacy under a name, or at a location, different from the name and location
contained in the permit issued pursuant to Ph 304.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.04 Renovations. Plans for any renovation at any time after
an original permit is issued shall be filed with the board for review and
approval before proceeding with such changes.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.05 Special Permit Provisions for Sudden
Termination of Pharmacist-In-Charge (PIC).
Existing pharmacy permit holders who have a sudden loss of the
pharmacist-in-charge (PIC), shall be issued a special pharmacy permit valid for
60 days while a new PIC is identified and appears before the board according to
Ph 305.01.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 307 RENEWAL AND REPLACEMENT PHARMACY PERMITS
Ph 307.01 Renewal Permits Required. The person to whom a permit to operate a
pharmacy in
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.02 Renewal Application Where Obtained and
Filed. Applications for the renewal of
a permit to operate a pharmacy in
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.03 Renewal Application Contents and When
Filed.
(a)
Applications for renewal of a permit to operate a pharmacy in
(b) Renewal applications as required pursuant to
Ph 307.01 shall be submitted to the board office identified in Ph 103.03 no
later than the 15th day of December of each year.
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraph (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; paragraph (a)
EXPIRED: 2-1-07; paragraph (b) EXPIRED:
3-26-13
New. #10702, INTERIM, eff 10-23-14, , EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.04 Renewal Application Deficiencies. The board shall notify the applicant in
writing as to how the application for renewal is deficient. The applicant may, within 10 days after the
date of the notice of deficiency, correct the deficiency or the renewal shall
be denied.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.05 Issuance
or Denial of Renewal Permit.
(a)
If an applicant shall timely file an application, complete in all respects,
and shall demonstrate the fulfillment of all the requirements of these rules
and RSA 318, the board shall issue a renewal permit.
(b)
An application which continues to fail to meet the requirements
of these rules and RSA 318 shall be denied.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.06 Replacement Permit Application and
Contents.
(a)
The holder of a current permit to operate a pharmacy in
(b)
The request for a replacement permit shall:
(1) Be in writing;
(2) Contain the number of the current permit held
by the applicant, if known;
(3) Be accompanied by the remains, if any, of the
permit for which a replacement is sought;
(4) Be accompanied by the prescribed fee of $25;
and
(5) Be filed at the board office.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 308 REVOCATION AND SUSPENSION OF A PHARMACY
PERMIT
Ph 308.01 Grounds for Revocation or Suspension. The board may revoke or suspend a permit to
operate a pharmacy for grounds which include but are not limited to:
(a)
Misconduct as described in RSA 318:29, II; and
(b)
Violations of the provisions of RSA 318:29, V.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 308.02 Effect of Revocation.
(a)
The revocation of a pharmacy permit shall permanently withdraw the
authority to operate a pharmacy in
(b)
A subsequent permit may be obtained only by:
(1) Complying with all of the requirements of RSA
318 and these rules regarding the original licensing of pharmacies;
(2) Paying all penalties assessed in connection
with the cause for revocation; and
(3) By
demonstrating that the cause for revocation does not exist at the time of the
subsequent application.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.01)
Ph 308.03 Effect of Suspension.
(a)
The suspension of a pharmacy permit shall temporarily withdraw the
authority to operate a pharmacy in
(b)
The authority to operate a pharmacy in
(1) Complying with all of the requirements
specified in the order of suspension;
(2) Complying with all of the requirements of RSA
318 and these rules regarding the renewal of a pharmacy permit; and
(3) Paying all penalties assessed in connection
with the cause for suspension.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.02)
Ph 308.04 Voluntary Surrender When Permitted.
(a)
Any person holding a pharmacy permit may voluntarily return that permit
to the board.
(b)
The return of such permit shall be accompanied by the licensee's signed,
written statement as to why the permit is being voluntarily returned to the
board.
(c)
The voluntary surrender of a permit to operate a pharmacy in
(d)
Voluntary surrender of a permit to operate a pharmacy in New Hampshire
shall not be permitted if there exists, at the time the permit is presented to
the board, any cause for involuntary revocation or suspension of the licensee's
permit to operate a pharmacy, unless the licensee presenting the permit shall
state in writing that the voluntarily surrendered permit is in lieu of
proceedings for the involuntary revocation or suspension of the permit to
operate a pharmacy in New Hampshire.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.03)
Ph 308.05 Hearing. Except as authorized by statute or these
rules, a permittee to operate a pharmacy in New Hampshire shall not be
disciplined except after notice and opportunity for hearing provided by Ph 200.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.04)
PART Ph 309
STANDARDS OF PRACTICE FOR MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS – Moved to Ph 1000
Ph 309.01 – Ph 309.14
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16; renumbered by #12007
(see Ph 1000)
CHAPTER Ph
400 CONTINUED STATUS
PART Ph 401 RENEWAL AND REPLACEMENT LICENSES
Ph
401.01 Obtaining and Filing Renewal
Applications. Applicants for renewal
of a license to practice pharmacy shall submit, by December 15th of
every even-numbered year, a Renewal License Form renewal form Ph A-2. The application may be obtained from the
board office. Alternatively, applicants
may file the renewal application online at https://nhlicenses.nh.gov/eGov/Login.aspx
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15;
ss by #13117, eff 10-15-20
Ph
401.02 Renewal Application Contents
and Filing Deadline.
(a) Applications for renewal of a license to practice
pharmacy in New Hampshire under RSA 318 shall be completed and filed biennially
by December 15th of each even-numbered year.
(b) With the exception of authorized immunizing
pharmacists per the provisions of Ph 1300, which shall have the combined renewal fee as noted below in (c), the
application and the prescribed fee of $250
shall be filed with the board no later than December 15th of
each even-numbered year. Each licensee shall complete and file his or her
application for license renewal prior to this date.
(c) The biennial renewal fee for pharmacists who are authorized immunizing pharmacists
shall be $270, which includes a fee for the immunization endorsement on their
pharmacist license.
(d) Per the provisions of RSA 318:29-a, VI(b), $30
of each biennial pharmacist renewal fee noted in sections (b) and (c) above shall be used to fund the
impaired pharmacist program.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a) and (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd
by #9139-B, eff 4-25-08; paragraphs (a) and (b) EXPIRED: 3-26-13; ss by #10842,
eff 6-3-15; ss by #13117, eff 10-15-20
Ph 401.03 Renewal Application Deficiencies. Within 5 days of receipt at the board office,
the board shall notify the applicant in writing if the renewal application is
deficient. The applicant may then
correct the deficiency or file with the board a written request for a hearing
before the board.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.04 Renewal License Issuance and Denial.
(a) If an applicant timely files an application,
complete in all respects, and demonstrates the fulfillment of all the
requirements of these rules and RSA 318, the board shall issue a renewal
license to practice pharmacy.
(b) Applicants shall register with the New
Hampshire Prescription Drug Monitoring Program pursuant to the requirements
articulated in RSA 318-B:33, II and Ph 1503.01 (a).
(c) An application failing to meet the
requirements of these rules or RSA 318, or both, shall, after the notice and
opportunity for hearing, be denied.
(d) Applicants who fail to register for the New
Hampshire Prescription Drug Monitoring Program pursuant to RSA 318-B:33, II and
Ph 1503.01 (a), shall, after the notice and opportunity for hearing, be denied.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.05 Duplicate/Replacement Original Certificate
of Licensure or Renewal License - Issuance.
(a)
If seeking a duplicate or replacement for an original certificate of
licensure the applicant shall:
(1) Submit a written request, signed by the
pharmacist, to the board for replacement; and
(2) Provide payment of the prescribed fee which
shall be $50.
(b)
If seeking a duplicate or replacement
for an annual renewal license the applicant shall:
(1) Submit a written request, signed by the
pharmacist, to the board for a duplicate or replacement; and
(2) No fee shall be assessed for a duplicate or
replacement renewal license.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.06 Reinstatement. A pharmacist whose license to practice
pharmacy in this state has been suspended, revoked, voluntarily surrendered or
allowed to lapse shall be subject to the following requirements:
(a)
File a reinstatement application with the board which shall include at
least the following:
(1) Name, address and telephone number of the
applicant;
(2) Date
of birth; and
(3) Current employment information.
(b)
Pay the reinstatement fee of $200;
(c)
Submit certificates of attendance/participation in accredited/approved
continuing pharmaceutical education courses/programs for a minimum of 15 hours,
of which at least 5 hours shall be earned in a live setting. All such continuing education shall have been
earned in the period 12 months immediately preceding the date of application
for reinstatement;
(d)
Successfully complete the jurisprudence MPJE examination as specified in
Ph 302.07(a);
(e)
If the pharmacist has not held a license to practice pharmacy in this
state for a period of 2 years or more, the applicant shall provide:
(1) Notarized affidavit(s) documenting the
pharmacist's pharmacy experience during the 2 years immediately preceding the
date of his/her application for reinstatement; and
(2) Proof of status of licensure in all states
that the pharmacist has been licensed in; and
(f)
If the pharmacist has not held a license to practice pharmacy in this
state for a period of 5 years or more and has not practiced pharmacy in any
other state, the board shall require the completion of a period of pharmacy
practice internship prior to reinstatement.
Source.
#2442, eff 9-1-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; intro. paragraph and paragraphs (a)-(d) and (f)-(g) EXPIRED:
2-5-04; amd by
#8316,
eff 3-26-05; paragraph (e) EXPIRED: 2-1-07; intro. paragraph and paragraphs
(a)-(d) and (f)-(g) EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.07 Gold Certificates.
(a)
The board of pharmacy shall issue a gold certificate to any pharmacist
who has been regularly licensed as a pharmacist in
(b)
Gold certificates shall be distinctive in coloration and text from other
pharmacist licenses issued by the board, and shall be designed to appropriately
recognize each recipient pharmacist for his/her half‑century of
professional practice.
(c)
A gold certificate shall be a one-time issuance of honorary nature and
confer no right to practice pharmacy upon the recipient.
(d)
The awarding of gold certificates shall be made by the board of pharmacy
without charge to the recipient.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 402 DISCIPLINARY MATTERS
Ph 402.01 Effect of Revocation.
(a)
The revocation of a pharmacist license shall permanently withdraw the
authority to practice pharmacy in
(b)
A subsequent license may be obtained only by:
(1) Complying with all of the requirements of RSA
318 and these rules regarding the original licensing of pharmacists;
(2) Paying all penalties assessed in connection
with the cause for revocation; and
(3) Demonstrating that the cause for revocation
does not exist at the time of the subsequent application.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.02 Effect of Suspension.
(a)
The suspension of a pharmacist license shall temporarily withdraw the
authority to practice pharmacy in
(b)
The authority to practice pharmacy in
(1) Complying with all of the requirements
specified in the order of suspension;
(2) Complying with all of the requirements of RSA
318 and these rules regarding the renewal of a license to practice pharmacy in
New Hampshire; and
(3) Paying all penalties assessed in connection
with the cause for suspension.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.03 Voluntary Surrender of License.
(a)
Any person holding a pharmacist license may voluntarily surrender that license
by returning it to the board accompanied by a signed letter stating that the
pharmacist intends to permanently surrender his or her license.
(b)
The surrender shall be effective upon acceptance by the board and shall immediately preclude the
pharmacist from practicing pharmacy in
(c) A voluntary license surrender,
standing alone, shall not prevent the pharmacist from subsequently reapplying
for a license.
(d)
The voluntary surrender of a license shall have no effect upon the
board's authority to:
(1) Investigate violations of the pharmacy laws
or the rules of the board by a person licensed at the time the alleged
violation occurred; or
(2) Impose disciplinary sanctions based on past
conduct which could affect the ability of the former licensee to reapply for a
license at a later date.
(e)
A voluntary license surrender during the pendency of a disciplinary
proceeding shall be recorded in the board's files as "surrendered during
disciplinary proceeding."
(f)
Nothing in this section shall prohibit the board and a licensee from
entering into a settlement agreement or a consent decree relative to any
alleged violation of the pharmacy laws or the rules of the board.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.04 Hearing. Except as authorized by statute or these rules,
a licensee shall not be disciplined except after notice and opportunity for
hearing.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 403 CONTINUING EDUCATION REQUIREMENTS
Ph 403.01 Definitions.
(a)
"Accredited programs/courses" means continuing education
sponsored by providers which are approved by the American Council on
Pharmaceutical Education (ACPE) or the Canadian Council on Continuing Education
in Pharmacy (CCCEP).
(b)
“AMA category I programs” means all programs accepted by the American
Medical Association in category I.
(c)
"Board approved programs/courses" means continuing education
which has been reviewed and recommended by the continuing education advisory
council and approved by the board of pharmacy or continuing education programs
approved by a Canadian provincial or territorial pharmacy licensing authority.
(d)
“Certificate of accredited/approved CEU's” means a document, issued to a
particular pharmacist by an accredited or approved provider certifying that the
pharmacist has satisfactorily completed a specified number of CEU's. Such certificates include a unique program
identification number issued by the accrediting/approving provider.
(e)
“Continuing education” means accredited or approved post‑licensure
pharmacy education designed to maintain professional competence in the practice
of pharmacy, improve professional skills, and preserve pharmaceutical standards
for the purpose of protecting the health and welfare of the citizens in the
state of
(f)
“Continuing education advisory council (CEAC)” means a group of
individuals appointed by the board of pharmacy to serve in an advisory capacity
on continuing education.
(g)
“Continuing education unit (CEU)” means 10 contact hours of
participation in accredited or board approved continuing education
courses/programs.
(h) “In-state approved provider” means
an individual, institution, organization, association, corporation or agency
located in the state of New Hampshire in no manner affiliated with any
manufacturer or distributor of supplies or services used in the practice of
pharmacy, who is approved by the board of pharmacy to provide continuing
pharmacy education according to Ph 403.12.
Source.
#1867, eff 11-22-81; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (c)-(h) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraphs (a) and (b) EXPIRED: 2-1-07; paragraphs (c)-(h) EXPIRED:
3-26-13
New. #10812, eff 4-18-15
Ph 403.02 Renewal Requirements.
(a)
The board shall not issue licensure renewals unless the pharmacist
indicates on the renewal application, and under penalty of unsworn
falsification, that he or she has completed the minimum required hours of
accredited or approved continuing pharmaceutical education courses or programs
according to Ph 403.02(d). An incomplete
renewal application shall not be processed by the board.
(b)
Continuing education shall be required of all licensed, active or
inactive pharmacists who apply for license renewal.
(c)
Pharmacists submitting applications for their first biennial licensure renewal
shall be exempt from the continuing education requirements.
(d)
All pharmacists licensed in New Hampshire shall acquire a total of 30
hours (3.0 CEUs) during the 24 months immediately preceding the license renewal
date of January 1st. At least 10 hours
(1.0 CEUs) of the total required hours shall be earned in a live setting.
(e) Continuing education credits shall
not be recognized for any repeat program attended or completed. Repeat programs shall be identified as any
program, live or correspondence, which carries the same ACPE, CME, or any board
program identification number.
(f)
The pharmacist shall retain all certificates and other documented
evidence of participation in an approved or accredited continuing education
program or course for a period of at least 3 years. Such documentation shall be made available to
the board for random audit or verification purposes.
(g)
Not less than 10% of the registrants shall be randomly selected by the
board after October 1 of every even numbered year for determinations of
compliance with Ph 403.02.
Source.
#1867, eff 11-22-81: ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a)-(f) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraph (g) EXPIRED: 2-1-07; paragraphs (a)-(f) EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13117, eff
10-15-20
Ph 403.03 Excess CEU's. Excess CEU's earned in one licensure period
shall not be carried forward into the new licensure period.
Source.
#1867, eff 11-22-81: ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13117, eff
10-15-20
Ph 403.04 CEU's from Other States. The board of pharmacy shall accept comparable
continuing education units which have been approved by other boards of pharmacy
provided they meet or exceed the requirements as set forth in Ph 403.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.05 Credit for Instructors of Continuing
Education.
(a)
Any pharmacist, whose primary responsibility is not the education of
health professionals, who leads, instructs or lectures to groups of nurses,
physicians, pharmacists or others on pharmacy related topics in organized
continuing education or in-service programs, shall be granted continuing
education credit for such time expended during actual presentation.
(b)
Any pharmacist whose primary responsibility is the education of health
professionals shall be granted continuing education credit only for time
expended in leading, instructing, or lecturing to groups of physicians,
pharmacists, nurses or others on pharmacy-related topics outside his/her formal
course responsibilities in a learning institution.
(c)
Credit for presentation of in-service training programs or other
lectures shall be granted only once for any given program or lecture.
(d)
A maximum of 4 hours in this category may be applied toward fulfilling
the total continuing education yearly requirements. However, these hours shall not be considered
in fulfilling the live requirements as set forth in Ph 403.02(d).
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.06 Postgraduate Pharmacy Curricula.
(a)
A pharmacist who matriculates in a postgraduate pharmacy curriculum or
post graduate pharmacy program shall be awarded CEU's for satisfactory
completion of each course within said curriculum or program.
(b)
The course work for which CEU credit is provided pursuant to (a) above,
shall provide instruction in one or more of the following areas of study:
(1) Pharmacy;
(2) Pharmaceutical calculations;
(3) Pharmaceutical chemistry;
(4) Pharmacology;
(5) Therapeutics;
(6) Pharmacy management;
(7) Pharmaceutical jurisprudence; or
(8) Other course work related to the
pharmaceutical sciences.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.07 Audio/Visual Continuing Education.
(a)
Continuing education credit may be claimed for the completion of home
study audio and/or video cassette tape programs/courses, provided that such
programs require the completion of a written exam by the pharmacist to be
scored by the provider of such programs.
(b)
Audio/visual continuing education programs, including satellite
transmissions, which provide for group discussion and include a facilitator
shall, be allowed as live programming.
(c)
Webinars that are ACPE approved and contain an “L” in the program
approval number shall be allowed as live programming.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.08 Waiver. The board shall waive some or all of the
continuing education requirements, for a period not to exceed one calendar
year, for such hardships as illness or incapacity. Written request for waiver shall be submitted
to the board for consideration.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.09 Military Personnel. Military personnel or spouses shall not be
exempt from the continuing education requirements, because correspondence
programs/courses are available, but shall be exempt from the live requirement
if assignment is in a foreign country.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.10 Reinstatement. Any pharmacist desiring reinstatement of
licensure shall show evidence of completion of at least 1.5 CEU's, according to
Ph 403.02(d) and earned in the 12 months immediately preceding the date of
application for reinstatement.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.11 Penalty. Any pharmacist who alters, forges, or
intentionally falsifies, or causes to be altered, forged, or falsified any
information, documents, or records required to be kept or submitted by this
rule shall be subject to disciplinary action under RSA 318:29, II. Falsification of records shall constitute
misconduct.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.12 In-State Approved Providers of Continuing
Pharmacy Education.
(a)
An individual, institution, organization, association, corporation or
agency located in the state of
(b)
Approval of in-state providers shall be valid for a period of 2 years
from date of approval after which time re-application shall be necessary.
(c)
In-state providers who desire to become approved by the board shall
provide their educational qualifications and an example of a program to the
CEAC committee for review.
(d)
In state providers shall
comply with the following:
(1) The provider shall designate a responsible
person for the administration of the continuing pharmacy education program and
liaison with the CEAC and the board;
(2) Providers shall award continuing pharmacy
education credit to successful participants in terms of CEU's;
(3) The provider shall maintain a list of
successful participants for each program provided for a period of not less than
3 years;
(4) The list required by (3) above shall be made
available to the CEAC and the board on request;
(5) The provider shall award to each successful
participant a certificate containing at least the following information:
a. The name of the provider;
b. The completion date of the continuing
education program;
c. The name of the participant;
d. The title of the program;
e. The number of CEU's the program has been
assigned; and
f. The board of pharmacy program identification
number.
(6) All programs shall be referenced as
"live" or "correspondence" in nature;
(7) Providers shall present their participants
with a statement of goals and objectives prior to each continuing pharmacy
education program and involve their participants in identifying their own
educational needs;
(8) Providers shall develop and employ evaluation
techniques that will assess the effectiveness of the continuing pharmacy
education offerings and the level of fulfillment of the stated objectives with
the goal of continual improvements;
(9) Providers shall utilize an evaluation
mechanism for the purpose of allowing each participant to assess his/her
achievement of personal objectives; and
(10) Providers shall assign an identification number
to every program presented according to the numbering system designated by the
board of pharmacy.
(e)
Continuing education programs presented by in-state approved providers
shall not have to be submitted to the CEAC for review and
approval by the board.
(f)
In-state approved providers of continuing pharmacy education shall
publicize programs and/or coursework by referencing endorsement by the board
only as follows: "This program is
approved by the New Hampshire Board of Pharmacy for CEU's of continuing pharmacy
education". Programs shall also be
referenced as "live" or "correspondence" in nature.
(g)
Board approval of in-state provider shall be revoked following notice
and opportunity to be heard upon a finding that the provider has engaged in
fraud or dishonesty or is no longer in compliance with one or more of the
criteria of (d) above.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.13 Continuing Education Advisory Council
Membership.
(a)
The advisory council shall consist of not less than 6, nor more than 10
members, at least one of whom shall be a member of the board.
(b)
The term of appointment shall be for 3 years and shall be served until
the expiration date or until a successor has been named. Should a vacancy occur, a successor shall be
appointed to serve the unexpired term.
(c)
The advisory council shall submit all recommendations to the board for
its implementation and/or approval.
(d)
It shall be the duty of the advisory council to:
(1) Elect from its membership a chairman and a
secretary annually;
(2) Recommend to the board the standards and
specifications required of programs/courses which might be acceptable for board
approval in fulfilling continuing education requirements;
(3) Recommend programs which meet the standards
and specifications adopted;
(4) Recommend the
number of CEU's granted for the satisfactory completion of approved programs;
and
(5) Provide such other assistance to the board
necessary in the implementation and maintenance of the continuing education
licensure renewal prerequisite.
(e)
The advisory council shall meet a sufficient number of times annually to
properly perform its functions.
(f)
The advisory council quorum shall be equal to the majority of the
council membership.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 404
STANDARDS FOR COMPOUNDING AND DISPENSING STERILE AND NON-STERILE PHARMACEUTICALS
Ph 404.01 Purpose and Scope.
(a) The purpose of
this part is to provide all compounders with guidance on applying good
compounding practices for the preparation of non-sterile and sterile compounded
formulations for dispensing and/or administration to humans and animals.
Compounding is an integral part of pharmacy practice and is essential to the provision
of healthcare.
(b) The board shall require all compounders
engaging in compounding in all situations to adhere to and comply with the
current edition of the United States Pharmacopeia including but not limited to
Chapters 795 (USP 795) and 797 (USP 797), following those guidelines that apply
to their practice setting. These chapters shall be reviewed in full and
followed by compounders prior to non-sterile or sterile pharmaceutical
compounding. These regulations shall apply to non-sterile and sterile
compounding of medications.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.02 Definitions.
(a)
“Active pharmaceutical ingredients” means chemicals, substances, or
other components of articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in humans or animals or for
use as nutritional supplements.
(b)
“Added substances” means the ingredients necessary to prepare the drug
product but are not intended or expected to cause human pharmacological
response if administered alone in the amount or concentration contained in a
single doses of the compounded preparation.
The term “added substances” includes
the terms “inactive ingredients”, “excipients”, and “pharmaceutical
ingredients.”
(c)
“Ante-area” means:
(1) An ISO Class 8 or better area where personnel
perform hand hygiene and garbing procedures, staging of components, order
enter, CSP labeling, and other high-particulate-generating activities are
performed;
(2) A transition area that:
a. Provides assurance that pressure relationships
are constantly maintained so that air flows from clean to dirty areas; and
b. Reduces the
need for the heating, ventilating, and air-conditioning (HVAC) control system
to respond to large disturbances.
(d)
“Aseptic processing” means a mode of processing pharmaceutical and
medical products that involves the separate sterilization of the product and of
the package containers, closures or packaging material for medical devices and
the transfer of the product into the container and its closure under at least
ISO Class 5 conditions.
(e)
“Beyond-use date (BUD)” is
the date after which a compounded preparation should not to be used; determined
from the date the preparation is compounded.
(f)
“Biological Safety Cabinet (BSC)” means a ventilated cabinet for CSPs,
personnel, product, and environmental protection having an open front with
inward airflow for personnel protection, downward high-efficiency particulate
air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted
air for environmental protection.
(g)
“Buffer area” means an area where the primary engineering control (PEC)
is physically located.
(h)
“Clean room” means a room in which the concentration of airborne
particles is controlled to meet a specified airborne particulate cleanliness
class. Microorganisms in the environment are monitored so that a microbial
level for air, surface, and personnel gear are not exceeded for a specified
cleanliness class.
(i)
“Component” means any ingredient used in the compounding of a drug
preparation, including any active ingredient or added substance that is used in
its preparation.
(j)
“Compounder” means a licensed professional authorized by the appropriate
jurisdiction to perform compounding pursuant to a prescription or medication
order by a licensed prescriber.
(k)
“Compounding” means the preparation, mixing, assembling, altering, packaging,
and labeling of a drug, drug-delivery device, or device in accordance with a
licensed practitioner's order, or initiative based on the
practitioner/patient/pharmacist/compounder relationship in the course of
professional practice, and includes the following:
(1) Preparation of drug dosage forms for both
human and animal patients;
(2) Preparation of drugs or devices in
anticipation of prescription drug orders based on routine, regularly observed
prescribing patterns;
(3) Reconstitution or manipulation of commercial
products that may require the addition of one or more ingredients;
(4) Preparation of drugs or devices for the
purposes of, or as an incident to research clinical or academic teaching, or
chemical analysis; and
(5) Preparation of drugs and devices on the order
of a practitioner, which may be sold to the practitioner for use in his or her
office to administer to a specific patient, in limited quantities, but not for
resale.
(l) “Compounding Aseptic Containment
Isolator (CACI)” means a compounding aseptic isolator (CAI) designed to provide
worker protection from exposure to undesirable levels of airborne drug
throughout the compounding and material transfer processes and to provide an
aseptic environment for compounding sterile preparations.
(m) “Compounding Aseptic Isolator
(CAI)” means a form of isolator specifically designed for compounding
pharmaceutical ingredients or preparations. It is designed to maintain an
aseptic compounding environment within the isolator throughout the compounding
and material transfer processes.
(n)
“Critical area” means an ISO Class 5 environment.
(o)
“Critical site” means a location that includes any component or fluid
pathway surfaces such as vial septa, injection ports, beakers or openings such
as opened ampules or needle hubs exposed and at risk of direct contact with air
including ambient room or HEPA filtered, moisture such as oral and mucosal
secretions, or touch contamination. Risk
of microbial particulate contamination of the critical site increases with the
size of the openings and exposure time.
(p)
“Direct Compounding Area (DCA)” means an area within the ISO Class 5
primary engineering control (PEC) where critical sites are exposed to
unidirectional HEPA-filtered air, also known as first air.
(q)
“Disinfectant” means an agent that frees from infection, usually a
chemical agent but sometimes a physical one, and that destroys disease-causing pathogens
or other harmful microorganisms but might not kill bacterial and fungal spores.
It refers to substances applied to inanimate objects.
(r)
“First air” means the air exiting the HEPA filter in a unidirectional
air stream that is essentially particle free.
(s)
“Hazardous drugs” means any drug which in studies of animals or humans
have been classified as carcinogenic, toxic to development or reproduction, or
toxic to organs.
(t)
“Labeling” means a term that designates all labels and other written,
printed, or graphic matter on an immediate container of an article or
preparation or on, or in, any package or wrapper in which it is enclosed,
except any outer shipping container. The
term “label” designates that part of the labeling on the immediate container.
(u) “Limited quantities” means a batch
with 50 or less dosage units provided to a hospital or practitioner to
administer to their own patient.
(v)
“Manufacturing” means the production, preparation, propagation,
conversion or processing of a drug or device, either directly or indirectly, by
large volume extraction from substances of natural origin, or independently by
means of chemical or biological synthesis, and includes any packaging or
repackaging of a substance or labeling or relabeling of its container, and the
promotion and marketing of such drugs and devices for resale.
(w)
“Media-fill test” means a test used to qualify aseptic technique of
compounding personnel or processes and to ensure that the processes used are
able to produce sterile product without microbial contamination. During this test, a microbiological growth
medium such as Soybean–Casein Digest Medium is substituted for the actual drug
product to simulate admixture compounding.
(x)
“Memorandum of understanding” means a document specific to the
preparation(s) provided to a practitioner by a compounder outlining the
distinct responsibilities of the compounder and practitioner.
(y)
“Multiple-dose container” means a multiple-unit container for articles
or preparations intended for parenteral administration only and usually
containing antimicrobial preservatives.
(z)
“Negative pressure room” means a room that is at a lower pressure than
the adjacent spaces and, therefore, the net flow of air is into the room.
(aa) “Pharmacy bulk package” means a
container of a sterile preparation for parenteral use that contains many single
doses. The contents are intended for use
in a pharmacy admixture program and are restricted to the preparation of
admixtures for infusion or, through a sterile transfer device, for the filling
of empty sterile syringes.
(ab)
“Positive pressure room” means a room that is at a higher pressure than
the adjacent spaces and, therefore, the net airflow is out of the room.
(ac)
“Preparation” means a compounded drug dosage form or dietary supplement
or a device to which a compounder has introduced a drug.
(ad) “Primary Engineering Control
(PEC)” means a device or room that provides an ISO Class 5 environment for the
exposure of critical sites when compounding CSPs. Such devices include, but are not limited to,
laminar airflow workbenches (LAFWs), BSCs, CAIs, and CACIs.
(ae)
“Product” means a commercially manufactured sterile drug or nutrient
that has been evaluated for safety and efficacy by the FDA.f
(af)
“Segregated compounding area” means a designated space, either a
demarcated area or room, that is restricted to preparing low-risk level CSPs
with 12-hour or less BUD. This area
shall contain a device that provides unidirectional airflow of ISO Class 5 air
quality for preparation of CSPs and shall be oid of activities and materials
that are extraneous to sterile compounding.
(ag)
“Single-dose container” means a single-unit container for articles or
preparations intended for parenteral administration only. It is intended for a single use. A single-dose container is labeled as such.
Examples of single-dose containers include prefilled syringes, cartridges,
fusion-sealed containers, and closure-sealed containers when so labeled.
(ah)
“Sterilization by Filtration” means passage of a fluid or solution
through a sterilizing grade membrane to produce a sterile effluent.
(ai) “Sterilizing grade members” means that
membranes that are documented to retain 100% of a culture of 107 microorganisms
of a strain of Brevundimonas (Psuedomonas) diminuta per square centimeter of
membrane surface under a pressure of not less than 30 psi or 2.0 (bar). Such filter membranes are nominally at
0.22-um or 0.2-um nominal pore size, depending on the manufacturer’s practice.
(aj) “Terminal Sterilization” means the
application of a lethal process, such as steam under pressure or autoclaving,
to sealed containers for the purpose of achieving a predetermined sterility
assurance level of usually less than 10-6, or a probability of less than one in
one million of a non-sterile unit.
(ak) “Unidirectional flow” means the airflow
moving in a single direction in a robust and uniform manner and at a sufficient
speed to reproducibly sweep particles away from the critical processing or
testing area.
(al) “United States Pharmacopia” means a legally
recognized compendium of standards for drugs.
(am) “Vehicle” means a component for internal and
external use that is used as a carrier for diluent in which liquids, semisolids
or solids are dissolved or suspended.
Examples include, but are not limited to, water, syrups, elixirs,
oleaginous liquids, solid and semisolid carriers and proprietary products.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.03 Non-Sterile Pharmaceutical Compounding.
(a) Compliance with USP 795 and all applicable
USP chapters related to non-sterile compounding shall be followed.
(b) There are 3 general categories of non-sterile
compounding described in this section that require different levels of
experience, training and physical facilities. The 3 categories shall be:
(1) Simple compounding which includes
reconstituting or manipulating a commercial product that might require the
addition of one or more ingredients as directed by the manufacturer or preparing a product that has a USP compounding monograph or appears in a peer reviewed
article that contains the quantities
for all components, procedures and equipment with the exception of pre-measured
compounding kits;
(2) Moderate
compounding which includes making a preparation that requires complex
calculation or procedures to determine quantities of components per preparation
or per individualized dosage units, making a preparation for which stability
data for that specific formulation is not available and mixing 2 or more
manufactured creams when the stability of the mixture is unknown; and
(3) Complex
compounding which includes making a preparation that requires specialized
training, environment, facilities, equipment, and procedures such as
transdermal dosage forms and modified-release preparations.
(c)
Responsibilities of the compounder shall include:
(1) Compounding preparations of accepted strength,
quality, and purity and in accordance with the prescription or medication
order;
(2) Dispensing the
finished preparation, with appropriate packaging and labeling, and in
compliance with RSA 318:47-a, federal law, and other regulatory agencies where
appropriate;
(3) Maintaining proficiency in drug or dietary
supplement compounding;
(4) Ensuring
the quality of compounded preparation by adhering to the general principles
listed in USP 795 and all applicable compounding laws, guidelines and standards
including but not limited to:
a. Training of all the personnel shall be
current and documentation of such kept on site;
b. Compounding
ingredients shall be purchased from reliable sources and be properly stored;
c. Bulk component containers shall be properly
labeled and SDS sheets available;
d. Equipment used shall be clean, properly used
and maintained;
e. Environment shall be suitable to prevent cross
contamination including the use of powder containment systems if API’s are used
or powder is created through manipulation of solid dosage forms or emptying of
powder containing vials;
f. Compounding personnel shall wear appropriate
and clean clothing. Protective apparel
such as lab coats gowns, gloves, shoes, or masks shall be worn as necessary to
protect personnel from chemical exposure and/or contamination;
g. Only authorized personnel shall be allowed in
the compounding area;
h. Compounding conditions and procedures shall
be such to prevent errors;
i. There shall be assurance that processes are
always carried out as intended or specified and are reproducible;
j. All aspects of compounding shall be properly
documented;
k. Procedures and records exist for
investigating and correcting failures or problems in compounding and testing;
and
l. A valid and reproducible recall policy and
procedure.
(5) The compounder shall be responsible for
ensuring that each individual incidence of the compounding process meets the
criteria in USP 795.
(d)
The compounding area shall adhere to the general principles listed in
USP 795 guidelines including but not limited to:
(1) Adequate space
specifically designated for compounding and storage of equipment and materials;
(2) Be clean, orderly, and properly maintained;
(3) Easily accessible hand washing, hot and cold
water, soap or detergent, and an air-drier or single-use towels must be present;
(4) Be located in a separate area from sterile
compounding area;
(5) Purified water
shall be used for compounding non-sterile drug preparations when formulations
indicate the inclusion of water;
(6) Disposal of
all hazardous drug wastes shall comply with applicable federal and state
regulations; and
(7) All personnel who perform routine custodial
waste removal and cleaning activities in storage and preparation areas for
hazardous drugs shall be trained in appropriate procedures to protect themselves
and prevent contamination including spill clean ups.
(e)
All equipment and utensils used in compounding shall comply with the
following:
(1) Be of appropriate design and capacity for the
required task;
(2) Automatic, mechanical,
electronic, or other equipment used in compounding shall be routinely
inspected, calibrated, or checked according to the manufacturer’s
recommendations to ensure proper performance; and
(3) Equipment shall be stored to protect it from
contamination. It shall be located in an
area to facilitate its use, cleaning and maintenance.
(f)
Component Selection, Handling and Storage shall be subject to the
following requirements:
(1) A United States Pharmacopeia (USP), National
Formulary (NF), or Food Chemicals Codex (FCC) substance shall be the
recommended source of ingredients for compounding all preparations.
(2) If ingredients
are from a non-FDA registered facility the professional judgment of the
compounder shall be used in selecting an acceptable and reliable source and
shall establish purity and safety including obtaining a certificate of analysis
from the manufacturer or qualified third party;
(3) Components for compounding shall be properly
labeled with lot numbers and expiration dates. If a component is transferred from the
original container to a new container, the new container shall be labeled with
the component name, original supplier, lot or control number, transfer date,
and expiration date and shall provide integrity that it is equal to or better
than the original container;
(4) For components that do not have expiration
dates assigned by the manufacturer or supplier the compounder shall label the
container with the date of receipt and assign a conservative expiration date
not to exceed 3 years after receipt;
(5) Written control procedures shall be
established to monitor the output and to validate the performance of those
compounding processes that might be responsible for causing variability in the
final drug product, including but
not limited to, the following:
a. Capsule weight variation;
b. Adequacy of mixing to insure uniformity and
homogeneity;
c. Clarity, completeness, or pH of solutions;
and
d. Observation of instability;
(6) When compounding with manufactured drug
products, the compounder shall consider all ingredients, including excipients,
present in the drug product relative to the intended use of the compounded
preparation and the effect of manipulating the drug product on the therapeutic
appropriateness and stability of the components;
(7) All components used in compounding shall be
stored as directed by the manufacturer, or according to USP or NF requirements,
in a clean, dry area under appropriate temperature conditions. All components shall be stored off the floor,
handled and stored to prevent contamination, and rotated so that the oldest
stock is used first. All containers
shall be properly labeled; and
(8) Use
of pre-measured compounding kits shall adhere to all USP 795 standards,
including the level of non-sterile compounding and utilizing a master
formulation record and a compounding record.
(g)
The following provisions of USP 795 shall be followed when determining
stability and beyond use dating:
(1) Compounders shall consult and apply
drug-specific and general stability information and literature when available;
(2) Compounders shall consider the following when
determining BUDs:
a. Nature of the drug and degradation mechanism;
b. Dosage form and its components;
c. Potential for microbial proliferation in the
preparation;
d. Container when it is packaged;
e. Intended duration of therapy; and
f. Expected storage conditions;
(3) When using manufactured solid dosage forms to
prepare a solution or aqueous suspension, the compounder shall also consider
factors such as hydrolysis, oxidation, and the freeze - thaw property of the
final preparation;
(4) When a manufactured product is used as the
source of the active pharmaceutical ingredient for a non-sterile compounded
preparation, the product expiration date shall not be used to assign a BUD for
the compounded preparation. Instead the
compounder shall refer to the manufacturer for stability information and to the
literature for applicable information on stability, compatibility, and
degradation of ingredients. All data shall be carefully interpreted in relation
to the actual compounded formulation;
(5) Susceptible preparations should contain
suitable antimicrobial agents to protect against bacteria, yeast, and mold
contamination inadvertently introduced during
or after the compounding process. When
antimicrobials are contraindicated, storage of the preparation at controlled
cold temperature shall be necessary to retard microbial growth. Appropriate patient or caregiver instruction
regarding storage and handling shall be essential;
(6) In the absence of reliable stability information
or published date the following general guidelines for maximum BUD shall be:
a. A maximum of 6 months for non-aqueous
formulations;
b. A maximum of 14 days under refrigeration for
water-containing oral formulations; and
c. A maximum of 30 days for water containing
topical, dermal and mucosal liquid and semisolid formulations.
(7) The BUD shall not exceed the expiration date
of the API or any other component.
(h) The compounder shall ensure that the
containers and closures used in packaging compounded preparations meet the
following USP requirements:
(1) The containers and closures shall be made of
clean material in order not to alter the quality, strength, or purity of the
compounded preparation;
(2) Container-drug interaction shall be
considered for substances that have sorptive or leaching properties; and
(3) Containers and
closures shall be handled and stored in such a way as to prevent contamination.
(i)
Compounders shall comply with the following requirements regarding compound
documentation;
(1) Documentation, written or electronic, shall
be kept for 4 years;
(2) Documentation shall comply with state and
federal laws;
(3) Documentation shall not be required when preparing
a compounded preparation according to the manufacturer’s labeled instructions;
(4) The record may be a copy of the prescription
in written or machine-readable form and shall include a master formula record
and a compound record;
(5) Information contained in the master
formulation record shall include the
following:
a. Official or assigned name, strength, and
dosage form of the preparation;
b. Calculations needed to determine and verify
quantities of components and doses of active pharmaceutical ingredients;
c. Description of all ingredients and their
quantities;
d. Compatibility and stability information,
including references when available;
e. Equipment needed;
f. Mixing instructions;
g. Order of mixing;
h. Mixing temperature or other controls;
i. Duration of mixing;
j. Any other pertinent instruction;
k. Labeling information in addition to legally
required information found in RSA 318:47-a including:
1. Name and quantity or concentration of each
active ingredient;
2. Assigned BUD;
3. Storage conditions; and
4. Prescription number;
l. Container used in dispensing;
m. Packaging and storage requirements;
n. Description of final preparation; and
o. Quality control procedures and expected
results; and
(6) The compound record shall contain at least
the following:
a. Official or assigned name, strength, and
dosage of the preparation;
b. Master formulation record reference for the
preparation;
c. Names and quantities of all components;
d. Sources, lot numbers, and expiration dates of
components;
e. Total quantity compounded;
f. Name of the person who prepared the compound,
who performed the quality control procedures, and approved the preparation;
g. Date of the preparation;
h. Assigned controlled or prescription number;
i. Assigned BUD;
j. Description of final preparation;
k. Results of quality control procedures such as
weight range of filled capsules, pH record; and
l. Documentation of any QC issues and any ADRs
reported by patient or caregiver;
(j)
All significant procedures performed in the compounding area shall be
covered by written standard operating procedures (SOPs) including:
(1) Facility maintenance, workflow, and cleaning;
(2) Equipment use and maintenance;
(3) Personnel;
(4) Training;
(5) Preparation;
(6) Packaging;
(7) Storage of compounded preparations;
(8) Quality assurance;
(9) Safety;
(10) Uniformity;
(11) Continuous quality improvement; and
(12) Maintain updated SDS library.
(k)
The compounder shall perform the following to ensure quality control;
(1) Review calculation, ingredients, measurements
and procedures; and
(2) Observe the finished preparation to ensure
that it appears as expected and investigate any discrepancies and take
appropriate corrective action before the prescription is dispensed to the
patient.
(l)
The compounder shall ensure the following compounding controls are
followed:
(1) There are written procedures for the
compounding of drug preparations to ensure that the finished preparations have
the identity, strength, quality, and purity that they purport to have. These
procedures shall be available in either written form or electronically stored;
(2) The written procedures shall be followed in
execution of the compounding process;
(3) Check and document each weight and
measurement;
(4) Document the identity of the person(s)
actually performing the compounding;
(5) Document the name of compounder;
(6) Establish written procedures that will
describe quality assurance tests or examinations to be conducted on the
compounded preparation to ensure uniformity and integrity;
(7) To monitor the output and to validate the
performance of those compounding processes and equipment that could be
responsible for causing variability in the final compounded preparation; and
(8) Records shall be maintained with compounding
records for 10 years.
(m)
At the time of dispensing, the patient or the patient’s agent shall be
counseled about proper use, storage, handling, and disposal of the compounded
preparation. The patient or the
patient’s agent shall also be instructed to observe and report to the
compounder any changes in the physical characteristics of the compounded
preparation. Counseling may be in written, oral, electronic, or other
formats. The compounding pharmacist
shall investigate any reported problem with a compounded preparation and take
corrective action.
(n)
It shall be the responsibility of the compounder to ensure that a training
program has been implemented and that it is ongoing. Compounding personnel
shall be trained initially and the training shall be documented.
(o)
Steps in the training procedure shall include the following:
(1) All employees involved in pharmaceutical
compounding shall read and become familiar with USP Chapter 795. They shall also be familiar with other
relevant publications including how to read and interpret SDSs;
(2) All employees
shall read and become familiar with each of the procedures related to
compounding including those involving the facility, equipment, personnel,
actual compounding, evaluation, packaging, storage and dispensing;
(3) All personnel who compound hazardous drugs
shall be fully trained in the storage, handling and disposal of these
drugs. This training shall occur before
preparing or handling hazardous drugs;
(4) All training activities shall be
documented. The compounder shall meet
with employees to review their work and answer any questions the employee may
have concerning compounding procedures;
(5) The compounder shall demonstrate the
procedures for the employee and shall observe and guide the employee throughout
the training process. The employee shall
then repeat the procedure without any assistance from, but under the
supervision of the compounder;
(6) When the employee has demonstrated to the
compounder a verbal and functional knowledge of the procedure, then and only
then shall the employee be permitted to perform the procedure without direct
supervision. However the compounder
shall be physically present and shall approve all ingredients and their
quantities and the final preparation;
(7) When the
compounder is satisfied with the employee’s knowledge and proficiency, the
compounder shall sign the documentation records to show that the employee was
appropriately trained;
(8) The compounder shall continually monitor the work
of the employee and ensure that the employee’s calculations and work are
accurate and adequately performed; and
(9) The compounder shall be solely responsible
for the finished preparation.
(p)
The following requirements shall be met when compounding for animal
patients:
(1) Intended use on any animal patient, such as
companion, performance or food, shall be determined before compounding for that
patient. Because humans can consume
animals as food, care shall be taken to prevent drug residue from entering the
human food chain;
(2) Compounders who compound for animals shall
possess knowledge of drug regulation, uses, dosing and disposition in animal patients to
properly determine appropriateness of therapy; and
(3) The
compounding pharmacist shall be knowledgeable about the individual species
limitations in physiology and metabolic capacity that can result in toxicity
when certain drugs or excipients are used in compounded preparations. For this reason, pharmacists compounding for
animals shall use when possible, formulations developed specifically for animal
patients. If such formulations are not
available, the compounding pharmacist shall conduct a literature review to
determine whether a specific component of the formula is toxic to the target
species. Compounded preparations shall
not to be dispensed or sold to veterinary offices for resale.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.04 Regulatory Requirements for Sterile
Compounding.
(a) A compounder shall have and maintain
a permit issued by the board that allows for the compounding of sterile
products as defined by the board.
(b)
When a compounder prepares more than 50 dosage units for non-patient
specific preparations the compounder shall be registered as a drug manufacturer
or 503B with the FDA.
(c) Compounders supplying limited
quantities, less than 50 dosage units, to providers for administration use
shall have an MOU with the provider for each compounded product they supply to
the provider. When a compounder provides
a practitioner a non-patient specific preparation, the compounder shall provide
the practitioner a copy of the test result for each lot provided to the
practitioner.
(d) Each batch of a high risk CSP shall be assigned a unique lot number
and shall be tested by an independent lab for sterility, potency, and
endotoxins. Only a batch that has passed
all 3 tests shall be made available to provide to a hospital or practitioner.
(e)
A compounder shall not compound a sterile product of an FDA-approved
product when the product is commercially available.
(f) When no commercial source of a sterile
product exists, such as being listed on the FDA backorder list, the compounder
shall only use USP or other USP recognized grades such as BP, JP, EP,
bulk ingredients obtained from a good manufacturing practice
compliant supplier. The compounder shall
obtain and keep on file for at least 3 years a certificate of analysis and
potency testing of all bulk ingredients used to compound each and every compounded
product made with a bulk, non-sterile ingredient.
(g)
A compounder who uses hazardous products shall meet state and federal
requirements for handling of hazardous agents.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.05 Sterile Quality Requirements.
(a)
Each compounder shall maintain documentation that confirms staff
training and competency related to proper garbing and hand hygiene, aseptic
technique and related practices, and cleaning and disinfection procedures prior
to compounding of any actual sterile product preparation.
(b)
Each compounder shall maintain documentation that confirms that the
compounder tests aseptic techniques of all staff that compounds sterile
products by preparing media fill units per USP standards.
(c)
Each compounder shall maintain documentation that confirms all staff
that compounds sterile products are pre-qualified using media fills before
compounding of actual drug preparations.
(d)
When a positive media fill occurs, compounder shall perform a
comprehensive investigation to identify root cause, and document the
finding.
(e)
When a positive media fill occurs, compounder shall institute corrective
and preventive action, and document the corrective action.
(f)
Each compounder shall verify that all personnel who compound sterile
products are complying with gowning, gloving, and glove-tip processes
consistent with USP standards by meeting the following requirements:
(1) Three glove
fingertip tests shall be performed initially then annually for low and medium risk compounding;
(2) Three glove
fingertip tests shall be performed initially then every 6 months for high risk
compounding; and
(3) Media fill tests shall be performed every 6
months for high risk compounding.
(g) Each compounder shall perform
routine surface microbiological and fungal environmental monitoring to minimize
contamination at least every 6 months, or in accordance with facilities
policies.
(h) Each compounder shall perform
comprehensive investigations of out-of-limit findings, as recommended by USP
standards to determine root cause, followed by corrective and preventative
actions at least weekly. Each compounder shall maintain all documentation of
its findings.
(i) Each compounder shall perform, at
least semi-annually, viable particle testing in primary engineering controls,
such as laminar flow workbench, biological safety cabinet and room air
according to USP standards.
(j)
Each compounder shall ensure that all compounded sterile products that
require refrigeration are stored in appropriate refrigeration at all times.
(k)
When a compounder assigns a BUD for a sterile product that exceeds BUD
limits established in USP standards, a compounder shall have laboratory testing
results that support extended expiration dating for compounded sterile
preparations to any patient or organization that request such
documentation.
(l)
Each compounder shall perform studies to determine extended expiration
dates, using evidence-based and validated stability testing procedures, for
compounded sterile preparations for which no extended expiration evidence
exists.
(m)
Each compounder shall have a policy that requires validation of new or
changed facilities, equipment, processes, container types, for sterility, and
repeatability.
(n) Each compounder shall have a
quality assurance program to promptly address equipment problems.
(o)
Each compounder shall have a quality assurance program for compounding
that includes at least the following separate, but integrated, components:
(1) Training;
(2) Standard operating procedures;
(3) Documentation;
(4) Verification;
(5) Testing;
(6) Cleaning and disinfecting;
(7) Containers, packaging and repackaging; and
(8) Storage.
(p)
Personnel involved in the compounding, evaluation, packaging and
dispensing of compounded preparations shall be properly trained and evaluated
to include:
(1) Three glove
fingertip tests shall be performed initially then annually for low and medium risk compounding; and
(2) Three glove fingertip tests shall be
performed initially then every 6 months for high risk compounding.
(q)
Personnel shall undergo re-qualification using media fills and glove fingertip tests annually for low
and medium risk sterile compounding and every 6 months thereafter for high risk
sterile compounding.
(r)
Each compounder shall have an action plan and alert limits for
environmental monitoring.
(s)
Each compounder shall develop and implement methods for improving
quality based on analyzed data found in its environmental monitoring.
(t)
Each compounder shall evaluate and continuously monitor the methods used
for the packaging, handling, and transport of CSPs.
(u) Each compounder shall evaluate and
continuously monitor the storage of CSPs to ensure compliance with appropriate
storage conditions.
(v)
Each compounder shall ensure drug storage refrigerators, freezers and
medication storage areas have daily monitoring and documentation of
temperatures.
(w) Compounder personnel shall inspect all drug
storage areas routinely to ensure drugs are stored separately from food.
(x)
Each compounder shall ensure all solutions, medications, equipment, and
supplies located in all areas are stored according to the manufacturer or USP
requirements and are inspected monthly for proper conditions of light,
temperature, moisture, and ventilation.
(y)
Each compounder shall ensure all outdated and unused CSPs are segregated
in a separate area for return and disposal.
(z) Each compounder shall ensure only
pharmacists training in sterile compounding determine whether a CSP not
administered as originally intended can be used for an alternate patient or
under alternate conditions.
(aa)
Each compounder shall have an environmental sampling plan based on the
compounding activities performed, locations to be monitored, the device used to
monitor, the frequency of collection, and procedures if readings exceed
established thresholds.
(ab)
The 2 types of monitoring that shall be used are:
(1) Non-viable monitoring which includes particle
counts, monitoring pressure or velocity difference between the buffer area,
ante area and non-classified area and shall be done at least every 6 months;
and
(2) Viable monitoring which detects microbial or
fungal contaminants in the compounding area and shall be done using a
volumetric collection method.
(ac)
Monitoring, sampling, and testing for surface contamination from
hazardous drugs is conducted at least every month or earlier in cases of
contamination from fluid or solid dosage form spills.
(ad) Compounder shall ensure
certification of its PEC complies with the requirements of USP Standards. Certification shall be done by an independent
entity certified to perform the test.
Each certifying entity shall leave a signed copy of the test with the
compounder who shall retain the document for at least 4 years.
(ae)
Each compounder shall ensure the PEC is certified every 6 months or
sooner if recommended by the manufacturer.
(af)
Each compounder shall ensure viable and non-viable airborne sampling
occurs minimally every 6 months.
Monitoring shall include all areas at risk of contamination including
but not limited to inside of PEC, counters, anteroom, areas near doorways, and
any pass-through, counters, storage areas, shelves, shipping and receiving
areas, and employee work areas.
(ag) Each compounder shall ensure
sampling data is base-lined, evaluated and documented on a routine basis as
defined by USP standards.
(ah)
Each compounder shall have a written plan and schedule for environmental
monitoring.
(ai)
Each compounder shall have a written environmental plan that adequately
evaluates the various controlled air environment areas including the PEC,
buffer area, and anteroom.
(aj) Compounder facility personnel, or
external personnel, who complete the environmental monitoring shall be
appropriately trained and certified by a national certification entity.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.06 Compounding Environment.
(a)
Each compounder shall ensure there is sufficient space for the type and
amount of compounding done.
(b)
Each compounder shall ensure there is appropriate space for orderly
placement of equipment and materials to prevent mix-ups between ingredients,
containers, labels, in-process materials and finished preparations.
(c)
Each compounder shall ensure it has procedures to prevent
cross-contamination.
(d)
Each compounder shall ensure areas used for sterile preparation are
separate and distinct from areas used for non-sterile preparation.
(e)
Each compounder shall have a well-lighted compounding environment.
(f)
Each compounder shall ensure all heating, ventilation and air
conditioning systems are controlled to maintain a constant temperature 24 hours
per day, 7 days per week.
(g)
Each compounder shall maintain a bulk storage area that is adequately
arranged and proper temperature and humidity maintained.
(h)
Each compounder shall supply hot and cold potable water for hand and
equipment washing in the compounding area, and soap or detergent and single-use
towels or driers shall be readily available.
(i)
Each compounder shall ensure all compounding areas are maintained in a
clean and sanitary condition.
(j)
When compounder uses hard-wall construction, the finished surface shall
provide a non-porous, durable and washable surface.
(k)
The compound area shall meet the following requirements:
(1) All ceilings shall be smooth, impervious, free
from cracks and non-shedding, such as plastic covered clean room grade ceiling
tiles, and all tiles shall be sealed;
(2) All floors
shall be smooth, impervious, free from cracks and non-shedding, and the floor
must be of seamless vinyl;
(3) All fixtures
shall be smooth, impervious, free from cracks and non-shedding. All fixtures shall be mounted to wall in a
way that seals any space between wall and fixture;
(4) All shelving shall be smooth, impervious,
free from cracks and non-shedding;
(5) Counters shall be smooth, impervious, free
from cracks and non-shedding;
(6) All cabinets shall be smooth, impervious,
free from cracks and non-shedding;
(7) Ceiling to wall junctures shall be covered or
caulked to avoid cracks;
(8) Inlaid ceiling panels shall be impervious and
hydrophobic;
(9) Ceiling panels shall be caulked around the
perimeter to seal them to frame;
(10) Floors shall be overlaid with wide sheet
vinyl flooring with heat welded seams and coving to the sidewall;
(11) There shall be no dust-collecting overhangs;
(12) There shall be no windowsills;
(13) Exterior lens surface of ceiling light
fixtures shall be smooth, mounted flush, and sealed;
(14) There shall be no sinks in primary and
secondary compounding areas;
(15) There shall be no floor drains in primary and
secondary compounding areas;
(16) Carts shall be made of stainless steel wire
or sheet metal with cleanable casters;
(17) Carts
shall be mobile;
(18) All surfaces shall be designed to provide
effective cleaning;
(19) All surfaces shall be resistant to damage by
cleaning agents;
(20) There shall be no cardboard containers in
buffer area at any time;
(21) There shall be no computers, printers, radios
and refrigerators in the buffer area at any time;
(22) The bulk storage area shall be maintained in
a clean and sanitary condition;
(23) Trash shall be disposed of in a safe,
sanitary and timely manner; and
(24) All components, containers and equipment
shall be stored off the floor in a manner to prevent contamination and permit
inspection and cleaning of the compounding and storage area.
(l)
Each compounder shall ensure equipment is of appropriate design and size
for the compounding that is performed.
(m)
Each compounder shall ensure that all equipment is of appropriate design
such that the surface that contact pharmaceutical components, in-process
materials or finished preparations is not reactive, additive or adsorptive.
(n)
Each compounder shall ensure that all equipment is thoroughly cleaned
immediately after use to avoid cross-contamination.
(o)
Each compounder shall ensure
all equipment is stored to prevent it from contamination and is located to
facilitate its use, maintenance, and cleaning.
(p)
Each compounder shall ensure
all equipment used for allergenic ingredients is appropriately handled, cleaned
and stored immediately after use.
(q)
Each compounder shall ensure
all work surfaces are cleaned of loose materials and residue from spills before
compounding.
(r)
Each compounder shall ensure
all floors in the buffer area and ante area are mopped daily with a cleaning
and disinfecting agent at a time when no aseptic compounding is in progress.
(s)
Each compounder shall approve
all cleansing and sanitizing agents considering compatibilities, effectiveness,
and presence of inappropriate or toxic residues.
(t)
Each compounder shall ensure the following requirements are met:
(1) Mops, wipes, sponges, and other cleaning
materials shall be non-shedding and dedicated for use only in the sterile
compounding area;
(2) Cleaning tools shall be replaced as soon as
they are identified as unsuitable for use;
(3) All cleaning materials shall be disposable
and discarded after one use;
(4) All trash
shall be collected in suitable plastic bags and removed on a daily basis with
minimal agitation;
(5) Workspaces shall be cleaned and sanitized
daily including all buffer room carts,
equipment, workbenches, work surfaces, and floors, and document the activity;
(6) Storage shelving in buffer and ante areas
shall be emptied of all supplies, cleaned, and sanitized at planned intervals
at least monthly;
(7) Walls and ceilings in buffer and ante areas
shall be cleaned at least monthly; and
(8) All equipment shall be clean, properly
maintained, validated and documented at appropriate intervals as defined by USP
Standards.
Source. #6181-B, eff 2-5-96,
EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.07 Engineering Controls.
(a)
Each compounder shall ensure the PEC, LAFW and BSCs provide ISO Class 5
air quality;
(b)
Each compounder shall ensure
the buffer room maintains a minimum of an
ISO Class 7 air quality;
(c)
Each compounder shall ensure the
buffer room is designed to reduce the risk of contaminants being blown into the
primary compounding area, or
PCA. To be considered a clean room,
buffer area must meet specific air quality, HEPA filtration, air changes per
hour, and room pressure differentiation criteria to provide at least ISO Class
7 air quality.
(d)
Each compounder shall ensure
that within the buffer area, the PEC should be kept away from excess traffic,
doors, air vents, or anything that could introduce contaminates into the
workbench.
(e)
Each compounder shall ensure
that the anteroom is separate from buffer area.
(f)
Each compounder shall ensure
that the anteroom provides ISO Class 8 air quality, or ISO Class 7 air quality,
depending on the connecting buffer area.
(g)
Each compounder shall ensure
the anteroom area should store an adequate amount of gowning supplies but should
not be part of high traffic area or corridor.
(h)
Each compounder shall ensure
the anteroom is used to un-carton and sanitize all supplies to be taken into
buffer area.
(i)
Each compounder shall ensure sure the anteroom contains:
(1) Hand sanitizing equipment;
(2) Proper gowning equipment and space to
accommodate gowning activities;
(3) Faucet handles that shall be designed to be
hands-free; and
(4) That the
buffer area can be accessed without the use of hands.
(j)
Each compounder that only
compounds low and/or medium risk preparations, the ante room may be in the same
area as the buffer room, separated by a line of demarcation. However, a separate ante room shall be the
preferred method.
(k)
Each compounder that
compounds high risk preparations, the buffer room and the ante room shall be 2
separate rooms.
(l)
Each compounder shall ensure
all supplies brought into the buffer area are non-permeable, non-shedding, and
resistant to disinfectants.
(m)
Each compounder shall ensure
all materials exposed to patient care areas are kept out of the buffer area.
(n)
Each compounder shall ensure
the PECs are cleaned and disinfected at the beginning of each shift, before
each batch, at least every 30 minutes during compounding, when surfaces are
visibly soiled, and when surface contamination is known or even suspected.
(o)
Each compounder shall ensure all interior working surfaces are cleaned
and disinfected of LAFW from top to bottom, back to front, away from the HEPA
filter. Cleaning shall be performed with
purified water, and disinfecting with sterile 70% isopropyl alcohol or similar
antimicrobial, residue-free sanitizing agent.
(p)
Each compounder shall ensure
nothing shall be permitted to come in contact with the HEPA filter. This includes cleaning solutions, aspirate
from syringes, or glass from ampules, which shall not be broken towards the
filter.
(q)
Each compounder shall ensure air
exchange with the surrounding environment shall not occur unless the air is
first passed through a microbial retentive filter such as a HEPA system capable
of containing airborne concentrations of the physical size and state of the
drug being compounded. Where volatile
hazardous drugs are prepared, the exhaust air from the isolator shall be
appropriately removed by properly designed building ventilation.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
New. #10812, eff 4-18-15
Ph 404.08 Compounding Procedures.
(a)
Each compounder shall ensure
that all personnel adhere to the following when they are in the LAFW or buffer
areas:
(1) No smoking, food, drink, or chewing gum shall
be allowed in the buffer area at any
time;
(2) No jewelry shall be worn on the hands or wrists and
there shall be no visible piercings;
(3) No make-up shall be worn in the buffer area as it can shed particles;
(4) Before putting on gloves, the nails shall be
cleaned, and the hands, wrists, and forearms shall be washed thoroughly for at
least 30 seconds with warm water and antimicrobial skin cleanser;
(5) Personnel shall appropriately utilize gowns,
masks, gloves, hair covers, and shoe covers;
(6) No paper, pens, labels, or trays shall be placed in the workbench; and
(7) No objects that shed particles shall be brought into the buffer area such
as cardboard cartons, paper towels, and cotton items.
(b)
Each compounder shall ensure when cleaning and disinfecting the interior
work surfaces of the LAFW it is done from top to bottom, back to front, away
for the HEPA filter.
(c)
Each compounder shall ensure personnel check the quality, purity,
amount, and identity of all ingredients.
(d)
Each compounder shall ensure all personnel use the correct compounding
procedures when compounding sterile products, and periodically disinfect gloves
with sterile 70% isopropyl alcohol and allow them to dry thoroughly before
continuing.
(e)
Each compounder shall ensure that open and partially used containers are
properly labeled and stored.
(f)
Each compounder shall ensure
the following:
(1) CSP has an appropriate BUD that is identified on all product
labels;
(2) When the BUD exceeds USP standards, it is
based on scientific criteria;
(3) Packaging is appropriate for sterility and
stability;
(4) Product labels are appropriate and complete
for safe use; and
(5) Products are visually inspected for physical
integrity during and after compounding, and a final check of the CSP is
performed.
(g)
Each compounder shall ensure
any deficiencies in compounding procedures can be rapidly identified and
corrected.
(h)
Each compounder shall ensure that finished compounded products are
maintained in a separate area away from the active compounding area, and that
no more than 2 entries into any one sterile container or sterile administration
device.
(i)
Each compounder shall ensure
all compounding activity only involves closed or sealed packaging systems.
(j)
In the absence of stability and sterility testing of any CSP the
compounder shall use BUD based on USP standards as defined for the following
CSPs:
(1) Low risk compounded product storage shall not
exceed 48 hours at room temperature, 14 days at cold temperature or 45 days in
a frozen state if the stability of the product allows;
(2) Medium risk compounded product storage shall
not exceed 30 hours at controlled room temperature, 9 days at cold temperature or 45 days in a
frozen state;
(3) High risk compounded product storage shall not exceed 24 hours at
room temperature, 3 days at cold
temperature or 45 days in a frozen state.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.09 Records Management.
(a)
Compounder shall maintain the following records related to compounding
of sterile products for at least 4 years:
(1) PEC certification records;
(2) GAP analyses; and
(3) Detailed formulation record of each sterile
compounded preparation that includes:
a. Name of preparation, strength and dosage
form;
b. All ingredients and their quantities;
c. Equipment used for the preparation;
d. Add mixing instructions to include order of
mixing, temperatures, duration of mixing and other pertinent factors;
e. Assigned beyond-use date;
f. Container used;
g. Storage requirements; and
h. Quality control procedures.
(b)
Each compounder shall have
procedures developed for the facility, equipment, personnel, preparation,
packaging and storage of compounded preparation to ensure accountability,
accuracy, quality, safety, and uniformity in compounding.
(c)
Each compounder shall have a procedure for recalls. The recall file shall be maintained with
information concerning any applicable recalled products affecting the pharmacy.
(d)
Each compounder shall perform
and maintain a quality control history and quality assurance trend reports on a
quarterly basis and upon request.
(e)
Each compounder shall
maintain documentation that confirms that sterile media used is certified by
the manufacturer to be sterile and guaranteed to promote growth.
(f)
Each compounder shall
maintain detailed reports on the incidence of positive media test results and
the follow-up retests after corrective action is completed.
(g)
Each compounder shall provide
a guaranteed shelf life upon delivery. This date shall be based on USP
Standards, or based on established scientific criteria.
(h)
Each compounder shall
document processes and procedures including shipping validation studies to
ensure that preparations leaving the site retain their integrity and stability
through the shipping cycle.
(i)
Each compounder shall ensure
that all personnel annually receive live training and visual process validation
including written documentation of both processes.
(j)
Each compounder shall
maintain documentation that it’s cleaning methods and agents are effective in
preventing contamination of the sterile preparations area.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 405 STANDARDS OF PRACTICE FOR NUCLEAR/RADIOLOGIC
PHARMACY
Ph 405.01 Purpose. The practice of nuclear pharmacy is hereby recognized
as a specialty of pharmacy practice, regulated by the state board of
pharmacy. As such, the following rules
are included to address those areas specific or unique to this specialty
practice.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.02 Definitions.
(a)
"Authentication of product history" means identifying the
purchasing source, the ultimate fate, and any intermediate handling of any
component of a radiopharmaceutical or other drug.
(b)
"Nuclear pharmacy" means a pharmacy which provides
radiopharmaceutical services.
(c) "Practice of nuclear
pharmacy" means a patient-oriented service that embodies the scientific
knowledge and professional judgment required to improve and promote health
through the assurance of the safe and efficacious use of radiopharmaceuticals
and other drugs.
(d)
"Quality assurance procedures" means all activities necessary
to guarantee the integrity of the process used to provide radiopharmaceutical
services, including authentication of product history and maintenance of all
records as required by the department of health and human services, bureau of
radiological health.
(e)
"Quality control testing" means the performance of chemical,
biological and physical tests on compounded radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in
humans and animals.
(f)
"Radiopharmaceutical" means any drug which exhibits
spontaneous disintegration of unstable nuclei with the emission of nuclear
particles or photons. The term includes
any nonradioactive reagent kit or nuclide generator which is intended to be
used in the preparation of any such substance, but does not include drugs such
as carbon-containing compounds or potassium-containing salts which contain
trace quantities of naturally occurring radionuclides. The term also includes any biological product
which is labeled with a radionuclide or intended solely to be labeled with a
radionuclide.
(g) "Radiopharmaceutical
service" means the procurement, storage, handling, compounding, preparation,
labeling, quality control testing, dispensing, distribution, transfer, record
keeping and disposal of radiochemicals, radiopharmaceuticals and ancillary
drugs.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.03 General Requirements for Pharmacies
Providing Radiopharmaceutical Services.
(a)
A permit to operate a pharmacy which provides radiopharmaceutical
services shall only be issued to a person who is, or who employs, a qualified
nuclear pharmacist. All personnel
performing tasks in the preparation and distribution of radiopharmaceuticals
and ancillary drugs shall be under the direct supervision of a qualified nuclear
pharmacist, who shall be in personal attendance when the pharmacy is open for
business. The pharmacist-in-charge shall
be responsible for all operations of the pharmacy.
(b)
The nuclear pharmacist who licenses the pharmacy shall hold a current
license issued by the board, and be either certified as a nuclear pharmacist by
the board of pharmaceutical specialties or satisfy each of the following
requirements:
(1) Meets minimal standards of training for
status as authorized user of radioactive material, as specified by the
department of health and human services, bureau of radiological health;
(2) Has
successfully completed a minimum of 200 contact hours of instruction in nuclear
pharmacy and the safe handling and use of radioactive materials from a nationally
accredited college of pharmacy, or other training program recognized by the
department of health and human services, bureau of radiological health;
(3) The 200 hours of instruction referenced in
(2) above shall be apportioned as follows:
a. Radiation physics and instrumentation, 85
hours;
b. Radiation protection, 45 hours;
c. Mathematics pertaining to the use and
measurement of radioactivity, 20 hours;
d. Radiation biology, 20 hours; and
e. Radiopharmaceutical chemistry, 30 hours;
(4) Has attained a minimum of 500 hours of
clinical/practical nuclear pharmacy training under the supervision of a
qualified nuclear pharmacist in, but not limited to, the following areas:
a. Procuring radioactive materials;
b. Compounding radiopharmaceuticals;
c. Performing routine quality control
procedures;
d. Dispensing radiopharmaceuticals;
e. Distributing radiopharmaceuticals;
f. Implementing basic radiation protection
procedures; and
g. Consulting and educating the nuclear medicine
community, patients, pharmacists, other health professionals, and the general
public; and
(5) Has submitted an affidavit of experience and
training to the board.
(c)
The permit to operate a nuclear pharmacy shall be effective only so long
as the pharmacy also holds a current license issued by the department of health
and human services, bureau of radiological health. Copies of the bureau of radiological health
inspection reports shall be available at the pharmacy for board inspection.
(d)
Nuclear pharmacies shall have adequate space and equipment, commensurate
with the scope of services required and provided and meeting minimal space
requirements established for all pharmacies in the state.
(e)
All pharmacies handling radiopharmaceuticals shall include, but not be
limited to, the following areas:
(1) Radiopharmaceutical preparation/dispensing
area;
(2) Radioactive material shipping/receiving area;
(3) Radioactive material storage area; and
(4) Radioactive waste decay area.
(f)
The application for a permit to operate a nuclear pharmacy shall be the
same as in Ph 304.01 and Ph 304.02.
(g)
The nuclear pharmacy professional service area shall be secured from
unauthorized personnel and shall be totally enclosed and lockable.
(h)
Nuclear pharmacies shall maintain records of acquisition, inventory and
disposition of all radioactive drugs and other radioactive materials in
accordance with the board and the department of health and human services,
bureau of radiological health statutes and rules.
(i)
A radiopharmaceutical shall be dispensed only to a licensed practitioner
authorized by the department of health and human services, bureau of
radiological health to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only
upon receipt of a prescription or medication order from such licensed
practitioner. Otherwise, a
radiopharmaceutical may be transferred to a person who is authorized to possess
and use such drug for non-clinical applications.
(j)
A nuclear pharmacy, upon receiving an oral prescription order for a
radiopharmaceutical, shall immediately have the prescription order reduced to
writing, or recorded in a data processing system.
(k)
The writing or record required by (i) above shall contain at least the
following:
(1) The name of the institution and prescriber,
or prescribers' agent;
(2) The date of dispensing and the calibration
time of the radiopharmaceutical;
(3) The name of the procedure;
(4) The name of the radiopharmaceutical;
(5) The dose or quantity of the
radiopharmaceutical;
(6) The serial number assigned to the order for
the radiopharmaceutical;
(7) Any specific instructions;
(8) The initials of the person who received the
order; and
(9) The initials of the person who dispensed the
order.
(l)
Whenever an order is for a therapeutic or blood‑product
radiopharmaceutical, the patient's name shall be obtained and recorded prior to
dispensing.
(m)
The immediate outer container shield of a radiopharmaceutical to be
dispensed shall be labeled with:
(1) The name and address of the pharmacy;
(2) The name of the prescriber;
(3) The date of dispensing;
(4) The serial number assigned to the order for
the radiopharmaceutical;
(5) The standard radiation symbol;
(6) The words "Caution Radioactive
Material";
(7) The name of the procedure;
(8) The radionuclide and chemical form;
(9) The amount of radioactivity and the
calibration date and time;
(10) If a liquid, the volume;
(11) If a solid, the number of items or weight;
(12) If a gas, the number of ampules or vials;
(13) Molybdenum 99 content to USP limits; and
(14) The name of the patient or the words
"Physician's Use Only" in the absence of a patient name.
(n)
When the prescription is for a therapeutic or blood-product
radiopharmaceutical, the patient name shall appear on the label. The requirements of this paragraph shall be
met when the name of the patient is readily retrievable from the physician upon
demand.
(o)
The immediate inner container label of a radiopharmaceutical to be
dispensed shall be labeled with:
(1) The name of the pharmacy;
(2) The standard radiation symbol;
(3) The words "Caution Radioactive
Material";
(4) The identity of the radionuclide;
(5) The chemical form;
(6) The name of the procedure; and
(7) Serial number of the radiopharmaceutical.
(p)
When a radiopharmaceutical is dispensed under the authority of an
investigational new drug application (
(q)
Each nuclear pharmacy shall have a current copy of the United States
Pharmacopeia/National Formulary (USP/NF), USP-DI, and a current copy of state
and federal rules and regulations governing the safe storage, handling, use,
dispensing, transport and disposal of radiopharmaceuticals.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.04 Minimum Equipment. The pharmacy shall have at least the
following equipment:
(a)
A radionuclide dose calibrator;
(b)
A refrigerator;
(c)
A single or multiple channel scintillation counter with well-type NaI
(Tl) or Ge (Li) detector;
(d)
A radiochemical fume hood and filter system with air sampling equipment;
(e)
An area survey meter;
(f)
At least 2 Geiger Mueller survey meters including one high-range meter;
(g)
A microscope and hemacytometer;
(h) A laminar air flow hood and appropriate
supplies to ensure sterile practices for parenteral solutions;
(i)
Syringe and vial radiation shields;
(j)
A lead‑shielded drawing station;
(k)
Decontamination supplies;
(l)
Supplies to perform quality assurance testing;
(m)
Lead transport shields for syringes and vials; and
(n)
United States Department of
Transportation approved USA Type A ‑ 7A transport containers and other
labels and supplies for shipping radioactive materials.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
CHAPTER Ph
500 ETHICAL STANDARDS
PART Ph 501 CODE OF ETHICS
Ph 501.01 Standards of Conduct.
(a)
The ethical standards set forth in this part shall bind all licensees,
and violation of any such standard shall be a basis for the imposition of
disciplinary sanctions.
(b)
A licensed pharmacist shall:
(1) Hold the health and safety of patients to be
of first consideration and render to each patient the full measure of his/her
ability as an essential health practitioner;
(2) Never condone the dispensing, promoting or
distributing of drugs or medical devices, or assist therein, which are not of
good quality, which do not meet standards required by law or which lack
therapeutic value for the patient;
(3) Always strive to perfect and enlarge his/her
professional knowledge;
(4) Utilize and make available his/her knowledge
as might be required in accordance with his/her best professional judgment;
(5) Observe the law, uphold the dignity and honor
of the profession, and accept its ethical principles;
(6) Not engage in any activity that will bring
discredit to the profession and shall expose, without fear or favor, illegal or
unethical conduct in the profession;
(7) Seek at all times only fair and reasonable
remuneration for services rendered;
(8) Never agree to or participate in transactions
with practitioners of other health professions or any other person under which
fees are divided or which might cause financial or other exploitation in
connection with the rendering of their professional services;
(9) Respect the confidential and personal nature
of professional records, except in emergency situations where the best interest
of the patient requires or the law demands, and shall not disclose such
information to anyone without patient authorization;
(10) Not agree to practice under terms or
conditions which tend to interfere with or impair the proper exercise of
professional judgment and skill, which could cause a deterioration of the
quality of his/her service or which require him/her to consent to unethical
conduct;
(11) Refrain from advertising professional
services in a manner which is misleading to the public or which conveys by
implication that the services of fellow pharmacists are unethical or inferior;
(12) Maintain a sanitary and orderly prescription
department which is fully equipped and stocked to meet the needs of the
community; and
(13) Fulfill all professional obligations
conscientiously and with due respect for the physical and well-being of the
community, and, uphold at all times the standards of the profession of
pharmacy.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10455, eff 11-1-13
CHAPTER Ph
600 LIMITED RETAIL DRUG DISTRIBUTOR
Statutory Authority: RSA 318:51-b
PART Ph 601 LICENSING OF LIMITED
RETAIL DRUG DISTRIBUTORS
Ph 601.01 License Required.
(a) No person
shall act as a limited retail drug distributor, as defined in RSA 318:1,VII-a,
without first obtaining a
license to do so from the board according to RSA 318:51-b.
(b) No
license shall be issued or renewed for a limited retail drug distributor unless
the same shall be operated in a manner prescribed by RSA 318:51-b and according
to Ph 600.
(c) Separate licenses shall be required for each
site owned and operated by the limited retail drug distributor.
(d) The board shall provide, on a biennial basis,
a license renewal application to all licensed limited retail drug
distributors. The biennial license shall
expire on June 30th of every odd-numbered year. Licensees shall file the renewal application
and pay the fee in (e) below by June 15th of every odd-numbered
year.
(e) The
prescribed fee for initial and biennial renewal licenses for limited retail
drug distributors shall be:
(1) For clinics under contract
with the department of health and human services (DHHS), $300;
(2) For methadone
maintenance/detoxification treatment centers, $500; and
(3) For medical gas suppliers,
$300.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #8572, eff 2-23-06; amd by #9139-B, eff
4-25-08; paragraphs (a)-(d) EXPIRED:
2-23-14; paragraph (e) EXPIRED: 4-25-16
New. #12335, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 601.02 Obtaining and Filing a License Application.
(a) Applications for licensure of limited retail drug
distributors may be obtained from and filed at the board office, identified in
Ph 103.03.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.03 Application Contents.
(a) The applicant for licensure shall complete
and submit a “Limited Retail Drug Distributor of Medical Gases and/or Medical
Devices” form, form MM-1, revised June 2017.
(b) The applicant shall also submit the
following:
(1) A scaled drawing of the
facility;
(2) A copy of the state license
from the state licensing agency where the facility is located, if such facility
is outside New Hampshire, or an explanation detailing why the applicant does
not have such a license; and
(3) A copy of the facility’s most
recent inspection report completed by the state licensing board or agency where
the facility is domiciled, if it is located outside New Hampshire, or an
explanation detailing why the applicant does not have such an inspection
report.
(c) The applicant shall supplement the
application specified in (a) and (b) above with any certificates, affidavits,
plans, documents or other information sufficient to show full compliance with
all of the requirements of Ph 600.
(d) If the applicant is a corporation, or the
limited retail drug distributor will be operated under a corporate name, a
certificate from the NH secretary of state attesting to the documents creating
the corporate person and any amendment(s) thereof to the certificate of
incorporation, or authorizing it to do business in the state of New Hampshire
under the corporate name shall be included with the application.
(e) If the applicant proposes to hold, store, or dispense
controlled substances as a methadone maintenance/detoxification facility, the
application shall be supplemented with the following information:
(1) A brief description of the
security system;
(2) A list of all persons with
access to the controlled substances;
(3) The applicant shall supplement the
application specified in (a) above with any certificates, affidavits, plans, documents or other information
sufficient to show full compliance with all of the requirements for operation
of a drug abuse treatment facility, as outlined in He-A 304; and
(4) If the application is for a
methadone maintenance/detoxification facility, the applicant shall submit the
current registration number issued by the federal drug enforcement
administration (DEA).
(f) The applicant shall sign, indicate his or her
title, and date the application under the following affirmation:
“I affirm that I am the person authorized to sign this application for
licensure and declare under penalties of unsworn falsification under RSA 641:3
that this application (including any accompanying documents) has been examined
by me and to the best of my knowledge and belief is a true, correct and
complete application, and if the registration herein applied for is granted, I
hereby agree to and do submit to the jurisdiction of the New Hampshire board of
pharmacy and to the laws and rules of this state.”
(g) The board shall issue a
license pursuant to this section if the applicant:
(1) Files a complete application
that meets the requirements of these rules and RSA 318; and
(2) Is of good moral character,
or, if the applicant is an association or corporation, that the managing
officers are of good moral character, as evidenced by the absence, within the
last 5 years, of conviction of any felony, or of a misdemeanor resulting from a
violation of any drug related law of the United States or of any state.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.04 Consultant Pharmacist. All applicants licensed under the provisions
of RSA 318:51-b shall have a written
contract with a pharmacist, licensed in NH, to serve as a consultant on all
matters relating to procurement, storage and dispensing of prescription drugs
as defined in RSA 318:1, XVII.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.05 Changes in Supporting Information. The applicant shall notify the board,
immediately, of any changes of information
from that which was submitted on the original application pursuant to Ph 601.03. Failure to report changes shall result in the
imposition of a $25 administrative fine.
No license shall be issued until all fees and fines are paid in full.
Source. #8572, eff 2-23-06;
ss by #9139-B, eff 4-25-08, EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.06 Renewal Applications.
(a)
The license period shall be from July 1 thru June 30 of every
odd-numbered year.
(b)
Applications for renewal of a license to operate as a limited retail
drug distributor shall consist of prescribed fee as indicated in Ph 601.01(e)
and the following appropriate application form:
(1) For medical gas suppliers, the online License
Renewal Application available
at https://nhlicenses.nh.gov/eGov/Login.aspx;
(2) For clinics under contract with DHHS,the online
License Renewal Application, available at https://nhlicenses.nh.gov/eGov/Login.aspx ; or
(3) For methadone maintenance/detoxification
facilities,the online License Renewal Application, available at https://nhlicenses.nh.gov/eGov/Login.aspx.
(c) Medical
gas supplier and methadone maintenance/detoxification renewal applicants shall
submit the following additional information with their renewal applications:
(1) For
medical gas suppliers:
a. A
copy of the current state license from the applicant’s home state licensing
authority if outside New Hampshire, or an explanation as to why the renewal
applicant does not have such a license; and
b. A
copy of the most recent inspection report from the applicant’s home state
licensing authority if outside New Hampshire, or an explanation as to why the
renewal applicant does not have such an inspection report; and
(2) For
methadone maintenance/detoxification facilities:
a. A
copy of the clinic’s current New Hampshire DHHS certified drug treatment
provider certificate; and
b. A
copy of the clinic’s current DEA registration.
(d) Renewal applications shall include a dated
signature and title under the following affirmations:
(1) For
medical gas suppliers:
“I affirm that I am the person authorized to
sign this application for licensure on behalf of the company/licensee and
affirm that this application (including any accompanying documents) has been
examined by me and to the best of my knowledge and belief is a true, correct
and complete application, and if the registration herein applied for is
granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State.”
(2) For
clinics under contract with DHHS:
“I declare under penalties of unsworn
falsification under RSA 641:3 that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the permit herein applied
for is granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State.”; and
(3) For
methadone maintenance/detoxification facilities:
“I declare under penalties of unsworn
falsification under RSA 641:3 that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the permit herein applied
for is granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State. To the
best of my knowledge, myself nor any of the employees listed on this
application, have been arrested, investigated for, charged with, convicted of,
sentenced, entered a plea of non contendere, or entered into any other legal
agreements for any criminal offense in any state, territory or possession of
the United States or by the federal government.”
(e)
The board shall renew a license pursuant to this section if the
applicant:
(1) Files a complete application that meets the
requirements of these rules and RSA 318; and
(2) Is of good moral character, or, if the
applicant is an association or corporation, that the managing officers are of good moral character, as evidenced by the absence,
within the last 5 years, of conviction of any felony, or of a misdemeanor
resulting from a violation of any drug related law of the United States or of
any state.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 601.07 Temperature. The temperature in any area wherein drugs are
compounded shall, at all times, be in compliance with the standards established
by the United States Pharmacopoeia as defined in Ph 701.02(s).
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.08 Quarantine. Any drug, which is adulterated as defined in
Ph 701.02(a) or misbranded as defined in Ph 701.02(j), shall be removed from
the routine stock and held in a specifically designated secure area of the
facility pending proper and safe disposition.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.09 Space.
Drugs shall be housed in a well-lighted and ventilated room or
department with clean and sanitary surroundings.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.10 Security.
(a) That portion of the facility where drugs are
stored, compounded or dispensed, shall be lockable so as to prevent entry into
that area by any person or persons without the knowledge of the authorized
individuals on duty, or when the facility is not open.
(b) If the facility contains controlled
substances, it shall be equipped with an alarm system as referenced in Ph
1002.03.
(c) Methadone maintenance/detoxification facilities
shall ensure that all access from outside their premises is secure. This shall include, but not be limited to,
the installation of adequate lighting to illuminate the outside perimeter of
the premises.
(d) All controlled substances shall be stored
pursuant to the security provisions outlined in 21 CFR 1301.72(a).
(e) For those facilities which are open to the
public 24 or more hours per week, the consultant pharmacist shall visit, at
least monthly, all areas of the facility where drugs are stored to ensure that
they are properly labeled, have not reached their expiration date and show no
signs of deterioration. Any drugs not
conforming to these standards shall be removed from stock. For facilities which are open to the public
less than 24 hours per week, such visits shall be conducted on a quarterly
basis.
(f) The consultant pharmacist shall create a
written record of each monthly and/or quarterly inspection, specified in (e),
which shall be maintained on site and available to the board upon request.
(g) The pharmacist shall ensure that the areas
specified in (e) above are in compliance with federal and state drug laws
relative to security, drug distribution and product tampering.
(h) The consultant pharmacist shall develop a
distribution system that prevents the illegal diversion of drugs. Where applicable, the inventory of all
schedule II controlled substances and other controlled drugs stored in any area
of the facility, shall be checked by 2 persons at least every 24 hours and accountability
records shall be completed by the nursing or medical staff and maintained
on-site for inspection by the consultant pharmacist.
(i) Notwithstanding (h) above, in situations at
the methadone maintenance/detoxification facilities that result in only one
staff member being present, the
inventory shall be counted, signed, dated and shall be “cosigned” immediately
upon the presence of a second staff member. However, at no time shall there
lapse more than 72 hours before this inventory verification by a second
party.
Source. #8572, eff 2-23-06;
amd by #9139-B, eff 4-25-08; paragraphs
(a)-(g) EXPIRED: 2-23-14; paragraph (h)
EXPIRED:
4-25-16
New. #12335, eff 7-22-17
Ph 601.11 Dispensing Practices.
(a) Drugs shall be dispensed only by or in the
presence of and under the supervision of a pharmacist, physician, advanced
registered nurse practitioner, physician assistant, or registered nurse as
identified in RSA 318:42,VII (a), in compliance with state and federal
pharmacy-related laws and rules.
(b)
In the case of methadone
maintenance/detoxification facilities and according to the provisions of RSA
318:42 the dispensing of narcotics is extended to employees of the clinic, authorized
in writing according to the provisions of 21 CFR 1301.74(i) of the federal law.
Source. #8572, eff 2-23-06;
amd by #9139-B, eff 4-25-08; paragraphs (c) and (d) EXPIRED: 2-23-14 paragraphs (a)
& (b) EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.12 Deliveries.
(a) All drug order deliveries containing prescription
drugs shall be delivered only when a licensed practitioner is on the premises
in order to secure such drug orders.
(b) In the case of methadone
maintenance/detoxification facilities, drug deliveries may be accepted only by
the licensed practitioner or other individuals identified according to the
requirements of 21 CFR 1301.74(h).
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.13 Access to Drug Supply.
(a) Only the pharmacist, physician, advanced
registered nurse practitioner, physician assistant or registered nurse, as
identified in RSA 318:42 shall have access to the drug supply.
(b)
In the case of methadone maintenance/detoxification facilities, access
to the drug storage area may also be extended to licensed
practical nurses provided such authorization is granted, in writing, according
to the provisions of 21 CFR 1301.72(d) of the federal law.
(c)
Methadone maintenance/detoxification facilities shall supply the board
with a list of all individuals that have been granted access to the drug supply, and, should this list change,
the board shall be notified, in writing, within 72 hours of such changes.
Source. #8572, eff 2-23-06;
ss by #9139-B, eff 4-25-08 EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.14 Dispensing Records.
(a) A readily retrievable record, completed by the
nursing or medical staff, shall be made of all administration or dispensing of
prescription drugs from the facility.
(b) The record, as specified in (a) above, shall
be separate from the patient’s medical record and include:
(1) Name and address of the
patient;
(2) Date of administration or
dispensing;
(3) Name, strength and quantity of
drug(s) administered or dispensed;
(4) Identity of the prescriber;
and
(5) Signature of the person
administering or dispensing.
(c) Methadone maintenance/detoxification
facilities shall maintain a dispensing log, completed by the nursing or medical
staff, containing the following information:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date administered;
(5) Patient identification number;
(6) Amount consumed;
(7) Amount and dosage form taken
home; and
(8) Dispenser’s signature.
(d) Records of administrations and dispensing as
specified in (b) and (c) above shall be maintained for a period of 4 years. Such records shall be open to inspection by
the pharmacy board and its agents during regular business hours.
Source. #8572, eff 2-23-06;
amd by #9139-B, eff 4-25-08; paragraphs (a)-(c)(4), (c)(6)-(7), & (d)
EXPIRED: 2-23-14 paragraph (c) intro. & (c)(5) EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.15 Prescription Labels.
(a) Whenever an authorized practitioner dispenses
a controlled drug, as defined in RSA 318-B:1-a and b, or a non-controlled
prescription drug, as defined in RSA 318:1, XVII, he/she shall affix to the
container in which such drug is dispensed, a label showing at least:
(1) Name and address of the
facility;
(2) Name of the patient;
(3) Date dispensed;
(4) Name, strength and quantity of
drug dispensed;
(5) Directions for use;
(6) Name of the prescribing
practitioner;
(7) Name or initials of the
dispensing practitioner; and
(8) All pertinent auxiliary
labels.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.16 Labeling Exemption. The labeling requirements, as specified in Ph
601.15, shall be exempted when medication is being administered for immediate
consumption, such as in a methadone maintenance/detoxification facility.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
Ph 601.17 Violations. Any person who distributes legend drugs
according to RSA 318:51-b and the provisions of Ph 600, shall be subject to
disciplinary action as provided in RSA 318:29.
Source. #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #12335, eff 7-22-17
PART Ph 602 MEDICAL GASES
Ph 602.01 Biennial Registration Required. Pursuant to Ph 601.06, every person, or corporate
entity that is not a licensed pharmacy, engaged in supplying medical gases to the consuming public, or to a patient
or a patient's agent, in the state of New Hampshire, shall renew biennially
with the board as a limited retail drug distributor no later than June 15th
of every odd-numbered year.
Source.
#12335, eff 7-22-17; ss by #13117, eff 10-15-20
Ph 602.02 Medical Gas Supplier Requirements.
(a) The limited retail drug distributor license shall
be posted in a conspicuous place in the wholesaler's place of business for
which it is issued.
(b)
A medical gas supplier shall not:
(1) Supply prescription medications, except medical
gases, without appropriate licensure as a limited retail drug distributor;
(2) Manufacture or distribute medical gases
without appropriate licensure as a limited retail drug distributor; or
(3) Instruct patients regarding clinical use of
equipment, or provide any monitoring, assessment, or other evaluation of
therapeutic effects without appropriate licensure as a respiratory care
practitioner.
(c) A medical gas supplier shall supply medical gas
only pursuant to prescription order by an authorized prescriber.
(d) A medical gas supplier shall label each
medical gas container with the name, address, and telephone number of the
supplier.
(e) A medical gas supplier shall establish and
implement written procedures for maintaining records pertaining to the
acquisition and supply of, and complaints related to, medical gases.
(f) Records shall be retained for at least 3
years after supply to a patient or one year after the expiration date of the medical
gas, whichever is longer.
(g) Medical gases and equipment shall be secure
from unauthorized entry and have a system to detect or deter entry after hours
and provide protection against theft.
(h) The facility shall be maintained in a clean
and orderly condition, and only service animals shall be allowed.
(i) A policy and procedure shall be in place for:
(1) Recalls;
(2) Emergencies;
(3) Shipping and receiving;
(4) Returned goods; and
(5) Outdates.
(j) Records shall be readily available for review
by the board or its inspector during regular business hours.
Source.
#12335, eff 7-22-17
CHAPTER Ph
700 STANDARDS OF PRACTICE
PART Ph 701 REFERENCES AND DEFINITIONS
Ph 701.01 Applicability. The provisions of this chapter shall apply
to, and impose duties upon, all pharmacists, pharmacies, manufacturers, wholesalers and distributors holding
licenses issued by the board.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 701.02 Definitions. Except where the context makes another
meaning manifest, the following words mean:
(a)
"Adulterated drug" means any drug:
(1) That is contaminated,
decomposed, deteriorated, sub‑potent, super‑potent, or otherwise
unsafe for administration to man or other animals;
(2) Which has been manufactured,
composed, prepared, stored, or dispensed in such a manner which may cause it to
be contaminated, decomposed, deteriorated, sub‑potent, super‑potent,
or otherwise unsafe for administration to man or other animals; and
(3) Which can be defined as an adulterated drug under the provisions of
RSA 146:4 or federal law.
(b)
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, or other similar or related article, including any
component part or accessory, which is required under federal law to bear the
label, "Caution: Federal or State
law requires dispensing by or on the order of a physician" or “Rx only”.
(c)
“Distributor” means a person or persons who supplies or facilitates the
supply of prescription drugs or devices to someone other than the patient,
including, but not limited to, manufacturers, repackagers, brokers and
wholesale drug distributors.
(d)
"Drug outlet" means all pharmacies, limited retail drug
distributors, durable medical equipment providers, dispensing practitioners,
hospitals, drug abuse treatment centers, retail stores, penal institutions,
infirmaries, clinics and federal or state facilities that are engaged in
delivery or distribution of drugs.
(e)
"Drug room" or "medication room" means that room or
area in an institution used to store prescription drugs.
(f)
"Electronic prescription" means transmission of information in
electronic form, modem to modem, by way of electronic equipment.
(g)
“Facsimile prescription” means the transmission of the exact visual
image of a document by way of electronic equipment.
(h)
"Institution" means a health care facility which provides
inpatient care and includes:
(1) Hospitals;
(2) Nursing homes;
(3) Extended care facilities;
(4) Residential care facilities;
(5) Infirmaries;
(6) Correctional facilities; and
(7) Clinics.
(i)
"Institutional pharmacy" means an area in an institution where
drugs are stored, manufactured, compounded, dispensed, or issued to other areas
or departments of the institution.
(j)
"Misbranded drug" means a drug:
(1) Whose label misrepresents the contents or is
misleading;
(2) If dispensed by prescription, a drug whose
label does not comply with the provisions of RSA 318 or RSA 318‑B; and
(3) Which can be defined as a misbranded drug
under the provisions of RSA 146 or federal law.
(k)
"NH Pharmacy Law Book" means a publication of the board which
contains RSA 318, RSA 318‑B and Ph 100 through Ph 1700 and any future
chapters.
(l) "Prescriber" means a
practitioner, duly authorized by statute, who issues a drug order or
prescription.
(m)
"Principal" means an officer, director, or primary stockholder
of a business entity or corporation.
(n)
"Professional corporation" as used in these rules means a
corporation organized under RSA 294-A for the purpose of providing professional
services in the field of medicine, dentistry, veterinary, podiatry, or any
other profession in which individual practitioners can lawfully possess,
dispense, or distribute prescription drugs.
(o)
“Signature” means:
(1) The handwritten name of an
individual affixed by the hand of that individual to a document;
(2) An electronic sound, symbol,
or process attached to or logically associated with a record and executed or
adopted by a person with the intent to sign a document or record; or
(3) An electronic signature.
(p)
"Traditional physician‑pharmacist‑patient
relationship" means a situation whereby the pharmacist knows either the
physician, the patient, or both, and/or can readily and easily check on factors
concerning the prescription.
(q)
"Unit-dose" means a single-unit container that is designed to
hold a quantity of drug product intended for administration as a single dose
and labeled with the identity, quantity and/or strength, name of the
manufacturer, lot number and expiration date of the drug product.
(r)
"Unprofessional conduct" means conduct and practices which are
hostile to the protection of public health, safety and welfare and includes:
(1) Knowingly engaging in any activity which
violates state and federal statutes, regulations and rules governing the
practice of pharmacy;
(2) Knowingly dispensing an outdated product;
(3) Knowingly charging for more dosage units than
are actually dispensed;
(4) Knowingly altering prescriptions or other
records which the law requires the pharmacy or pharmacist to maintain;
(5) Knowingly dispensing medication without
proper authorization or prescription;
(6) Defrauding any persons or government agency
receiving pharmacy services; or
(7) Placing a signature on any affidavit
pertaining to any phase of the practice of pharmacy which the pharmacist knows
to contain false information.
(s)
"USP" means the United States Pharmacopeia, published by and
issued under the authority of the Pharmacopeial Convention, which provides
recognized standards and specifications for all drug entities in the U.S.
(t)
"Wholesale drug distribution" means distribution of prescription
drugs other than to the patient, including, but not limited to distribution by
manufacturers, repackers, own label distributors, jobbers, and wholesale drug
distributors.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
amd by #7535, eff 8-1-01; paragraph (a) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; amd by #8572, eff 2-23-06; paragraphs (b), (d)-(m), and (p)-(s)
EXPIRED: 2-1-07; paragraph (o) EXPIRED: 8-1-09; paragraph (a) EXPIRED: 3-26-13;
paragraphs (c) and (n) EXPIRED: 2-23-14
New. #10903, eff 8-5-15
Ph 701.03 References. Persons subject to these rules shall comply
with the following regulations and statutes as cited:
(a)
RSA 146, Purity and Branding of Foods and Drugs;
(b)
RSA 318, Pharmacists and Pharmacies;
(c)
RSA 318-B, the
(d)
21 USC Sections 300 through 369, the Federal Food, Drug, and Cosmetic
Act;
(e)
21 CFR 1300 to end; and
(f)
The
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
PART Ph 702 PHARMACY FACILITIES AND EQUIPMENT
Ph 702.01 Area, Space and Fixtures.
(a)
Pharmaceuticals, library and equipment shall be housed in a well-lit and
ventilated room or department with clean and sanitary surroundings devoted
primarily to the preparation and dispensing of prescriptions. This portion of a pharmacy shall have an area
of not less than 200 square feet. No
area shall be included in the calculation of the minimum area required by this
section unless that area is used exclusively for the storage, manufacture,
preparation and dispensing of drugs.
(b)
The space primarily devoted to the preparation of prescriptions shall be
equipped with:
(1) Necessary counters and storage cabinets;
(2) A sink with hot and cold running water with
plumbing that meets all applicable state and local building codes ; and
(3) Temperature controlled storage equipment used exclusively for drugs.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paragraphs (a)-(b)(2) and (c) EXPIRED: 3-26-13; paragraph (b)(3)
EXPIRED: 2-23-14
New. #10903, eff 8-5-15
Ph 702.02 Temperature. The temperature in any area wherein drugs are
stored, manufactured, prepared or dispensed, shall be monitored and at all
times be in compliance with the standards established by the manufacturer.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 702.03 Quarantine. Any drug which is expired, adulterated or
misbranded shall be removed from routine stock and held in a specifically
designated area of the pharmacy pending proper and safe disposition.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 702.04 Security.
(a)
That portion of a pharmacy wherein drugs are stored, manufactured,
prepared or dispensed, shall, when the pharmacy is open, be so designed and
constructed as to prevent entry into that area by any person or persons without
the knowledge of the pharmacist then on duty, or when the pharmacy is not open
to the public, by the activation of an alarm.
(b)
The pharmacy shall be equipped with an alarm system which, when
activated, shall emit a signal which is:
(1) Audible to the average person situated
outside the building in which the pharmacy is located, at least 100 feet from
any point of that building, or the public highway closest to that building,
whichever is greater; or
(2) Observable by a law enforcement or security
officer situated in a station of the law enforcement organization having
jurisdiction over the area in which the pharmacy is located, an office of a security organization serving
the area in which the pharmacy is located or an alarm monitoring company.
(c)
In order to be adequately designed and constructed, within the meaning
of this section, a pharmacy shall be equipped with a door or doors capable of
being locked.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 702.05 Limitations on Access.
(a) Except as provided in Ph
704.01(b), no pharmacy
shall be open unless a pharmacist is on duty.
At all times during which a pharmacist is not on duty in the pharmacy,
all entry to the licensed pharmacy area shall be barred by locked doors.
(b)
The keys to the locked doors of a pharmacy shall be possessed only by:
(1) The pharmacist-in-charge;
(2) Pharmacists in the employ of the pharmacy;
(3) A non-pharmacist owner or owners of the
pharmacy; or
(4) Store management and security personnel when
secured in a locked safe in the building and kept separate from the alarm code
needed to access the secured area.
(c)
A non-pharmacist owner or owners may be on the premises of a pharmacy
which he or she owns in the absence of a pharmacist employed by that pharmacy,
provided that the pharmacy is not open and no drugs are prepared, dispensed or
sold.
(a) Except as provided in Ph
704.01(b), no pharmacy
shall be open unless a pharmacist is on duty in the pharmacy. At all times during which a pharmacist is not
on duty in the pharmacy, all entry to the pharmacy shall be barred by locked
doors.
(b)
The keys to the locked doors of a pharmacy shall be possessed only by:
(1) The pharmacist-in-charge;
(2) Pharmacists in the employ of the pharmacy;
(3) A non-pharmacist owner or owners of the
pharmacy;
(4) Qualified security personnel as shall be designated
by the pharmacist-in-charge and a list of such personnel shall be filed with
the board by the pharmacist-in-charge; or
(5) If an institutional pharmacy, administrators of
the institution and those nurses designated to enter the pharmacy to obtain
medications in emergency situations.
(c)
A non-pharmacist owner or owners may be on the premises of a pharmacy
which he or she owns in the absence of a pharmacist employed by that pharmacy,
provided that the pharmacy is not open and no drugs are compounded, dispensed
or sold.
(d)
The pharmacy permit shall be issued to the pharmacy in the name of the
pharmacist-in-charge, who shall have sole control and responsibility for the operation of the
pharmacy in
accordance with all laws and rules pertaining to the practice of pharmacy in
this state and always in the best interest of public health and safety.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a)-(c) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; amd by #8572, eff 2-23-06; para. (d) EXPIRED:
2-1-07; ss by #10456, eff 11-1-13; ss by #10903, eff 8-5-15
Ph
702.06 Minimum Drug Standards. Registrants shall comply with the minimum
drug standards set forth in the latest edition of the United States Pharmacopeia
(USP).
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 702.07 Minimum Standard of Technical Equipment
and Stock.
(a)
Permit holders shall provide that every pharmacy shall have contained
therein, at all times, the following:
(1) Prescription labels showing the name,
address, telephone number and DEA number of the pharmacy;
(2) All equipment, supplies and drugs that are
relevant to the practice and meet all state and federal standards;
(3) An assortment of auxiliary labels or the software
to produce them;
(4) A current reference library, or the ability
to access references on line, as determined by the pharmacist-in-charge to meet
the needs of the practice, and specialties, of that pharmacy and the patients
it serves; and
(5) A current copy, with supplements, or the
ability to access on line within the licensed area the New Hampshire Pharmacy
Law Book.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10102, eff 3-30-12; ss by #10903, eff 8-5-15
PART Ph 703 RECORDS AND REPORTS
Ph 703.01 Recordkeeping Requirements.
(a)
The requirements of Ph 703 shall be in addition to all record keeping
and reporting requirements contained in all federal and state rules and
regulations.
(b)
Hard copies of prescription records and reports shall not be required to be maintained if they can be
reproduced on demand with the exception of Schedule II – V controlled substance
prescriptions not presented in electronic format.
(c)
Hardcopy prescriptions for Schedule II –V controlled substances shall be
kept on file for 4 years.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 703.02 Prepackaging of Drugs.
(a)
Drugs shall be prepackaged in quantities suitable for internal
distribution only by a pharmacist or by supportive personnel under the direct
supervision of a pharmacist.
(b)
The label of a prepackaged unit shall indicate the:
(1) Brand name and strength of the drug, or if no
brand name, the generic name, strength, and name of the manufacturer or
distributor;
(2) Assigned in‑house, quality control lot
number;
(3) Expiration date; and
(4) Quantity of the drug, if the quantity is
greater than one.
(c)
The pharmacist who prepackages or supervises prepackaging shall maintain
a written or electronic
record that contains at least the following information:
(1) Name of the drug, strength, and dosage form;
(2) Assigned in-house, quality control lot
number;
(3) Manufacturer or distributor;
(4) Manufacturer's lot number;
(5) Expiration date;
(6) Quantity per prepackaged unit;
(7) Number of prepackaged units;
(8) Date packaged;
(9) Identifier of the prepacker; and
(10) Signature of the responsible pharmacist.
(d)
Stock packages, repackaged units, and control records shall be
quarantined together until checked/released by the pharmacist.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15 (from Ph 703.03)
Ph 703.03 Controlled Drug Losses.
(a) The pharmacist-in-charge or pharmacist on
duty shall report to the board in writing, any theft or significant loss of
controlled substances within one business day.
The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form (revised 5/2015) or DEA 106 Form
and mail or fax to the board as soon as the investigation into the loss is
complete or within 30 days of the discovery of the loss.
(b) All instances of diversion
shall be reported.
(c)
A pharmacy shall keep a perpetual inventory for all Schedule II drugs
and actual counts shall be verified monthly. The inventory reports shall be
maintained for a minimum of 2 years.
(d)
A pharmacy shall consider a controlled drug loss to be significant when:
(1) The percentage of dosage
units of a specific drug exceeds 2% of monthly dispensing volume; or
(2) Fifteen or more dosage units
are not accounted for.
(e)
The written report referenced in (a) shall contain at least the
following:
(1) Date of discovery;
(2) The identity of the person
making the discovery;
(3) The name and location of
the pharmacy from which the drug is missing;
(4) Name, strength, dosage
form, NDC and quantity of the missing drug(s); and
(5) The cause of the controlled
drug loss as determined by the investigation.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15 (from Ph 703.04)
Ph 703.04 Automated Data Processing Systems. All pharmacies shall have an automated data
processing system to be used for the storage of original, faxed or written
prescriptions and the retrieval of refill information for all prescription
orders including, but not limited to, controlled substances in schedules II,
III, IV, and V, as defined in 21 CFR 1308.11-1308.15 subject to the following
conditions:
(a)
The system shall provide security against improper manipulation or
alteration of stored records. Individual
access codes shall be unique to each licensed location and shall not be
available to any other location;
(b)
A pharmacy shall make arrangements with the supplier of data processing
services or materials to assure that the pharmacy continues to have access to
the complete prescription and dispensing records if the relationship with such
supplier terminates for any reason. A
pharmacy shall assure continuity in the maintenance of records for the
protection of public health;
(c)
Any computerized system shall provide on-line retrieval, via electronic
display or hard-copy printout, of all prescription records processed at
that licensed location;
(d)
The information required by (c) above shall include:
(1) The original prescription number;
(2) The date of issuance of the original
prescription order by the practitioner;
(3) The full name and address of the patient;
(4) The name, address, and DEA registration
number of the practitioner, when applicable;
(5) The name, strength, dosage form, quantity prescribed,
and quantity dispensed if different from the quantity prescribed, and the total
number of refills authorized by the prescribing practitioner, if any; and
(6) The date each
fill is dispensed.
(e)
Any computerized system shall also provide on-line retrieval, via
electronic display or hard-copy printout, of the current refill history of all
prescription orders including controlled substances in schedules III, IV, and
V;
(f)
This refill history shall include:
(1) The name of the drug;
(2) The date of refill;
(3) The quantity dispensed;
(4) The identification code, or name or initials
of the dispensing pharmacist for each refill; and
(5) The total number of refills dispensed to date
for that prescription order;
(g)
Documentation of the fact that the refill information entered into the
computer each time a pharmacist refills an original prescription order,
including refill orders for a schedule III, IV, or V controlled substances is
correct shall be provided by:
(1) A hard-copy printout of each day's controlled
substance prescription order refill data which shall be verified, dated, and
signed by each pharmacist who refilled such prescription orders; or
(2) In lieu of such a printout, the pharmacy
shall maintain a bound log book, or separate file, in which each individual
pharmacist involved in such dispensing shall sign a statement each day,
attesting to the fact that the refill information entered into the computer
that day has been reviewed by him and is correct as shown;
(h)
The hard-copy printout or log book referenced in (g) above shall be kept
at the pharmacy, in a separate file, for a period of 4 years from the
dispensing date;
(i)
The computerized system shall have the capability of producing a
printout of all refill data and shall include:
(1) A refill-by-refill audit trail for any specified
strength and dosage form of any controlled substance;
(2) Name of the prescribing practitioner;
(3) Name and address of the patient;
(4) Quantity dispensed on each refill;
(5) Date of the dispensing for each refill;
(6) Name or identification code of the dispensing
pharmacist; and
(7) The number of the original prescription
order;
(j)
In any computerized system employed by a user pharmacy, the central
recordkeeping location shall be capable of sending the printout to the pharmacy
within 48 hours;
(k)
Each pharmacy using an automated data processing system shall maintain
on file a hard copy of all controlled substance prescriptions in schedules II,
III, IV and V, excluding electronic, preserving all information contained on
the original written or oral prescription.
Any computer generated material shall be affixed to the rear of the
prescription, leaving the face of the prescription intact; and
(l)
Computer-produced prescription container labels shall comply with RSA
318:47-a, RSA 318:47-b and RSA 318-B:13, II.
Source.
#2118, eff 8-12-82: ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15 (from Ph 703.05)
Ph 703.05 Federal DEA #222 Order Forms. All used DEA #222 order forms or any
successor forms shall be maintained on the premises to which the forms and the
corresponding DEA permit number were issued. In the case of on-line ordering of
CII drugs, all records of such shall be maintained on said premises and be
readily retrievable. Such records shall
meet the requirements of federal laws and regulations and shall be maintained
for a period of not less than 2 years.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10066, eff 12-28-11; ss by #10903, eff
8-5-15 (from Ph 703.06)
Ph 703.06 Inspection Report. The current compliance inspection report of
the licensed location, conducted by the board, shall be kept on file in the
prescription department.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15 (from Ph 703.07)
PART Ph 704 DISPENSING OF DRUGS AND DEVICES
Ph
704.01 Presence of Pharmacists.
(a) No pharmacist shall work more than 8 hours
without a rest break of 30 minutes.
Breaks shall be scheduled as close as possible to the same time each day
so that patients may become familiar with the approximate break times.
(b) Whenever the prescription department is
staffed by a single pharmacist, the pharmacist may take a rest break for a
period of 30 minutes without closing the pharmacy and removing support
personnel from the pharmacy, provided that the pharmacist reasonably believes
that the security of the prescription drugs will be maintained in the
pharmacist’s absence.
(c) Pharmacy technicians, NH certified pharmacy
technicians and pharmacy interns may remain in the pharmacy if the pharmacist
on duty reasonably believes that the security of the prescription drugs will be
maintained in his or her absence and in accordance with the following:
(1)
Rest breaks shall be scheduled as close as possible to the same time
each day in order for the patients to become familiar with the approximate
times of breaks;
(2)
The pharmacist shall remain on the premises, within the building, during
the rest break and be available for emergencies. Emergencies shall be defined by the
pharmacist;
(3)
Whenever the pharmacist temporarily leaves the prescription department
for a rest break, a sign indicating that there is no pharmacist on duty shall
be conspicuously displayed in full view of patients approaching the
prescription department service area. The signage shall also indicate the time
when the pharmacist is to return;
(4)
Only pharmacy technicians or pharmacy interns authorized by the pharmacist
on duty may remain in the pharmacy while the pharmacist is on break;
(5) During such times that the pharmacist is
temporarily absent from the pharmacy, only pharmacy technicians or pharmacy
interns duly authorized by the pharmacist on duty may continue to perform
non-discretionary duties as delineated by the pharmacist. However, all duties performed by the
technicians or interns shall be reviewed by the pharmacist upon his or her
return from break;
(6) When a pharmacist is not in the
pharmacy, there shall be no dispensing or sale of new prescriptions that the
pharmacist has checked and are waiting to be picked up nor shall counseling be
provided by the pharmacy technician or pharmacy intern;
(7)
New, written prescriptions, presented in person by the patient or his
agent, may be accepted by the pharmacy technician or pharmacy intern and the
processing of that prescription, up to the final check, may occur during the
absence of the pharmacist. However, no new prescriptions may be dispensed or
sold until the final check is completed by the pharmacist on his or her return;
(8)
New prescriptions conveyed by telephone shall be accepted by a NH
certified pharmacy technician or pharmacy intern or when authorized by the
pharmacist or the caller shall be instructed to call back or a telephone number
obtained for the pharmacist to call upon his or her return;
(9)
During the pharmacist’s absence, prescription refills which have been
previously prepared and checked by a pharmacist may be picked up by the patient
or his agent. If the patient has no
questions, the sale may proceed as normal with the patient signing a statement
indicating the refusal of counseling by the pharmacist. If the patient desires counseling, he or she
shall be asked to wait for the pharmacist to return from break or,
alternatively, asked to leave a telephone number for the pharmacist to call
later that day; and
(10)
Telephone refill orders as well as refill requests presented, in person,
by the patient or his agent, may be accepted by the pharmacy technician or
intern and such refill orders may be processed by the technician or intern up
to the final check. However, no such
refill orders shall be dispensed or sold until the final check is completed by
the pharmacist on his or her return from break.
(d) A pharmacist who takes a rest break in
compliance with this section shall continue to be responsible for the operation and security of the pharmacy
department. Therefore, if in the professional judgment of the pharmacist, for
reasons of security or otherwise, the pharmacist determines that the pharmacy
should close during his or her absence, then the pharmacist shall close the
pharmacy. All pharmacy technicians, NH
certified pharmacy technicians,
and pharmacy interns shall leave the pharmacy during his or her
absence. A sign informing the public of
the pharmacist’s return shall be conspicuously posted.
(e) Pharmacists shall follow company protocols in
leaving the pharmacy department unattended for any reason, such as but not limited to
counselling patients, giving immunizations, or rest room breaks.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99;
ss by #8572, eff 2-23-06; ss by#10459, eff 11-1-13; ss by #10903, eff 8-5-15;
ss by #11189, eff 9-23-16
Ph 704.02 Pre-signed Prescription Blanks. No person shall possess, and no pharmacy
shall have within it, any document signed by a prescriber which, if completed,
would be usable as a prescription.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.03 Transmission of
Prescription Drug Order by Prescriber.
(a) A prescription drug order may be transmitted
to a pharmacy by an authorized prescriber or his designated agent in
writing, orally, by facsimile or electronically.
(b) A facsimile or electronically transmitted prescription drug or device
order shall:
(1) Be sent to the pharmacy of the
patient's choice;
(2) For a non-controlled substance
prescription drug or device order, include:
a. The name of the patient;
b. The name, strength, and quantity of the drug
prescribed;
c. Any directions specified by the prescribing
practitioner;
d. The name and address of the prescribing
practitioner which shall be printed or typewritten;
e. The prescribing practitioner’s phone number
for verbal confirmation; and
f. The date the prescription was ordered;
(3) For a schedule III through V controlled
substance prescription drug order, as defined in RSA 318-B:1-b and transmitted
by facsimile or as an electronic prescription, shall include:
a. The name and address of the patient;
b. The name, strength, and quantity of the drug
prescribed;
c. Any directions specified by the prescribing
practitioner;
d. The full name of the prescribing practitioner
which shall be printed, rubber stamped, or typewritten above or below his or
her handwritten signature;
e. The address of the prescribing practitioner;
f. The federal drug enforcement administration
(DEA) number assigned to the prescribing practitioner; and
g. The date the prescription was ordered;
(4) A
facsimile prescription for a schedule II controlled substance shall not be
accepted as an original written prescription except in circumstances when:
a. A prescription prepared in accordance with RSA
318-B:9, III and IV, and issued for a schedule II substance, as defined in RSA
318-B:1-b, to be compounded for the direct administration to a patient in a
private residence, long-term care facility, or hospice setting, by parenteral,
intravenous, intramuscular, subcutaneous or intraspinal infusion may be
electronically transmitted, by the practitioner or the practitioner’s
designated agent to the dispensing pharmacy.
The printed copy of the transmission shall serve as the original written
prescription and shall be maintained in accordance with the provisions of RSA
318-B:9, I;
b. A prescription prepared in accordance with
RSA 318-B:9, III and IV, and issued for a schedule II substance, as defined in
RSA 318-B:1-b, for a resident of a long-term care facility may be
electronically transmitted by the practitioner or the practitioner’s designated
agent to the dispensing pharmacy. The
printed copy of the transmission shall serve as the original written
prescription and shall be maintained in accordance with the provisions of RSA
318-B:9, I; and
c. A prescription prepared in accordance with
RSA 318-B:9, III and IV, and issued for a schedule II substance, as defined in
RSA 318-B:1-b, for a patient enrolled in a hospice care program, may be
electronically transmitted by the practitioner or the practitioner’s designated
agent to the dispensing pharmacy. The
practitioner or the practitioner’s designated agent shall note on the
prescription that the patient is a hospice patient. The printed copy of the transmission shall
serve as the original written prescription and shall be maintained in
accordance with the provisions of RSA 318-B:9, I;
(5) The pharmacist shall exercise professional
judgment regarding the accuracy and authenticity of the electronically
transmitted prescription drug order which shall be consistent with existing
federal or state laws and rules;
(6) For controlled substances in
schedules II, III, IV or V, as defined in RSA 318-B:1-b, a pharmacy may receive an electronically transmitted
drug order from the prescriber for filling provided that it is transmitted in
accordance with federal law with an electronic signature meeting security requirements required by the
Drug Enforcement Agency (DEA) for electronic prescriptions; and
(7) The devices used for the
receipt of facsimile or electronically transmitted prescription drug orders
shall be located in the prescription department of the pharmacy in order to protect
patient confidentiality and to assure security.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06;
ss by #10224, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 704.04 Transfer of Prescriptions. Original prescription drug order information
for drugs may be transferred between pharmacies for the purpose of refill
dispensing subject to the following:
(a) The transfer of controlled drug prescriptions
shall be communicated between 2 licensed pharmacists;
(b) The transfer of non-controlled
prescriptions shall be communicated between 2 licensed pharmacists, NH
certified pharmacy technicians or pharmacy interns; and
(c)
The transferring pharmacist, NH certified pharmacy technician or
pharmacy intern shall notate in the computer record the following:
(1) That a copy has been issued, the date of
transfer, and the name of the pharmacist transferring the prescription; and
(2) The name,
address, phone number and DEA number of the pharmacy to which the prescription
was transferred and the name of the pharmacist receiving the prescription
information.
(d)
When a prescription is transferred, no further refills shall be issued
by the transferring pharmacy.
(e)
The pharmacist receiving the transferred prescription information shall:
(1) Include the word "transfer" on the
face of the transferred prescription; and
(2) Provide all information required to be on the
prescription including the:
a. Patient's name and address;
b. Doctor's name and address;
c. Date of issuance of the original prescription
and date of transfer;
d. Number of valid refills remaining and date of
last refill;
e. Pharmacy name, address,
and original prescription number from which the prescription information was
transferred;
f. Full name of the transferor pharmacist, NH
certified pharmacy technician or pharmacy intern; and
g. DEA registration number of the transferor
pharmacy for controlled substances.
(f)
The pharmacist shall maintain both the original and transferred
prescription as if they were original prescriptions.
(g)
A transferred prescription may be refilled, without limitation, up to
the number of remaining refills, as originally authorized, or up to one year
from the date of original issue, whichever shall occur first.
(h)
The transfer of original prescription drug order information for
controlled substances listed in Schedule III, IV or V shall conform to the
requirements of 21 CFR 1306.26 and shall be permissible between pharmacies on a
one-time basis and shall not be further transferred.
(i)
For non-controlled drugs, 2 or more pharmacies may establish and use a
common electronic file to maintain required dispensing information. Pharmacies using such a common electronic
file shall not be required to physically transfer prescriptions or information
for dispensing purposes between or among pharmacies participating in the same
common prescription file, except that any such common file shall contain
complete and adequate records of such prescription and the date and location of
each refill dispensed and provisions shall be made to assure that the number of
authorized refills shall not be exceeded.
(j) New or on-hold prescription
orders for prescription orders other than control substances may be transferred
to another pharmacy provided that a copy of the original prescription or
electronic transmission is provided to the pharmacy accepting the transfer.
(k) New or on-hold prescription
orders for controlled substances shall not be transferred to another pharmacy.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; ss by #10458, eff 11-1-13; ss by #10903, eff 8-5-15
Ph 704.05 Schedule V Controlled Substances. All cough syrups containing codeine shall not
be dispensed without a prescription.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.06 Drug Product Selection.
(a)
Unless instructed otherwise by the person receiving the drug pursuant to
the prescription, a pharmacist filling a prescription for a drug product
prescribed by its trade or brand name may select a therapeutically equivalent
drug product with the same established name, active ingredient, strength,
quantity and dosage form as the drug product identified in the prescription.
(b)
Therapeutically equivalent drugs shall include only those drug products
listed in "Approved Prescription Drug Products with Therapeutic
Equivalence Evaluations" Published by the United States Department of
Health and Human Services, according to RSA 146-B:2, I, or any written
notification or confirmation from the federal Food and Drug Administration
(FDA) that a drug product is a therapeutically equivalent drug product.
(c)
The pharmacist shall not
select an equivalent drug product:
(1) If the prescriber handwrites “medically
necessary” on the written prescription;
(2) If when ordering a prescription orally, the
prescriber specifies that the prescribed drug is medically necessary; or
(3) If the prescription is electronically
transmitted, the prescriber includes a statement on the face of the
prescription indicating medically necessary.
(d)
The pharmacist shall not select an equivalent drug product unless its
price to the purchaser is less than the price of the prescribed drug product.
(e)
Unless the prescriber instructs otherwise, the label for every drug
product dispensed shall include the product's trade or brand name, if any, or
its established generic name and the name of the manufacturer, packer or
distributor, using abbreviations such as the National Drug Code (NDC) number if
necessary. In the interest of public
health and safety, the pharmacist may, when dispensing a generic drug, include
the brand name on the prescription label following the generic name. The
brand name, however, shall be preceded or followed with the word
"sub", indicating substituted for, or "I.C.", indicating
interchanged for or “generic for”.
(f)
The pharmacy file copy or computer record of every dispensing of a
prescription shall include the trade or brand name, the name of the
manufacturer, and the packer or distributor of the drug product dispensed.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paragraphs (a), (d), (e), & (g) EXPIRED: 3-26-13; paragraphs (b),
(c), and (f) EXPIRED: 2-23-14
New. #10903, eff 8-5-15
Ph 704.07 Return of Drugs and Devices.
(a)
Except as provided in Ph 704.07(b), no drug, prescription, device,
sickroom supply or item of personal hygiene which has left control of the
pharmacist or pharmacy and is returned to the pharmacy shall be resold or
re-dispensed after such item has been taken from the premises by the patient or
the patient’s representative, subject to the pharmacist’s professional
judgement.
(b)
Exceptions to Ph 704.07 (a) shall include:
(1) Orthopedic appliances;
(2) Crutches;
(3) Canes;
(4) Wheelchairs;
(5) Hospital beds;
(6) Bed rails;
(7) Trapezes;
(8) Other durable equipment that can be properly
sanitized; and
(9) Medications dispensed in unit-dose packaging
to institutionalized patients.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; paragraph (a)
EXPIRED: 2-1-07; paragraph (b) EXPIRED:
3-26-13
New. #10903, eff 8-5-15
Ph 704.08 Prescription Pick-up and Delivery.
(a) No person licensed under the provisions of
RSA 318, shall enter into or participate in any arrangement or agreement
whereby prescriptions may be left at, picked up from, accepted by, or delivered
to any store, shop or location not licensed as a pharmacy.
(b) This section shall not prohibit a licensee
from picking up prescriptions or delivering prescribed medications at the residence of the patient, or directly
to the patient at his/her workplace, or at the institution in which the patient
is confined, by means of an employee or by use of a common carrier.
(c) In situations where it is in the best
interest of the patient due to behavioral health issues or homelessness a
licensee may deliver the prescriptions to an authorized party for distribution
to the patient.
(d) Drugs with special handling or storage
requirements that will be administered by the practitioner may be delivered
directly to the practitioner’s office such as radio pharmaceuticals or frozen
Immunizations.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.09 Dispensing Adulterated or Misbranded Drugs. A pharmacist shall not dispense or sell to
the public any drug which is adulterated or misbranded. After notice and opportunity for a hearing, a
pharmacist who is found by the board to have knowingly dispensed or otherwise
sold for consumption an adulterated or misbranded drug, shall be subject to
disciplinary action according to RSA 318:29.
Source.
#1639, eff l1-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.10 Out-of-State Prescriptions. Prescriptions written by physicians in a
state other than
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.11 Pharmacist-in-Charge/Corporate Entity Requirements/Duties.
(a) Pharmacists looking to
serve as a Pharmacist-in-Charge (PIC) shall:
(1) Have worked as a pharmacist
for a minimum of 2 years post-graduation;
(2) Complete and pass with a
minimum of 80% an exam designed by the board to assess the knowledge of the
candidate in regard to their responsibilities as PIC; and
(3) Work a minimum of 20 hours
per week at the location where he/she serves as PIC except when absent due to
scheduled vacation or other authorized leave.
(b) Pharmacist in charge duties
shall include:
(1) Responsibility for the
control of all drugs issued or dispensed in the pharmacy where he/she
practices;
(2) Ensuring written policies and procedures for the procurement,
storage, compounding and dispensing of drugs are in place;
(3) Ensuring that all staff pharmacists
are familiar with and in compliance with the established policies and
procedures;
(4) Establishing and
supervising the recordkeeping system for the purchase, sale, possession,
storage, and repackaging of drugs;
(5) Maintaining the security of
the prescription department and its contents;
(6) Determining who will have
keys and access to the pharmacy with the exception of security personnel;
(7) Establishing quality
assurance guidelines to ensure the medication dispensed is in conformance with
the prescription received;
(8) Prohibiting the presence of
adulterated or misbranded drugs in the pharmacy;
(9) Ensuring compliance with
the provisions of RSA 318 and RSA 318-B and any other state or federal
pharmacy-related laws or rules;
(10) Supervising personnel in the prescription department; and
(11) Ensuring all personnel
involved in the preparation and dispensing of prescriptions are properly
licensed or registered with the board.
(c) Pharmacists may serve as a pharmacist-in-charge for a maximum of 2 pharmacies,
providing that one of these pharmacies shall be in an institution requiring the
services of a pharmacist only on a part-time basis.
(d) The corporate entity or permit holder shall
be responsible for the following:
(1) Written policies and
procedures for the procurement, storage, compounding and dispensing of drugs;
(2) Ensuring that all staff
pharmacists are familiar with and in compliance with the established policies
and procedures;
(3) Determining which security
personnel will have keys and access to the pharmacy and inform the pharmacist
in charge;
(4) Establishing procedures and
policies to ensure the security of the pharmacy department when a pharmacist is
working alone and needs to leave the licensed area for counseling,
immunizations, lunch or rest room breaks;
(5) Providing online access to
the
(6) Assuming all the
responsibilities of the pharmacist in charge in an interim period when the
pharmacist in charge has been vacated unexpectedly; and
(7) Supplying adequate staffing
to assist the board of pharmacy during scheduled routine inspections to assist
with the retrieval of records when hard copy records are not maintained
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10457, eff
11-1-13; ss by #10903, eff 8-5-15
Ph 704.12 Termination of Pharmacist-in-Charge Notice. Whenever a pharmacist-in-charge shall cease
performing that function, that pharmacist-in-charge shall notify the board in
writing of the date upon which the cessation of that function is
effective. That pharmacist-in-charge
shall remain responsible for compliance, in the pharmacy in which he or she was
the pharmacist-in-charge, with all pharmacy related statutes and rules until
the effective date of termination.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.13 Termination of Pharmacist-in-Charge -
Inventory. Whenever a
pharmacist-in-charge shall cease performing that function in a pharmacy, the
new pharmacist-in-charge shall, within 3 days, cause to be completed a written
inventory of all controlled substances located in that pharmacy. The record of that inventory shall be
retained in the pharmacy for a minimum of 2 years.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.14 Prescription Refill Limitations.
(a)
Prescriptions bearing "PRN", "Ad lib", or other
similar prescription refill designation permitting the pharmacist to refill the
prescription as needed by the patient, shall be refilled only in keeping with
the number of doses ordered and according to the directions for use, and in no
instance shall such prescription be refilled beyond one year from the date of
issue. If additional medication is
needed thereafter, the original prescription shall be voided and a new
prescription obtained.
(b) No prescription containing either specific or
"PRN" refill authorization shall be refilled when the pharmacist has
knowledge that the prescribing practitioner ceases to practice due to:
(1) License suspension or revocation;
(2) No longer maintaining a valid license;
(3) Prescribing limitations placed on a
practitioner's license by any state or federal licensing agency which impact on
certain previously refillable prescriptions; or
(4) Death.
(c)
Notwithstanding (a) and (b) above, the pharmacist may dispense an
additional refill supply according to the provisions of Ph 704.15.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a) and (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (c) EXPIRED: 2-1-07; paragraphs (a) and (b) EXPIRED: 3-26-13
New. #10685, EMERGENCY, eff 10-6-14, EXPIRED:
4-6-15
New. #10903, eff
8-5-15
Ph 704.15 Prescription Refill - Interim Supply. A pharmacist may refill a prescription drug order, including controlled substances
listed in Schedules III, IV and V, without the authorization of the prescribing
practitioner, provided that:
(a)
A failure to refill the prescription might result in an interruption of
a therapeutic regimen or create patient suffering;
(b)
The pharmacist is unable to contact the practitioner due to:
(1) A natural or man-made disaster has occurred
which prohibits the pharmacist from being able to contact the practitioner; or
(2) The practitioner’s office being closed
without a practitioner on call;
(c)
The quantity of prescription drug dispensed does not exceed a 30 day
supply for maintenance medications;
(d)
The pharmacist informs the patient or the patient's agent at the time of
dispensing that the interim supply shall be final and that authorization by the
practitioner shall be required for future refills;
(e)
The pharmacist shall inform the prescribing practitioner of the limited
emergency supply, provided to the patient, at the earliest reasonable time; and
(f) The pharmacists exercises professional
judgement in refilling the prescription drug order.
Source.
#6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a), (b), (d), and (e) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
intro. paragraph and (c) EXPIRED:
2-1-07; paragraphs (a), (b), (d), and (e) EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 704.16 Acts Prohibited. Splitting
fees, making rebates, or sharing money received for pharmaceutical services, or
the donation of and/or the use of equipment with other health practitioners or
with health institutions providing patient care shall be deemed by the board to
be contrary to the best interests of the patient, and shall therefore be
prohibited.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
PART Ph 705 STORAGE OF DRUGS
Ph 705.01 Prescription Drugs. All prescription drugs shall be stored in an
area which is under the immediate control of a pharmacist and not accessible to
unauthorized persons.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-15-15 (from Ph 705.02)
Ph 705.02 Emergency Drug Kits for Long Term Care
Facilities/Specialized Care Facilities.
(a) "Emergency drug kit" means a select
supply of drugs and/or biologicals located at the licensed institution for the
immediate administration to patients/residents upon the order of a practitioner
as set forth in rules adopted under RSA 151.
(b) “Automated electronic emergency drug kit”
means an automated medication storage system for the immediate administration
to patients/residents upon the order of a practitioner as set forth in rules
adopted under RSA 151.
(c) “Automated medication dispensing system”
means a computerized drug storage device or cabinet designed for use in long
term care facilities and other health care institutions.
(d) The placement of controlled substances in
emergency drug kits in non-federally registered long term care
facilities/specialized care facilities shall be deemed to be in compliance with
the Comprehensive Drug Abuse Prevention and Control Act of 1970 provided that:
(1) Controlled substances shall be stored in the
emergency drug kit as deemed necessary and jointly approved by the pharmacist
in charge and the consultant pharmacist, medical director and the director of
nursing services;
(2) The source from which controlled substances
for emergency drug kits are obtained shall be a DEA registered hospital,
clinic, pharmacy or practitioner;
(3) Controlled substances in emergency drug kits
shall be limited to a maximum of 16 separate drug entities with not more than 8
single use containers of each drug entity;
(4) The emergency drug kit containing controlled substances
shall be closed with a tamper proof seal and kept in a locked medication room,
cart or closet;
(5) Only the director of nursing services,
registered nurse on duty, licensed practical nurse on duty, pharmacist or
practitioner shall have access to controlled substances stored in an emergency
drug kit;
(6) Controlled substances in emergency drug kits
shall be administered to patients only by authorized personnel and only as
expressly authorized by an individual practitioner and in compliance with the
provisions of 21 CFR 1306.11 and 1306.21;
(7) A usage record shall be contained in the
emergency drug kit for each separate drug included which shall be completed by
the nursing staff when using any controlled substance or substances from the
kit;
(8) The pharmacist shall receive and file for 2
years a copy of all completed usage records;
(9) When the emergency drug kit is opened:
a. The pharmacist shall be notified by the
facility within 24 hours; and
b. Shift counts shall be done by the nursing
staff on all controlled substances until resealed by the consultant pharmacist;
(10) Shift counts of the controlled substances
contained in the emergency kit shall not be required when the kit is sealed;
(11) The pharmacist shall check the controlled
substances in the emergency drug kit at least monthly and so document inside
the kit; and
(12) The placement of controlled substances in
emergency drug kits shall be only upon the written authorization of the board
of pharmacy.
(e)
Automated electronic emergency drug kits shall meet the following
conditions:
(1) Real time electronic communication to the
provider pharmacy;
(2) For access, employ at least but not limited
to:
a. Bio-Identification; and
b. Unique individualized password protections
assigned by the provider pharmacy;
(3) Automatically generate notice to the provider
pharmacy whenever the kit is accessed and provide at least the following
information:
a. Name of individual accessing the kit;
b. Date and time the kit was accessed;
c. Name, strength and quantity of drug removed;
and
d. Name of patient for whom the drug was
administered; and
(4) Upon restocking the automated electronic
emergency drug kit the following conditions shall be met:
a. The filling/restocking of an automated
electronic emergency drug kit shall be performed by a licensed pharmacist,
physician, physician assistant, advanced practice nurse, registered nurse and
registered pharmacy technician.
(5) “Automated medication dispensing system”
means a computerized drug storage device or cabinet designed for use in long
term care facilities and other health care institutions. An automated medication dispensing system may
be used as an electronic emergency drug kit provided the system performs
operations or activities relative to the storage, packaging, dispensing and
distribution of medications, and which tracks and maintains a record of
transaction information;
(6) Automated emergency drug kits shall be
allowed as set forth in rules adopted under RSA 151;
(7) Non-controlled legend drugs may be stored in
the emergency drug kit in quantities deemed
necessary and jointly approved by the pharmacist in charge of the provider
pharmacy, consultant pharmacist, medical director and the director of nursing
services; and
(8) The placement of controlled substances in
automated electronic emergency drug kits in non-federally registered long term
care facilities and other health care institutions shall be deemed to be in
compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970
provided that:
a. Controlled substances shall be selected and
stored in the automated electronic emergency drug kits in quantities deemed
necessary and jointly approved by the pharmacist in charge and the consultant
pharmacist, medical director and the director of nursing services;
b. Only the director of nursing services,
registered nurse on duty, licensed practical nurse on duty, pharmacist,
registered pharmacy technician or practitioner shall have access to controlled
substances stored in an automated electronic emergency drug kit;
c. Controlled substances in automated electronic
emergency drug kits shall be administered to patients only by authorized
personnel and only as expressly authorized by an individual practitioner and in
compliance with the provisions of 21 CFR 1306.11 and 1306.21; and
d. When an automated electronic emergency drug
kit is utilized, notification of usage shall be reported in accordance with
Ph705.02 (e) (3).
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-15-15 (formerly Ph 705.03)
PART Ph 706 PHARMACEUTICAL CARE STANDARDS
Ph 706.01 Patient Records.
(a)
A patient record system shall be maintained by all pharmacies for
patients for whom prescriptions are dispensed.
The patient record system shall provide for the immediate retrieval of
information necessary for the dispensing pharmacist to identify previously
dispensed drugs at the time a prescription is presented for dispensing.
(b)
The pharmacist or supportive personnel shall make a reasonable effort to
obtain, record, and maintain the following information:
(1) The full name of the patient for whom the
drug is intended;
(2) The address and telephone number of the
patient;
(3) The patient's age or date of birth;
(4) The patient's gender;
(5) A list of all prescription drug orders obtained
by the patient at the pharmacy maintaining the patient record during the 12
months immediately preceding the most recent entry showing:
a. The name of the drug or device;
b. The prescription number;
c. The name and strength of the drug;
d. The quantity and date received; and
e. The name of the prescriber; and
(6) Pharmacist comments relevant to the
individual's drug therapy, including any other information peculiar to the
specific patient or drug.
(c)
The pharmacist shall make a reasonable effort to obtain from the patient
or the patient's agent, and record, any known:
(1) Allergies;
(2) Drug reactions;
(3) Idiosyncrasies; and
(4) Usage of other drugs, including
over-the-counter drugs, or medical devices currently being used by the patient.
(d)
A patient record shall be maintained for a period of not less than 12
months from the date of the last entry in the profile record. This record shall be a hard copy or a
computerized form.
Source.
#5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss by
#5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED:
2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 706.02 Prospective Drug Review.
(a)
A pharmacist shall review the patient record and each prescription
presented for dispensing for purposes of identifying:
(1) Over-utilization or under-utilization;
(2) Therapeutic duplication;
(3) Drug-disease contraindication;
(4) Drug-drug interactions;
(5) Incorrect drug dosage or duration of drug
treatment;
(6) Drug-allergy interactions; and
(7) Clinical abuse or misuse.
(b)
Upon recognizing any of the above, the pharmacist shall take appropriate
steps to avoid or resolve the problem which might include consultation with the
prescriber.
Source.
#5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss by
#5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED:
2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 706.03 Patient Counseling.
(a) Pharmacists shall be required to make a
reasonable attempt to counsel the patient or patient’s caregiver in person or
by telephone when dispensing the first fill of a new prescription in the
following situations:
(1) Prescriptions for patients under the age of
13;
(2) Concentrated medications;
(3) Anticoagulant/antiplatelet medications;
(4) Endocrine medications; and
(5) Anti-infective medications.
(b) Pharmacists, pharmacy interns or
(c)
In situations where there is no direct contact with the patient or
caregiver including but not limited to nursing homes, assisted living or
prisons, supplemental printed information shall be provided.
(d)
Upon receipt or delivery of a new prescription, where mandatory
counseling is not required, and following a review of the patient's record, a
pharmacist or his/her designee, shall orally offer to discuss matters which
will enhance or optimize drug therapy with each patient or caregiver of such
patient.
(e)
Patient counseling shall:
(1) Be by the pharmacist or pharmacy intern and
in person, whenever practicable, or by telephone; and
(2) Include appropriate elements of patient
counseling, such as the following:
a. The name and description of the drug;
b. The dosage form, dose, route of
administration, and duration of drug therapy;
c. Intended use of the drug and expected action;
d. Special
directions and precautions for preparation, administration, and use by the
patient;
e. Common side or
adverse effects or interactions and therapeutic contraindications that might be
encountered, including their avoidance, and the action required if they occur;
f. Techniques for self-monitoring drug therapy;
g. Proper storage;
h. Prescription refill information;
i. Action to be taken in the event of a missed
dose; and
j. Pharmacist comments relevant to the
individual's drug therapy, including any other information peculiar to the
specific patient or drug.
(f)
Alternative forms of patient information may be used to supplement
patient counseling. Examples shall
include written information leaflets, pictogram labels, or video programs.
(g)
Patient counseling, as described above shall not be required for
inpatients of penal institutions or inpatients of a hospital or long term care
facility where other licensed health care professionals are authorized to
administer the drugs and drug therapy reviews are conducted on a routine basis.
(h)
A pharmacist shall not be required to counsel a patient or agent when
the patient or agent refuses such consultation.
However, failure to document the patient's refusal of counseling shall
imply that counseling was provided.
Source.
#5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss by
#5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED:
2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
PART Ph 707 DISPOSAL AND DESTRUCTION OF CONTROLLED DRUGS
Ph 707.01 Controlled Drug Destruction. Any person authorized to possess controlled
drugs and desiring to dispose of such drugs may request destruction of the
drugs by the board or request an authorization from the board to destroy such
drugs.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10903, eff 8-5-15
Ph 707.02 Request for Destruction.
(a)
A request to destroy controlled drugs shall be in writing and signed by
a duly authorized person as defined in (b) below. The itemized written request shall be
conveyed to the board office and the destruction process shall not proceed
until the authorization is received by the person who made the request.
(b)
Personnel authorized to sign a request for controlled drug destruction
shall include:
(1)
Pharmacist-in-charge, as defined in RSA 318:1, X, practitioners or their designated
agents;
(2) Administrators of health care institutions or
their designated agent or agents;
(3) Agents of the superior court;
(4) County attorneys;
(5) Director,
(6) Chiefs of local police departments; and
(7) Director,
(c)
The written request shall not be required when a consultant pharmacist,
acting as an agent of the pharmacy board, destroys controlled drugs in a
licensed long-term care or specialized care facility.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (a), paragraph (b) intro., subparagraphs (b)(2)-(b)(7), and
paragraph (c) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paragraphs (b)(2)-(b)(6) EXPIRED: 3-26-13; paragraphs (a), (b) intro.,
(b)(1), (b)(7), and (c) EXPIRED: 2-23-14
New. #10903, eff 8-5-15
Ph 707.03 Board Authorized Controlled Drug
Destruction.
(a)
A consultant pharmacist to a nursing home, group home or assisted living
facility shall be designated an agent of the pharmacy board for the sole
purpose of destroying controlled drugs at the licensed home or homes for which
he or she serves as consultant by filing a written request at the board office,
identified in Ph 103.03. The written
request shall be on the facility’s letterhead, shall identify the pharmacist as
the home's consultant pharmacist, and shall be signed by both the administrator
of the facility and the consultant pharmacist.
(b) Once authorization is obtained:
(1) A record of the controlled drugs destroyed
shall be made on form # Ph 558 (revised 7/2015) obtained at the board office,
identified in Ph 103.03; and
(2) Copies of form # Ph 558 (revised 7/2015)
shall be distributed as follows:
a. The original shall be sent to the board
office;
b. A copy shall be maintained on the premises
where the destruction occurred for a period of 4 years; and
c. A copy shall be retained by the consultant
pharmacist/agent making the destruction.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (c) and (d) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd by
#8572, eff 2-23-06; paragraph (a) EXPIRED: 2-1-07; paragraph (b)-(f) EXPIRED:
2-23-14
New. #10903, eff 8-5-15
Ph 707.04 Controlled Drug Destruction by the Board
of Pharmacy.
(a)
The destruction of controlled drugs by the board shall occur on the
premises of the practitioner, institution or agency requesting the destruction.
Destruction shall be carried out by any person so designated as the authorized
agent of the board provided that such agent as well as the person requesting
destruction or his or her designee are present during the entire destruction
process.
(b)
The practitioner or person requesting destruction or their designee
shall also be present and shall witness destruction of the controlled drugs.
(c)
Witnesses may include:
(1) The practitioner or practitioner’s agent,
including a pharmacist;
(2) The administrator or assistant administrator;
and
(3) The director of nursing, nursing supervisor
or charge nurse.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83;;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 707.05 Record of Controlled Drug Destruction.
(a)
A record of the drugs destroyed shall be made on federal form DEA-4l,
"Registrant's Inventory of Drugs Surrendered" in accordance with 21
CFR 1307.21, 22. This form may be
obtained from the board office, identified in Ph 103.03, or from an office of
the Drug Enforcement Administration.
(b)
The data recorded on form DEA‑41 shall include at least the:
(1) Name, strength, and quantity of the drugs
destroyed;
(2) Date, time and place of destruction;
(3) Manner of destruction; and
(4) Signature and
title of persons destroying and witnessing destruction of the controlled drugs.
(c)
Copies of the form designated in Ph 707.05(a) shall be distributed as
follows:
(1) The original shall be maintained at the board
office, identified in Ph 103.03; and
(2) A copy shall be retained on the premises of
the practitioner, agency, court, or person requesting the destruction.
(d)
A copy of the record of those drugs destroyed shall be maintained on the
premises where the destruction occurred for a period of 4 years.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (b), and (d) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraph (c) EXPIRED: 2-1-07; paragraphs (a), (b), and (d) EXPIRED:
3-26-13
New. #10903, eff 8-5-15
Ph 707.06 Exemption. Nothing contained in part Ph 707 shall
require the board to destroy any drug if the board determines that to do so
would impair law enforcement efforts or the health or safety of any person.
Source.
#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss
by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
PART Ph 708 TERMINATION OF A PHARMACY OPERATION
Ph 708.01 Notification of Closing.
(a)
Written notification to the board shall be filed at least 15 days prior
to the date of the anticipated closing.
This notice shall indicate the date of closing and the planned
disposition of legend drugs including controlled substances and all records
thereof.
(b)
Written notification to DEA shall be filed at least 15 days prior to the
date of the anticipated closing.
Compliance with DEA instructions relative to closing procedures shall be
required.
(c)
At least 5 days prior to the anticipated closing a notice shall be
conspicuously posted at the pharmacy indicating the date of closing and the
future location of the prescription files.
This notice shall be posted for a period of at least 30 days unless
removed by the landlord or a new tenant.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 708.02 Disposition of Drugs/Records.
(a)
Security of the pharmacy shall be maintained while there is a supply of
legend drugs including controlled substances on the pharmacy premises. Stable, unopened containers of legend drugs
including controlled drugs may be returned by the pharmacy to the
wholesaler/manufacturer.
(b)
At the time of closing, the remaining supply of controlled substances
may be sold or given to another pharmacy provided that:
(1) The transfer of schedule II substances shall
comply with 21 CFR 1307.14 and 21 CFR 1305.06 by means of a properly executed
federal DEA #222 Form;
(2) The transfer of schedules III, IV, and V are
made by invoice with copies to each party and the board; and
(3) Prescription files, executed DEA #222 forms,
biennial DEA inventories, applicable invoices, the balance of stock of all
controlled substances, and the final printouts required by Ph 703.05(r)(2),
shall be transferred as a package.
(c)
At the time of closing, in addition to the electronic file transfer of
the prescription records the closing pharmacy shall:
(1) Provide an up-to-date hard-copy printout of
all non-controlled drug prescriptions stored in the automated system and a
printout of all controlled drug prescriptions for the current 2 year period as
part of the final records of that pharmacy;
(2) In lieu of such printout, an electronic
back-up of the prescription records for the last 2 year may be provided on electronic media; and
(3) In the event
that the pharmacy files are not sold to another pharmacy, the closing pharmacy
shall make provision for these records to be available to any nearby pharmacy.
(d) If, in the interest of public health and
safety, the board determines that after closure of the pharmacy a lack in the
security, according to Ph 702.04, of the prescription drugs including
controlled substances exists, the licensee shall immediately surrender to the
board all prescription drugs including controlled substances and forms and
invoices thereof. The drugs so held
shall be inventoried, packaged, sealed and stored at the expense of the
licensee in a place determined by the board to be appropriately secure. The licensee shall have 60 days after the
effective date of the closing to make arrangements for the lawful sale or other
disposition of these drugs. Lawful sale
and/or disposition of these drugs shall be to a duly licensed person authorized
to possess and store prescription drugs including controlled substances. Failing compliance within this 60-day period,
such drugs shall then be surrendered to the board for destruction.
(e)
Before disposing of any merchandise in the pharmacy, the owner and
pharmacist-in-charge shall submit the licensed premises to an inspection by a
representative of the board to certify that all prescription drugs including
controlled substances have been secured.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (b), (c) intro., (c)(1)-(2), and (e) EXPIRED:
2-5-04; amd by #8316, eff 3-26-05; paragraphs (c)(3) and (d) EXPIRED: 2-1-07;
paragraphs (a), (b), (c) intro., (c)(1)-(2), and (e) EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 708.03 Final Written Report. No later than 20 days after a pharmacy
closing, the licensee shall:
(a)
Return the pharmacy permit to the board;
(b)
Notify the board that all signs and symbols indicating the presence of a
pharmacy have been removed;
(c)
Notify the board that all labels and blank prescriptions have been
destroyed;
(d)
Notify the board that the DEA license and all blank DEA #222 forms have
been returned to the regional director of the DEA;
(e)
File with the board, a copy of the dated inventory of all controlled
substances transferred including the name and address of the person(s) to whom
these drugs and applicable records were transferred; and
(f)
In the case of an involuntary closing, file with the board the final
disposition of the drugs as soon as possible after the transfer is made.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
PART Ph 709 INSTITUTIONAL PRACTICES
Ph 709.01 Definitions.
(a)
“Automated medication supply system” means an electronically controlled
system that performs operations or activities relative to the storage and
distribution of medications for administration and which collects, controls,
and maintains all transaction information.
(b)
“Electronic identifier”, for purposes of paragraph (a) above, means a
unique security code or other identifier which specifically identifies the
person entering information into a data processing system.
Source.
#2260, eff 01-05-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06;
ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.02 Licensing and Practice Standards.
(a)
A pharmacy permit shall be required for each institution with an
on-premise pharmacy. Such permit shall be
issued to a pharmacist-in-charge, who shall be licensed in the state of
(b)
If an institution does not have a pharmacy on its premises, it may enter
into an agreement with a pharmacy licensed to provide such services. Such
agreement shall be in writing and shall state the policy and procedures as
required by Ph 709. A copy of the
agreement shall be made available by the consultant pharmacist to the board
upon request. The consultant pharmacist
shall be responsible for the maintenance of all records and the compliance with
state and federal laws and rules governing the practice of pharmacy.
(c)
An institutional license shall permit the pharmacy to dispense
medications to in-patients of the institution, staff or employees of the
institution, interim supplies of medication to outpatients in emergency
situations and home infusion therapy to contractual patients not requiring
hospitalization. If a pharmacist is on
the premises, outpatient prescription services may be provided by the pharmacy,
on a one-time, no-refill basis, to an ambulatory care patient and any patient
who is being discharged with medications related to the patient's
hospitalization. Labeling for all
outpatient prescriptions shall be according to RSA 318:47-a and RSA 318-B: 11.
(d)
Members of the board and/or their agents shall inspect the pharmacy,
drug room/medication room and all areas or departments of the facility where
drugs are stored, manufactured, compounded, dispensed or distributed to ensure:
(1) That adequate drug security and storage
requirements are met;
(2) That proper records are maintained; and
(3) That the facility is in compliance with all
local, state and federal drug and pharmacy laws and rules.
(e)
Those facilities obtaining prescription drugs only on individual
prescriptions for specific patients from an off-premise licensed pharmacy shall
not be exempt from inspection.
(f)
Each institution shall have a pharmacy and therapeutics committee or a
comparable committee of its medical staff. This committee shall be composed of
representatives of the medical staff and the pharmacist-in-charge, or a
licensed staff pharmacist designated by the pharmacist-in-charge, and
representatives of the administrative and nursing departments. The pharmacy representative shall be a voting
member of the committee and the committee shall meet at least twice a
year. The major functions of this
committee shall be to establish the written policies and procedures governing
the practice of pharmacy, use of drugs, drug specifications and drug
distribution.
(g)
An institutional pharmacy may dispense a generic or therapeutic
equivalent that has been approved by the pharmacy and therapeutics committee or
its equivalent only to in-patients of the institution, staff or employees of
the institution and their dependents, or interim supplies of medication to
outpatients in emergency situations.
(h)
When applicable, the corporate officer, or the officer’s replacement,
who signs the pharmacy permit shall be held accountable, along with the
pharmacist-in-charge, regarding compliance to federal, state, and local laws
related to the practice of pharmacy.
Both individuals shall be held accountable regarding compliance as
required by the
(i)
When applicable, the corporate officer, or the officer’s replacement,
who signs the pharmacy permit, and the pharmacist-in-charge, shall comply with
federal, state and local laws related to the practice of pharmacy.
Source.
#4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a), (b), (d), (e), and (f) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; amd by #8572, eff 2-23-06; paragraphs (c) & (h) EXPIRED: 2-1-07;
ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.03 Environment.
(a)
The institutional pharmacy shall be enclosed, lockable and alarmed.
(b)
The institutional pharmacy shall have adequate space necessary for the
storage, compounding, labeling, dispensing and sterile preparation of drugs
prepared in the pharmacy.
(c)
The institutional pharmacy shall be arranged in an orderly fashion and
shall be kept clean.
(d)
A sink with hot and cold running water shall be available to all
pharmacy personnel.
(e)
The institutional pharmacy shall have locked storage for schedule II
controlled substances and other controlled drugs requiring additional security.
(f)
The institutional pharmacy shall have designated areas for the storage
of flammable and caustic materials. Such areas shall meet the requirements set
by local and state fire laws.
(g)
The institutional pharmacy shall have a designated area for the
preparation of sterile products.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10225, eff
11-7-12; ss by #10903, eff 8-5-15; ss by #10903, eff 8-5-15
Ph 709.04 Drug Security.
(a)
Drugs stored in any area or department of the facility shall be plainly
labeled and kept in a specifically designated, well-illuminated cabinet, closet
or storage area and shall be accessible only to authorized personnel.
(b)
When controlled drugs are stored in authorized areas other than in the
pharmacy, special locked storage for all controlled substances requiring
additional security shall be used.
(c)
When using an automated medication supply system, the
pharmacist-in-charge or designee shall have the responsibility for developing a
secure system to assign, discontinue or change personnel access codes.
(d)
A pharmacist or registered pharmacy technician under the direction of a
pharmacist shall visit and create a retrievable record, at least monthly, all
areas or departments of the institution where drugs, biologicals,
pharmaceutical chemicals or other pharmaceutical preparations are stored to
ensure that they are properly labeled, have not reached their expiration date
and show no signs of deterioration. Any
substance not conforming to these standards shall be removed from stock.
(e)
A retrievable record of each monthly inspection specified in (d) above
shall be maintained in the pharmacy for at least 2 years and shall be available
to the board upon request.
(f)
The pharmacist-in-charge shall ensure that the areas specified in (d)
above are in compliance with federal and state drug laws relative to security,
drug distribution and product tampering.
(g)
The pharmacist-in-charge shall develop a distribution system which shall
prevent the illicit diversion of drugs.
(h)
Discrepancies shall be reported to the pharmacy within 24 hours and
resolved within 72 hours. Missing or
unaccounted controlled drugs shall be reported to the NH board and Drug
Enforcement Agency (DEA) as specified by 21 CFR § 1301.76-b.
(i)
When an emergency drug kit other than regulated by Ph 705.03, containing
controlled substances is opened, shift counts shall be done by the nursing
staff on all controlled substances until resealed by a pharmacist.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff
2-23-06; ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.05 Dispensing Practices.
(a)
Drugs shall be dispensed only by or in the presence of and under the
supervision of a pharmacist, or prescriber in compliance with local, state and
federal pharmacy-related laws and rules.
Upon the written order of a prescriber a nurse may leave a properly
labeled container of any non-controlled drug at the patient's bedside. A
licensed nurse shall not dispense or compound drugs except as permitted by RSA
318:42.
(b)
The pharmacy shall dispense medications pursuant of an order from a
prescriber. Drugs shall be provided to patients in institutions only on the
order of a practitioner legally authorized to write prescriptions. No change in
the order for drugs shall be made without the approval of a practitioner
qualified to write prescriptions.
(c)
Each order pursuant to (b) above shall include at least the:
(1) Patient's name and location;
(2) Date of the order;
(3) Name and dosage of the drug;
(4) Directions; and
(5) Signature of the prescriber or licensed
health care professional receiving the order.
(d)
Written policies and procedures shall be adopted which establish the method
utilized in the procurement, storage and distribution of drugs in all areas or
departments of the facility, and which are consistent with state and federal
pharmacy laws and rules.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by#8572, eff 2-23-06;
ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.06 Access to the Pharmacy.
(a)
Only a pharmacist shall open and close the pharmacy. The pharmacist-in-charge of each
institutional pharmacy shall establish written policies identifying specific
situations when pharmacy technicians may be present in the pharmacy in the
absence of a licensed pharmacist.
(b)
In the absence of a pharmacist and in accordance with RSA 318:38,I
licensed nurses, designated for this purpose by the pharmacist-in-charge, may
obtain from the pharmacy or night cabinet such drugs as needed in an emergency
when these drugs are not available in floor stock supplies.
(c)
The authorized nurse may enter the pharmacy area and remove the
following:
(1) A drug in its original container or a drug
prepackaged for use within the facility subject to these rules; or
(2) An emergency supply of a drug from the
original container to be administered to a specific patient.
(d)
The authorized nurse shall leave a copy of the physician's order in the
pharmacy or night cabinet and on a suitable form record the following:
(1) Name and strength of the drug taken;
(2) Dosage form taken;
(3) Quantity taken;
(4) Time and date of withdrawal;
(5) Patient name and/or location, where
applicable and; and
(6) Nurse's signature.
(e)
The nurse shall leave with the record the bulk container from which the
medication was taken or a representative sample of the unit-dose medication.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10225, eff
11-7-12; ss by #10903, eff 8-5-15
Ph 709.07 Drug Control in Ambulatory Patient
Treatment Areas.
(a)
In the ambulatory patient treatment areas, a medical practitioner may dispense
drugs for the immediate needs of the patient, not in excess of a 72-hour
supply, except that, for Schedule II controlled substances, a maximum of
48-hour supply shall be allowed, if permitted by the institution. The drug
container shall be properly labeled.
(b)
If a licensed pharmacist is on the premises, that pharmacist may fill
one time, full amount, non-refillable prescriptions for patients for
medications related to the ambulatory patient treatment visit.
(c)
A readily retrievable record shall be made of all administrations and
dispensing of controlled drugs in the ambulatory patient area.
(d)
This record shall include:
(1) Name and address of the patient;
(2) Name of the medical practitioner;
(3) Name, strength and quantity of the drug(s);
(4) Date of administration or dispensing; and
(5) Signature or electronic identifier, as
defined in Ph 709.01(b), of the agent removing the drug(s) from the inventory.
Source.
#2260, eff 01-05-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraph (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paras. (a) & (c) EXPIRED:
2-1-07; ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.08 Investigational Drugs. Investigational drugs for research shall be
used only under the supervision of the principal investigator and shall be
approved by an appropriate medical staff committee. Such drugs shall be
controlled by the pharmacy and shall be properly labeled. A central unit, which may be the pharmacy,
shall be established where essential information on investigational drugs is
maintained. Nurses shall be given basic pharmacologic information about the
drug before administering.
Source.
#2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06
ss by #10225, eff 11-7-12; ss by #10903, eff 8-5-15
Ph 709.09 Purchase of Drugs.
(a)
The pharmacist-in-charge, with the consent of the institution's pharmacy
and therapeutics committee or comparable committee of its medical staff shall
be responsible for the quality of all drugs, biologicals and pharmaceutical
chemicals.
(b)
Purchasing of drugs, pharmaceuticals, biologicals, intravenous and
irrigation fluids shall be subject to approval of the pharmacist-in-charge with
the consent of the institution's pharmacy and therapeutic committee or
comparable committee of its medical staff.
(c)
Radiopharmaceuticals, blood products, radiopaque media and medical
devices may be exempted from the approval and/or control of the
pharmacist-in-charge by the institution's pharmacy and therapeutics committee.
Source.
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10225, eff
11-7-12; ss by #10903, eff 8-5-15
PART Ph
710 ADMINISTRATIVE FINES
Ph 710.01 Liability for Administrative Fines. Persons subject to the disciplinary authority
of the board and other persons
subject to administrative fines or penalties under RSA 318:29, IV shall, at the
discretion of the board, after notice and an opportunity to be heard, be
assessed fines and/or penalties as authorized under RSA 318:29, IV.
Source. #4600, eff 8-1-89;
ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED:
3-26-13; ss by #10903, eff 8-5-15
Ph 710.02 Severity of Fine.
(a)
The decision to impose a fine and the amount of such fine shall depend
on:
(1) The severity of harm to the public posed by
the violation(s);
(2) The number of concurrent and/or repeated
violations; and
(3) The frequency of violations committed by the
particular licensee, permit holder, or other person.
(b)
When no violation of the same type has occurred within the 5 years
preceding the board's notice to the respondent, the fine assessed shall not
exceed $1,000 per violation upon the licensee and/or $2,000 per violation upon
the permit holder.
(c)
When a single disciplinary infraction of the same type has occurred
within the 5 years preceding the board's notice to the licensee, the fine
assessed shall not exceed $2,000 per violation upon the licensee and/or $3,000
per violation upon the permit holder.
(d)
When more than one disciplinary infraction of the same type has occurred
within the 5 years preceding the
board's notice to the licensee, the fine assessed shall not exceed $3,000 per
violation upon the licensee and/or $5,000 per violation upon the permit holder.
(e)
In the case of continuing violations, a separate fine shall be assessed
for each day the violation continues, but the total amount of the fine and the licensee's promptness and
cooperativeness in ceasing the prohibited conduct in question shall be
considered in assessing the daily fines.
(f)
In all cases, the board shall consider:
(1) The nature of the offense;
(2) The purpose of the rule or statute violated;
(3) The licensee's state of mind at the time the
offense occurred;
(4) The potential harm to the public health;
(5) The deterrent effect upon other
practitioners;
(6) The licensee's willingness to cooperate with
the board;
(7) The cost to the board of any formal disciplinary
hearings which were necessary;
(8) The licensee's acknowledgment of his or her
wrongdoing; and
(9) The nature of any other disciplinary
sanctions imposed as a result of the offense in question.
Source. #4600, eff 8-1-89;
ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
CHAPTER
Ph 800 PHARMACY TECHNICIANS
Statutory
Authority: RSA 318:5-a, X, XI
PART Ph 801 PURPOSE AND SCOPE
Ph 801.01 Purpose and Scope. The provisions of this chapter shall apply to,
and impose duties upon, all pharmacy technicians holding registrations or
certifications issued by the board.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff 11-7-18
PART Ph 802 DEFINITIONS
Ph 802.01 Definitions. Except where the context makes another
meaning manifest, the following definitions shall apply:
(a) “Registered pharmacy technician” means a
person who is registered with the board, employed by a pharmacy, and who can assist in performing, under the
supervision of a licensed pharmacist, manipulative, nondiscretionary functions
associated with the practice of pharmacy and other such duties, subject to such
restrictions as the board has specified; and
(b)
“Certified pharmacy technician” means a pharmacy technician who has
become and who maintains national certification by taking and passing an exam
recognized by the board for the purpose of certifying technicians and who has
been certified by the board.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff
11-17-18
PART Ph 803 REQUIREMENTS FOR REGISTERED PHARMACY
TECHNICIANS
Ph 803.01 Registered Pharmacy Technician
Qualifications.
(a)
An applicant for a registered pharmacy technician shall:
(1) Be at least 16 years of age;
(2) Have a high
school or equivalent diploma, or be working to achieve a high school or
equivalent diploma;
(3) Not have been convicted of a drug or
pharmacy-related felony or misdemeanor or admitted to sufficient facts to
warrant such a finding; and
(4) Register with the
board within 15 days of start date of employment as a pharmacy technician, and
post such registration in the pharmacy within 30 days.
(b)
No person shall perform
the functions or duties of a pharmacy technician unless such person is
registered by the board.
Source. #7535, eff 7-25-01;
amd by #8572, eff 2-23-06; paras (a) & (b) EXPIRED: 7-25-09; paras. (c) and
(d) EXPIRED:
2-23-14
New. #10720, eff 11-22-14; ss by #12671, eff
11-17-18 (formerly Ph 807.02)
Ph 803.02 Application Procedures for Registered
Pharmacy Technicians.
(a) Registered pharmacy technician applicants shall complete and submit an “Initial
Application for Pharmacy Technician Registration” form (PT-1), or electronic
equivalent, for registration to the board that contains the following:
(1) Legal name, residence address, mailing
address, home or cell phone number, personal e-mail address, and social
security number of the applicant;
(2) Date and place of birth and gender of the
applicant;
(3) Name of current employer and the mailing
address, phone number, and e-mail address of employment site;
(4) Name of supervisor and pharmacy phone number;
(5) An indication as to whether or not the applicant
has been convicted of a drug or pharmacy-related felony or misdemeanor or
admitted to sufficient facts to warrant such a finding, and if yes, an
explanation, an explanation of the circumstances surrounding such a finding or
conviction;
(6) An indication as to whether the applicant has
ever voluntarily surrendered for disciplinary reasons a license, registration,
or certification to practice as a pharmacy technician in any jurisdiction and,
if so, an explanation of such surrender;
(7) An indication as to whether the applicant has
any felony convictions and, if so, an explanation of such convictions; and
(8) Applicant's signature and date.
(b)
The prescribed fee shall be $100, and shall be submitted with the
completed application form.
(c)
The “Initial Application
for Pharmacy Technician Registration” form PT-1 for registration of pharmacy
technicians in New Hampshire may be obtained from and shall be filed at the office of the board, identified in Ph
103.03.
Source. #12671, eff 11-17-18
PART Ph 804 REGISTERED PHARMACY TECHNICIAN RENEWALS
Ph 804.01 Renewal Requirements for Registered
Pharmacy Technicians.
(a)
All pharmacy technician registrations
shall expire biennially on March
31.
(b)
Applications for the renewal of a registration for a pharmacy technician
may be obtained from, and shall be filed at the office of the board, identified
in Ph 103.03.
(c) A pharmacy technician applying for renewal
shall do so online at https://nhlicenses.nh.gov/eGov/Login.aspx
by providing the following information:
(1) Legal name, residence address, mailing
address, personal e-mail address, and a mobile or home telephone number;
(2) License number and work email address of the
pharmacist-in-charge;
(3) Name and phone number of current employer and
address of employment site;
(4) Record of convictions of violations of
federal, state or local drug or pharmacy related laws or regulations; and
(5) Applicant’s signature and date.
(d) The
application and the prescribed fee of $100 shall be filed with the board no later
than March 15.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New.
#10720, eff 11-22-14; ss by #12671, eff 11-17-18 (formerly Ph 806.01)
PART Ph 805 ONGOING REQUIREMENTS FOR REGISTERED PHARMACY
TECHNICIANS
Ph 805.01 Change in Registration Information for
Registered Pharmacy Technicians.
(a)
The person to whom a pharmacy technician registration has been issued
shall, within 15 days of a change of address or location of employment, notify
the board of such changes.
(b)
The notice shall contain:
(1) Legal name of registrant;
(2) Address, phone number, and personal email
address of the registrant, including old and new, if applicable;
(3) Registrant’s registration number;
(4) Name of the pharmacy where employed including
former and current, if applicable; and
(6) All new violations of law, convictions,
fines, disciplines or any registration, certification, or license revocations
for violation of pharmacy-related drug laws or regulations in this or any other
state.
(c)
Failure to comply with Ph 805.01 shall constitute misconduct under RSA
318.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff
11-17-18
Ph 805.02 Penalty. Any registered pharmacy technician who
alters, forges, or intentionally falsifies, or causes to be altered, forged or
falsified, any information, documents, or records required to be kept or
submitted by this rule shall be subject to disciplinary action under RSA
318:29, II.
Source. #12671, eff 11-17-18
(formerly Ph 806.05)
PART Ph 806 REVOCATION, DENIAL, AND REINSTATEMENT OF
REGISTERED PHARMACY TECHNICIANS
Ph 806.01 Effect of Revocation and Denial for Registered
Pharmacy Technicians.
(a) The board shall refuse to issue a
registration or, after notice and hearing, shall revoke a registration whenever the board
finds by the preponderance of the evidence any of the following:
(1) That the applicant, or registrant, has
violated any of the provisions of RSA 318, RSA 318-B, or the board’s
administrative rules;
(2) That the applicant has been convicted of a
felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule or regulation;
(3) That the applicant has attempted to obtain a
pharmacy technician registration by fraudulent means;
(4) That the applicant is unable to engage in the
performance of pharmacy technician functions with reasonable skill and safety
by reason of illness, inebriation, misuse of drugs, narcotics, alcohol,
chemicals or any other substance, or as a result of any mental or physical condition;
(5) That another state has suspended, revoked, or
placed on probation the applicant’s license, permit, or registration to
practice as a pharmacy technician;
(6) That the applicant refused to appear before
the board after having been ordered to do so in writing; or
(7) That the applicant made any fraudulent or
untrue statement to the board.
(b)
The pharmacist on duty shall notify the board, in writing, within one
calendar day after becoming aware that a pharmacy technician has adulterated, abused, stolen or diverted
drugs.
(c)
The board shall reinstate
a revoked technician’s previous permit after review, provided that the reason
for revocation no longer exists or it is determined that there is no longer a
threat to public safety.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff
11-17-18
Ph 806.02 Reinstatement of a Registered Pharmacy
Technician. Registered pharmacy
technicians who either voluntarily or accidentally allow their registration to
lapse as of March 31 of the renewal year shall complete the following
procedures to reinstate their registration:
(a) Complete a reinstatement
application found on the board’s website at https://www.oplc.nh.gov/pharmacy/documents/technician-reinstatement.pdf (revised April
2018);
(b)
Submit the completed application and the prescribed fee to the board’s
office;
(c)
Submit any required documentation, as indicated on the form; and
(d)
Submit a signed and dated statement as to why the applicant did not
renew his or her pharmacy technician registration prior to expiration and
whether or not the applicant has practiced as a pharmacy technician since his
or her registration has lapsed.
Source. #7535, eff 7-25-01,
EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff
11-17-18
PART Ph 807 REGISTERED PHARMACY TECHNICIANS – STANDARDS
OF PRACTICE
Ph 807.01 Determination of a Registered Pharmacy
Technician’s Duties.
(a)
A pharmacy technician shall only perform such tasks and duties which are
prescribed by the permit holder or pharmacist-in-charge based upon the needs of
the pharmacy.
(b) A pharmacy technician’s duties may
be further limited by the pharmacist on duty or the supervising pharmacist.
(c)
Any training given under the direction of a pharmacist shall be
documented by the pharmacist-in-charge and be retrievable upon inspection.
Source. #7535, eff 7-25-01;
amd by #8572, eff 2-23-06; para (d) EXPIRED: 7-25-09; paras. (a)-(c) and (e)
EXPIRED:
2-23-14
New. #10720, eff 11-22-14; ss by #12671, eff
11-7-18
Ph 807.02 Registered Pharmacy Technician Duties. A registered pharmacy technician’s duties,
upon showing the requisite skill and receiving the appropriate training, shall
be:
(a)
Non-discretionary functions within the pharmacy concerning cashier,
stocking, delivery, and other non-clinical functions necessary for pharmacy
operation under the supervision of a licensed pharmacist or certified pharmacy
technician. For purposes of this rule,
performing data entry of a prescription or medication order into the computer
is considered a function reserved for certified pharmacy technicians, as
described in Ph 812.02(a)(6), or registered pharmacy technicians in training to
become certified technicians pursuant to (d) below;
(b)
The counting, weighing, measuring, pouring, and reconstitution of
non-parenteral prescription medication or stock legend drugs and controlled
substances;
(c)
Performing stocking or replenishment of automated dispensing machine,
other automated dispensing equipment or other stock locations. Products shall be verified by a pharmacist or
certified pharmacy technician.
Bar-coding, radio frequency identification, or another form of
electronic verification shall be used at the time of stocking or replenishment,
or a licensed health professional shall check the medication before
administration; and
(d)
If in training to become a certified technician, the duties of a
certified pharmacy technician under the direct supervision of a pharmacist or
certified pharmacy technician.
Source. #10720, eff
11-22-14; ss by #12671, eff 11-17-18; ss by #12951, eff 12-21-19
PART Ph 808 REQUIREMENTS FOR CERTIFIED PHARMACY
TECHNICIANS
Ph 808.01 Certified Pharmacy Technician
Qualifications.
(a)
An applicant for a certified pharmacy technician shall:
(1) Be at least 18 years of age;
(2) Have a high school or equivalent diploma;
(3) Obtain and maintain national certification from a nationally
recognized certifying organization, such as the Pharmacy Technician
Certification Board (PTCB) or the National Healthcare Association (NHA);
(4) Not have been convicted of a drug or
pharmacy-related felony or misdemeanor or admitted to sufficient facts to
warrant such a finding; and
(5) Seek certification from the board within 15
days of the start date of employment as a certified pharmacy technician, and
post such certification in the pharmacy within 30 days.
(b)
A registered pharmacy technician seeking certified status shall obtain
and maintain certification from a nationally recognized certifying
organization, such as the PTCB or the NHA, within one year of entering into a
certified pharmacy program.
(c)
A certified pharmacy technician with duties involving sterile and
non-sterile compounding, shall complete a American Society of Hospital
Pharmacies (ASHP), PTCB, or other nationally recognized training program before
participating in those duties.
(d)
Pharmacy technician applicants with previous out of state experience
shall meet the requirements set by the board in this section before obtaining
certification status.
(e)
No person shall perform
the functions or duties of a certified pharmacy technician unless such person
is certified by the board.
Source. #12671, eff 11-17-18
Ph 808.02 Application Procedures
for Certified Pharmacy Technicians.
(a) Pharmacy technician applicants shall complete
and submit an application form “Initial Application for Pharmacy Technician
Registration” form PT-1, or electronic equivalent, for certification by the
board that contains the following:
(1) Legal name, residence address, mailing
address, home telephone number, personal e-mail address, and social security
number of the applicant;
(2) Date and place of birth, and gender of the
applicant;
(3) Name of current employer and the mailing
address, and phone number of employment site;
(4) Name of supervisor and pharmacy phone number;
(5) An indication as to whether or not the
applicant has been convicted of a drug or pharmacy-related felony or admitted
to sufficient facts to warrant such a finding, and if yes, an explanation of
the circumstances surrounding such a finding or conviction;
(6) An indication as to whether the application
has any other felony convictions and, if so, an explanation of such
convictions; and
(7) Applicant's signature and date.
(b)
The prescribed fee shall be $100, and shall be submitted with the
completed application form.
(c)
“The Initial Application for Pharmacy Technician Registration” form for
pharmacy technicians in New Hampshire may be obtained from and shall be filed at the office of the
board, identified in Ph 103.03.
Source. #12671, eff 11-17-18
PART Ph 809 CERTIFIED PHARMACY TECHNICIAN RENEWALS
Ph 809.01 Renewal Requirements for Certified
Pharmacy Technicians.
(a)
All certified pharmacy technician certifications shall expire biennially
on March 31.
(b)
Applications for the renewal of a certification for a pharmacy
technician may be obtained from, and shall be filed at the office of the board,
identified in Ph 103.03.
(c) A pharmacy technician
applying for renewal shall do so online at https://nhlicenses.nh.gov/eGov/Login.aspx
by providing the following information about him or herself:
(1) Legal name, residence address, mailing
address, personal e-mail address, and a mobile or home telephone number;
(2) License number and work email address of the
pharmacist-in-charge;
(3) Name and phone number of current employer and
address of employment site;
(4) Record of convictions of violations of
federal, state or local drug or pharmacy related laws or regulations;
(5) Report or
copies of continuing education;
(6) Certification
status; and
(7) Applicant’s
signature and date.
(d) The application and the prescribed fee of
$100 shall be filed with the board no later than March 15.
Source. #12671, eff 11-17-18
PART Ph 810 ONGOING REQUIREMENTS FOR CERTIFIED PHARMACY
TECHNICIANS
Ph 810.01 Changes in
Certification Information for Certified Pharmacy Technicians.
(a)
The person to whom a pharmacy technician certification has been issued
shall, within 15 days of a change of address
or location of employment, notify the board of such changes.
(b)
The notice shall contain:
(1) Legal name of certified pharmacy technician;
(2) Address, phone
number, and personal email address of the certified pharmacy technician,
including old and new, if applicable;
(3) Certified pharmacy technician’s New Hampshire
permit number;
(4) Name of the pharmacy where employed including
former and current, if applicable;
(5) Certification status; and
(6) All new violations of law,
convictions, fines, disciplines or any registration, certification, or license
revocations for violation of pharmacy-related drug laws or regulations in this
or any other state.
(c)
Failure to comply with Ph 810.01 shall constitute misconduct under RSA
318.
Source. #12671, eff 11-17-18
Ph 810.02 Continuing Education Requirements for
Certified Pharmacy Technicians.
(a)
Certified pharmacy technicians shall maintain their nationally certified
status and stay up to date with all continuing education requirements such
certification demands.
(b)
A certified pharmacy technician shall retain all certificates and/or
other documented evidence of participation in an approved/accredited continuing
education program/course for a period of 3 years. Such documentation shall be made available to
the board for random audit or verification.
(c)
Certified pharmacy technicians with duties involving sterile and
non-sterile compounding shall complete a minimum of 0.4 CEU’s in the area of
compounding.
(d)
Not less than 10% of certified pharmacy technicians shall be randomly
selected each year by the board for determinations of compliance.
Source. #12671, eff 11-17-18
(formerly Ph 806.04)
Ph 810.03 Excess Continuing Education Requirements
for Certified Pharmacy Technicians.
Excess continuing education units earned in one licensure period shall
not be carried forward into the new licensure period for the purpose of fulfilling
that year’s continuing education prerequisite for licensure renewal.
Source. #12671, eff 11-17-18
Ph 810.04 Penalty. Any certified pharmacy technician who alters,
forges, or intentionally falsifies, or causes to be altered, forged or
falsified, any information, documents, or records required to be kept or
submitted by this rule shall be subject to disciplinary action under RSA
318:29, II.
Source. #12671, eff 11-17-18
(formerly Ph 806.05)
PART Ph 811 REVOCATION, DENIAL, AND REINSTATEMENT OF
CERTIFIED PHARMACY TECHNICIANS
Ph 811.01 Effect of Revocation and Denial for a
Certified Pharmacy Technician.
(a)
The board shall refuse to issue a certification or, after notice and
hearing, shall revoke a certification whenever the board finds, by the
preponderance of the evidence, any of the following:
(1) That the applicant, or certified pharmacy
technician, has violated any of the provisions of RSA 318, RSA 318-B, or the
board’s administrative rules;
(2) That the applicant has been convicted of a
felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule or regulation;
(3) That the applicant has attempted to obtain
certified pharmacy technician status by fraudulent means;
(4) That the applicant is unable to engage in the
performance of certified pharmacy technician functions with reasonable skill
and safety by reason of illness, inebriation, misuse of drugs, narcotics,
alcohol, chemicals or any other substance, or as a result of any mental or
physical condition;
(5) That another state has suspended, revoked, or
placed on probation the applicant’s license, permit, certification, or
registration to practice as a pharmacy technician;
(6) That the applicant refused to appear before
the board after having been ordered to do so in writing; or
(7) That the applicant made any fraudulent or
untrue statement to the board.
(b)
The pharmacist-in-charge shall notify the board, in writing, within one
calendar day after becoming aware that a pharmacy technician has adulterated, abused, stolen or diverted
drugs.
(c)
The board shall issue a new certification after review, provided that
the reason for revocation no longer exists or it is determined that there is no
longer a threat to public safety.
Source. #12671, eff 11-17-18
Ph 811.02 Reinstatement of a Pharmacy Technician
Certification. Certified pharmacy
technicians who either voluntarily or accidentally allow their certification to
lapse as of March 31 of the renewal year shall complete the following
procedures to reinstate their certification:
(a) Complete a
reinstatement application found on the board’s website at https://www.oplc.nh.gov/pharmacy/documents/technician-reinstatement.pdf (revised April 2018);
(b)
Submit the completed application and the prescribed fee to the board’s
office;
(c)
Submit any required documentation as outlined on the form;
(d)
Submit a signed and dated statement as to why the applicant did not
renew his or her pharmacy technician certification prior to expiration and
whether or not the applicant has practiced as a pharmacy technician since his
or her certification has lapsed.
(e)
Submit a current national certification certificate; and
(f)
Submit proof of continuing education as defined in Ph 805.02 completed
within the immediately preceding 24 months.
Source. #12671, eff 11-17-18
PART Ph 812 CERTIFIED PHARMACY TECHNICIANS – STANDARDS OF
PRACTICE
Ph 812.01 Determination of a Certified Pharmacy
Technician’s Duties.
(a)
Any certified pharmacy technician who does not maintain national
certification shall notify the board and the pharmacist–in-charge immediately
of the lapse of certification. Those
whose certification has lapsed shall be permitted to perform the duties of a
registered pharmacy technician, but shall no longer perform the additional
duties of a certified pharmacy technician.
(b)
A certified pharmacy technician shall only perform such tasks and duties
which are prescribed by the permit holder or pharmacist-in-charge based upon
the needs of the pharmacy.
(c)
A certified pharmacy technician’s duties may be further limited by the
pharmacist on duty or the supervising pharmacist.
(d)
Any training given under the direction of a pharmacist shall be
documented by the pharmacist-in-charge and be retrievable upon inspection.
Source. #12671, eff 11-17-18
Ph 812.02 Certified Pharmacy Technicians Duties.
(a)
A certified pharmacy technician’s duties shall include:
(1) Any duties performed by registered pharmacy
technicians under Ph 807.02;
(2) Accepting a new oral telephone order;
(3) Accepting an oral refill authorization;
(4) Communicating a prescription transfer for a
non-control medication to or from another pharmacy that does not maintain a
common database;
(5) Communicating
orally or in writing, any medical, therapeutic, clinical, or drug information,
or any information recorded on a patient profile that does not require
professional judgment;
(6) Performing the data entry
of a prescription or medication order into the computer;
(7) The task of reducing to
writing a prescription left on a recording or message line;
(8) Preparing or compounding
sterile and non-sterile compounds;
(9) Verifying stock replenishment
medications against the stocking/replenishment system, report or label prior to
the stocking/replenishment of the automated dispensing machine, other automated
dispensing equipment, or other stock location provided that bar-coding, radio
frequency identification or another form of electronic verification is used at
the time of stocking/replenishment, or a licensed health professional checks
the medication before administration to the patient;
(10) Clarification of an original
prescription or drug order with a practitioner or authorized agent of the
practitioner; and
(11) Preparation, verification,
and sealing of an emergency kit.
Source. #12671, eff 11-17-18
(formerly Ph 807.03); ss by #12951, eff 12-21-19
CHAPTER Ph 900 MAIL-ORDER/NON-RESIDENT PHARMACY
Statutory
Authority: RSA 318:37, II
PART Ph 901 PURPOSE AND SCOPE
Ph 901.01 Scope.
The provisions of this chapter shall apply to, and impose duties upon,
all mail-order pharmacies holding registrations issued by the board.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 902 DEFINITIONS
Ph 902.01 “Telepharmacy services” refers to the
practice of pharmacy using telecommunications technology to oversee pharmacy
operations and patient care.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 902.02 “Mail-order pharmacy” means “mail-order pharmacy” as defined in RSA
318:1, VII-b, namely, “a pharmacy that is located in a state of the United
States, other than this state, whose primary business is to dispense a
prescription drug or device under a prescription drug order and to deliver the
drug or device to a patient, including a patient in this state, by the United
States mail, a common carrier, or a delivery service. Mail-order pharmacies include, but are not
limited to, pharmacies that do business via the Internet or other electronic
media.”
Source. #13244, eff 7-30-21
(formerly Ph 902.01)
PART Ph 903 REGISTRATION
Ph 903.01 Application.
(a)
No person shall conduct or operate a mail-order pharmacy located outside
of this state by delivering in any manner prescription drugs or prescription
devices into this state unless such pharmacy is registered in New Hampshire and
a permit has been issued by the board.
(b) Application form MO-1,
“Non-Resident/Mail-Order Pharmacy Application for Permit” may be obtained from
and shall be filed at the office of the board, identified in Ph 103.03.
(c) Applicants for
registration as a mail-order pharmacy shall complete and submit form MO-1 or
its electronic equivalent that contains the following information:
(1) Name, address, telephone number, email
address, and Internet address, if applicable, of the pharmacy;
(2) The names, addresses and titles of all
principal corporate officers, if incorporated and if unincorporated, partners
or owners of the pharmacy;
(3) Name, email address, and phone number of the
person responsible for the processing of the application and any subsequent
renewal applications;
(4) Name, email address, and phone number of the
person who is responsible for the actions of the permit;
(5) If a corporation, a certificate of
incorporation from the state in which incorporated;
(6) If a limited liability company, partnership,
or sole proprietorship, a tax ID number or FEIN number;
(7) The name, phone number, email address, and
home-state pharmacist license number of the pharmacist-in-charge of the
location listed in (1) above;
(8) A copy of the pharmacy’s home state permit;
(9) A copy of the most recent inspection report
conducted by the state in which the pharmacy is located within the past 18
months;
(10) An un-redacted copy of the most recent United
States Food and Drug Administration inspection and 483 observation(s);
(11) A copy of the un-redacted inspection and
observation response, if applicable;
(12) If the pharmacy is exempt from registering
with the PDMP, complete the following attestation:
“I attest, that
the above-named pharmacy, for which I am the Pharmacist In Charge, is exempt
from registering and reporting to the New Hampshire Prescription Drug
Monitoring Program per NH RSA 318-B:33:
□ The
Pharmacy does not have a Drug Enforcement Administration (DEA) Registration at
all and does not do any business (dispensing, distributing, and/or shipping)
related to any Federally Scheduled Controlled Substances in either the
pharmacy’s home-state or any other U.S. State; or
□ The
pharmacy only has a Drug Enforcement Administration (DEA) registration for
schedule V Controlled Substances and does not do any business with Schedule
II-IV Controlled Substances (dispensing, distributing, and/or shipping) in
either the pharmacy’s home-state or any other U.S. state – if selecting this
box, you Must attach a copy of the pharmacy’s current DEA registration.
By signing below I
understand and affirm, that should the above-named pharmacy obtain a DEA registration
for schedule II-IV and/or aspire to begin distributing/dispensing controlled
substances in these schedules (either in its home-state or any other state),
that I, and this pharmacy, will immediately notify the New Hampshire Board of
Pharmacy and properly submit the required application as defined in Ph 904, and
register with the NH Prescription Drug Monitoring Program as required by NH RSA
318-B:33”; and
(13) The signature of the pharmacist-in-charge and
date below the following attestation:
“I attest that I
have read the NH Laws; RSA 318 and RSA 318-B and Administrative Rules for the
profession that I have applied for on this renewal. I attest to reading Ph
904.01; which states in part, 'the Board must be notified within 30 days of any
changes to any information from the original application'. I attest that I have
answered all questions truthfully, accurately and I hereby attest that if any
information on this application was submitted falsely or is misleading or a
misrepresentation of the facts, I understand that such an act shall constitute
cause for potential denial, revocation, or disciplinary actions of the
registration that I am applying for. I understand that the pharmacy permit is
issued in the name of the corporation or owner of the pharmacy and that a duly
designated pharmacist in charge, as designated on this application, has
accepted responsibility for the safe, effective operation of the pharmacy. My
signature; ink or electronic; constitutes my acknowledgement of the
responsibilities of both the pharmacist in charge and the
corporation/owner/permit holder regarding the safe operation of the pharmacy.”
(d)
Documents required for an initial application shall include:
(1) A copy of the home state permit;
(2) A copy of a prescription label, containing
the name, address, and phone number of the pharmacy, that would be used on
finished prescription products mailed to NH residents;
(3) A copy of the
inspection report of the facility, created in the last 18 months, from one of
the entities listed in Ph 906.03(d)(1);
(4) A list of all the corporate officers, owners,
title, and organization chart;
(5) A sample copy of a printed patient medication
profile that shall include the following information:
a. Name and address of the patient;
b. Name, address and DEA registration number of
the prescriber;
c. Name, strength, and quantity of drug
dispensed;
d. Assigned prescription number;
e. Date of original filling; and
f. Date of refill(s);
(6) Pictures of the following locations at the
facility:
a. Outside entrance and signage;
b. The office setting;
c. The area of the facility where the
refrigeration for medications is located;
d. The storage room for all medications,
including the actual container storing the medication; and
e. The hot-and-cold water setup for the
medications;
(7) A copy of the certificate of the alarm system
is in place, or other proof the facility is alarmed;
(8) Scaled drawing of the facility and drug
storage area;
(9) Copies of the following documents:
a. A copy of an inspection report, created
within the last 18 months, which documents compliance with the board rules
regarding sterile and non-sterile compounding in compliance with the United
States Pharmacopeia Chapter 797 and Chapter 795 pursuant to RSA 318:14-a
performed by:
1. Your home state’s board of pharmacy;
2. The National Association of Boards of
Pharmacy (NABP); or
3. New Hampshire board of pharmacy approved
third party entity;
b. The below attestation, signed by the
pharmacist-in-charge:
“
Sterile Compounded Drugs (Patient-Specific Only) * If shipping Sterile Compounded
Products to NH Residents, you must attach items 1-5; additionally, by signing
this application you acknowledge that the pharmacy has item #6 on hand and
available upon request:
1. Any and all GAP
analysis reports related to the pharmacy done within the last twelve (12)
months;
2. Any and all
certification documents on compounding equipment done within the last six (6)
months;
3. An inventory
listing of any / all products shipped into the State of New Hampshire within
the last six (6) months, including product, quantity, location of shipment, and
date of shipment;
4. Any Department
of Health and Human Services, Food and Drug Administration Inspection Reports
(Form FDA 483) issued within the last twelve (12) months and any responses
submitted to these agencies by the pharmacy;
5. Any state
inspection reports issued within the last eighteen (18) months and any
responses submitted to these agencies regarding the inspection reports by the
pharmacy; and
6. The pharmacy’s
policies and procedures on sterile compounding. (Do not attach – but must be
available upon request);”
c. A hood certification inspection report
completed under dynamic conditions, not at rest, within the last 6 months;
d. A current environmental monitoring report,
dated within the last 6 months, which includes:
1. Viable air and
surface sampling; and
2. HEPA filter performance testing;
e. If the facility does not have a clean report,
submit the following as well:
1. CAPA Report;
2. Identify the issue and explain in writing to
the board;
3. A detailed report of what the corrective
action plan is; and
4. A statement explaining if this is detailed in
the facility’s SOPs or P&P Manual; and
(10) The fee as specified in Plc 1000.
(e)
Failure to comply with any of the provisions of Ph 903 shall result in
denial of a permit.
(f) Initial applications shall remain open and active for 60
days upon receipt of a completed application. An application is considered
completed when all documentation required by the rules, application, any other
supporting documentation to show proof the company is compliant with board
rules, and the fee, are received by the board.
If the application and all supporting documentation are not completed by
the applicant within 60 days, the application will turn to an inactive status
and the applicant will have to begin the process from the beginning.
(g)
Any person or pharmacy whose pharmacy business model fits the definition
of a mail-order pharmacy and delivers prescription
drugs or prescription devices to New Hampshire residents from more than one
out-of-state pharmacy shall register each such pharmacy separately.
(h) Pharmacists providing “telepharmacy services”
to New Hampshire residents shall be licensed with the board unless performing
these actions on behalf of a pharmacy licensed or otherwise registered by the
board.
Source. #7474, eff 4-5-01;
amd by #9139-B, eff 4-25-08; ss by #9341, eff 12-4-08; ss by #10663, eff
9-3-14; ss by #13244, eff 7-30-21
PART Ph 904 REGISTRATIONS – CHANGES IN SUPPORTING DATA
Ph 904.01 Reporting Changes.
(a)
The mail-order pharmacy to which a registration has been issued shall
within 30-days of any change of information supplied in the original
application, notify the board.
(b)
The notice required pursuant to (a) above shall contain:
(1) Current New Hampshire registration number;
(2) Name of the pharmacy, old and new;
(3) Address of the pharmacy;
(4) Name of the pharmacist-in-charge;
(5) The effective date of the change; and
(6) The reason for
the change.
(c)
A new application shall be required for a change of ownership of an
established pharmacy to a successor business
entity which results in a change in the controlling interest in the pharmacy
and include:
(1) A change from the parent level down shall
require a new application to be submitted within 30 days after the effective
date of the change; and
(2) A change from the
grandparent level up submit a letter on company letterhead, dated and signed,
including the information as outlined in Ph 904.01 (b) above. The letter shall be submitted by attaching to
an email to pharmacy.licensing@oplc.nh.gov with the NH registration number in
the subject line.
(d)
If a new license is issued as a result of (c) above a new license number
shall be issued.
(e)
If a company is already established in New Hampshire as a permit holder
and would like to change its business practice model to include
dispensing/shipping controls into New Hampshire, the company shall submit the
following:
(1) Initial application
that notes your current NH license number, along with all supporting
documentation as required by Ph 903, excluding the fee; and
(2) This
application to add on the dispensing/shipping controls into New Hampshire,
shall be submitted 60 days prior to the anticipated beginning of
shipping/dispensing date.
(e) The pharmacy shall receive an
updated permit, from the board that shows they have been authorized by the
board, before beginning to dispense/ship into NH.
(f)
Any failure to notify the board of any of the changes listed in Ph 904
or the original application as submitted to the board shall result in the
commencement of disciplinary proceedings if there is evidence that the failure
to notify the board:
(1) Was knowingly or negligently made; and
(2) Is a violation of RSA 318:29, II, other
applicable laws, or rules adopted by the office of professional licensure and
certification, or the board.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 905 REVOCATION AND DENIAL
Ph 905.01 Effect of Revocation
and Denial.
(a)
The board shall refuse to issue a registration or shall revoke a registration whenever the board
determines that a mail-order pharmacy, its pharmacist-in-charge, owner(s), or
corporate officer(s) has, after notice and opportunity for a hearing, except
pursuant to (c) below, committed misconduct such as but not limited to:
(1) Made a materially false representation or
withheld material information in connection with obtaining its registration;
(2) Been found guilty of any felony in connection
with the practice of pharmacy or distribution of drugs within the past 5 years;
(3) Made false representations in connection with
the practice of pharmacy that endanger or are likely to endanger the health or
safety of the public, or that defraud any person;
(4) Failed to comply with RSA 318:37, II, the
provisions of Ph 900, or both;
(5) Based on an investigation of a complaint
resulting from the dispensing of prescription drugs or prescription devices to
a resident of New Hampshire been found to be negligent:
a. By the board of pharmacy of the state in
which the pharmacy is located; or
b. By the board if the board of pharmacy of the
state where the pharmacy is located failed to initiate an investigation of such
complaint within 45-days after referral of the complaint from the board; or
(6) Been found guilty of any violation of
federal, state, or local drug law or have entered into any agreement to resolve
violations of such.
(b)
A mail-order pharmacy shall notify the board within 15 days of any initial
disciplinary action by a board of pharmacy, or any other state or federal
agency, imposing disciplinary action on the pharmacy.
(c) Notwithstanding the provisions of (a) above, if the license, permit
or registration in the state where the pharmacy is located, is suspended or
revoked, then the pharmacy’s registration in New Hampshire shall, after notice
and opportunity for hearing, be suspended or revoked for the same period of
time.
(d)
Notwithstanding the above, the board shall issue a registration or not
revoke if:
(1) No harm resulted from the actions of the
applicant or registrant;
(2) There was no intent to violate any provisions
of RSA 318;
(3) Corrective action has been taken by the
registrant;
(4) Remunerations have been made to the affected
party(s); and
(5) The board determines the action is unlikely
to occur again.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 906 RENEWAL OF REGISTRATIONS
Ph 906.01 Renewal Registrations Required. All mail-order pharmacy registrations shall
expire on December 31 biennially in each odd-numbered
year for odd-numbered licenses or on December 31 of each even-numbered year for
even-numbered licenses.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 906.02 Renewal Application
Where Obtained and Filed.
Applications for the renewal of a registration for a mail-order pharmacy
may be obtained from, and shall be filed at, the office of the board, identified
in Ph 103.03 or online.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 906.03 Renewal Application Contents and When
Filed. Renewal applications shall be
filed with the board in accordance with the following:
(a) Applications for renewal of a registration
for a mail-order pharmacy shall be made by using the on-line form “License/Permit/Registration
Renewal”, revised edition 9/2014, located on the office of professional
licensure and certification web site, https://forms.nh.gov/license/Login.aspx;
(b)
Documents to be submitted for
renewal shall be received by the office no later than November 30th for the
anticipated expiration date of December 30th.
(c) An applicant who
does not practice sterile or non-sterile compounding shall submit the
following:
(1) A copy of the pharmacy’s home state permit;
(2) A copy of the pharmacy’s controlled
substances permit if issued by the pharmacy’s home state;
(3) A copy of the DEA certificate;
(4) A copy of the pharmacy’s full, un-redacted
inspection report created within the last 24 months, showing compliance with
board rules, or a certificate of accreditation;
(5) A copy of any responses to
any violations or discipline and your company’s plan of action to bring your
facility into compliance. Such responses
shall be signed and dated by the person that is responsible for the actions of
the permit or pharmacist in charge; and
(6) The application and the fee as specified in
Plc 1000;
(d) An applicant who practices sterile and non-sterile compounding shall submit the
following to renew the pharmacy permit biennially:
(1) A copy of an inspection report, created
within the last 18 months, which documents compliance with the board rules regarding sterile
and non-sterile compounding in compliance with the United States Pharmacopoeia
Chapter 797 and Chapter 795 pursuant to RSA 318:14-a, I performed by:
a. The pharmacy’s home state’s board of
pharmacy;
b. The NABP; or
c. Board approved third party entity;
(2) A copy of the home state board of pharmacy
permit;
(3) The below attestation, signed and dated by
the pharmacist in charge:
“
Sterile Compounded Drugs (Patient-Specific Only) * If shipping Sterile
Compounded Products to NH Residents, you must attach items 1-5; additionally,
by signing this application you acknowledge that the pharmacy has item #6 on
hand and available upon request:
1. Any and all GAP analysis reports related to
the pharmacy done within the last twelve (12) months;
2. Any and all certification documents on
compounding equipment done within the last six (6) months;
3. An inventory listing of any / all products
shipped into the State of New Hampshire within the last six (6) months,
including product, quantity, location of shipment, and date of shipment;
4. Any Department of Health and Human Services,
Food and Drug Administration Inspection Reports (Form FDA 483) issued within
the last twelve (12) months and any responses submitted to these agencies by
the pharmacy;
5. Any state inspection reports issued within
the last eighteen (18) months and any responses submitted to these agencies
regarding the inspection reports by the pharmacy; and
6. The pharmacy’s policies and procedures on
sterile compounding. (Do not attach – but must be available upon request);”
(4) A hood certification inspection report
completed under dynamic conditions, not at rest, within the last 6 months;
(5) A Copy of the DEA permit;
(6) An environmental monitoring report, dated
within the last 6 months, that includes:
a. Viable air and surface sampling; and
b. HEPA filter performance testing;
(7) If the facility does not have a clean report,
the applicant shall submit the following as well:
a. CAPA report;
b. Identify the issue and explain in writing to
the board;
c. Explain what the corrective action plan is;
and
d. An indication whether this is in the SOP’s
and P & P Manual; and
(8)
Inventory list of last 6 months of sterile compounded products shipped into NH
including:
a. Product name;
b. Quantity;
c. Location of shipment; and
d. Date of shipment.
Source. #7474, eff 4-5-01;
amd by 9139-B, eff 4-25-08; ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14;
ss by #13244, eff 7-30-21
Ph 906.04 Failure to Comply. Failure to comply with any of the provisions
of Ph 906 shall result in non-renewal of the pharmacy permit.
Source. #10663, eff 9-3-14;
ss by #13244, eff 7-30-21
PART Ph 907 CONDITIONS OF REGISTRATION
Ph 907.01 Compliance. As conditions of registration, the mail-order
pharmacy shall:
(a)
Maintain at all times a valid unexpired permit, license, or registration
to conduct the pharmacy in compliance with the laws of the state in which it is
a resident;
(b)
Maintain in readily retrievable form, records of legend drugs, devices,
or both dispensed to New Hampshire patients;
(c)
Supply upon request, all information needed by the board to carry out
its responsibilities under the statutes
and rules pertaining to mail-order pharmacies;
(d)
Provide for a toll-free telephone or other virtual means of
communication for consultation between New Hampshire patients and a pharmacist at the mail-order pharmacy
who has access to the patient’s records, and ensure that such toll-free
telephone number(s) shall be placed upon the label affixed to each prescription
container;
(e)
Provide to the board,
upon request, a copy of the policies and procedures governing:
(1) Normal delivery protocols and times;
(2) Any special packaging or procedures used in
delivering temperature-sensitive drug products;
(3) The procedure to be followed if the patient’s
medication is not available at the mail-order pharmacy, or if delivery will be
delayed beyond the normal delivery time;
(4) The procedure to be followed upon receipt of
a prescription for an acute illness, which shall include a procedure for delivery
of the medication to the patient from the mail-order pharmacy at the earliest
possible time, such as courier delivery, or an alternative that assures the
patient the opportunity to obtain the medication at the earliest possible time;
and
(5) The procedure to be followed when the
mail-order pharmacy is advised that the patient’s medication has not been
received within the normal delivery time and that the patient is out of
medication and requires interim dosage until mail prescription drugs become available;
(f)
All finished prescription products shipped to New Hampshire residents
shall be shipped in tamper-evident envelopes
or boxes;
(g)
A mail-order pharmacy shall not dispense or sell to the public any drug
which is adulterated or misbranded;
(h)
A mail-order pharmacy shall supply, upon request from the board, a
statement of origin of any specific drug dispensed to a New Hampshire resident;
and
(i) Any mail-order pharmacy shipping finished prescription
products into the State of New Hampshire shall use the address, but without the
name of the pharmacy, on file with the New Hampshire board of pharmacy as the return address on the labels of
any package shipped into the State of New Hampshire. The return address shall be placed on the
package in a clear and prominent manner.
Source. #7474, eff 4-5-01;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
CHAPTER
Ph 1000 STANDARDS OF PRACTICE FOR
MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS
PART Ph 1001
LICENSING
Ph
1001.01 License Required.
(a) No person shall manufacture or act as a
wholesale distributor of prescription drugs or prescription devices without
first obtaining a license to do so from the board pursuant to this
chapter. No license shall be issued or
renewed for a manufacturer or wholesale drug distributor unless the same shall
be operated in a manner prescribed by law and according to the rules adopted by
the board with respect thereto.
(b) Separate licenses shall be required for each
manufacturing and distribution site owned or operated by a manufacturer or
wholesale distributor. Provided however,
that an agent or employee of any licensed manufacturer or wholesale distributor
shall not be required to be licensed under this section and may lawfully
possess prescription drugs and devices if the agency or employee is acting in
the usual course of his or her business or employment.
(c) All licenses for manufacturers and wholesale
distributors of prescription drugs and medical devices containing a
prescription drug shall expire biennially on June 30th of every
even-numbered year. The renewal
application may be obtained from the board office. Alternatively, applicants may file the
renewal application online at https://nhlicenses.nh.gov/eGov/Login.aspx.
(d) The prescribed fee for original and biennial
renewal licenses for manufacturers and wholesale distributors of prescription
drugs and devices shall be $500.
(e) No in-state license shall be issued until
such time as the applicant has satisfactorily completed a site inspection
performed by the board confirming the facility:
(1) Is of
suitable size, construction, and location to allow proper storage, handling and
security of drugs;
(2) Is located
in a commercially zoned area;
(3) Has
adequate outside lighting to allow for proper security;
(4) Has
notified the local police department that legend drugs are being stored at the
facility; and
(5) Has a
functioning alarm system in place.
Source. #8447, INTERIM, eff
10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.01); ss
by #13117, eff 10-15-20
Ph
1001.02 Obtaining and Filing a License
Application. Applications for licensure of manufacturers, wholesalers and
distributors may be obtained from, and shall be filed at, the board office,
identified in Ph 1003.03.
Source. #8447, INTERIM, eff
10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.02)
Ph
1001.03 Application Contents.
(a) The applicant for licensure shall complete and
submit the board provided form Ph A-5, revised 09/16.
(b) Applicants shall also submit 2 photographs of
the existing exterior of the facility in which the applicant is located. These photographs shall include any outside
signage. Artist sketches or architect
plans or drawings shall not be acceptable.
(c) Applicants shall also submit at least 4
photographs of the interior of the facility showing legend drug storage areas,
refrigeration units and any specially constructed areas for storage of controlled
substances.
(d) In-state applicants shall also submit a
scaled floor plan of the proposed facility.
(e) Applicants shall supply a list of all states
where licensed and include license number.
Source. #8447, INTERIM, eff
10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.03)
PART Ph 1002
OPERATIONS
Ph
1002.01 Storage Conditions.
(a) All facilities at which prescription drugs
are repackaged, wholesaled, stored, held, sold, offered for sale, exposed for
sale, or kept for sale shall provide storage areas that have:
(1) Adequate
lighting;
(2) Adequate
ventilation;
(3) Proper
sanitation;
(4) All drugs
or chemicals shall be stored at appropriate temperatures and humidity per label
requirements;
(5)
Refrigerator temperatures are monitored on a daily basis; and
(6) Room temperature
is maintained and monitored on a daily basis.
(b) A separate storage section shall be provided
for prescription drugs that are deteriorated, outdated, misbranded, or
otherwise adulterated.
Source. #12007, eff 10-22-16
(formerly Ph 309.04)
Ph
1002.02 Facilities.
(a) All buildings in which prescription drugs are
wholesaled, repackaged, stored, held, sold, offered for sale, exposed for sale,
or kept for sale shall be of suitable size, construction, and location to meet
the requirements set forth in this chapter.
(b) Buildings shall meet all applicable federal,
state, and local standards. A facility
shall not be located in a residence. All
facilities shall be located in an area that is commercially zoned.
(c) A wholesale drug distribution facility shall
notify the local police department or other appropriate law enforcement agency
that it is a distributor of prescription drug products and controlled
substances.
Source. #12007, eff 10-22-16
(formerly Ph 309.05)
Ph
1002.03 Security.
(a) Each wholesale drug distribution center shall
be equipped with an internal alarm system to detect entry after hours. The alarm system shall be of the type that
transmits a signal directly to a central station protection company, to a local
or state police agency that has a legal duty to respond, or a 24 hour control
station operated by the wholesale drug distributor.
(b) Manufacturers and wholesale drug distributors
shall ensure that all access from outside their premises is secure. This shall include, but not be limited to,
the installation of adequate lighting at the outside perimeter of the premises.
(c) Internal security policies shall be developed
to provide protection against theft by personnel.
Source. #12007, eff 10-22-16
(formerly Ph 309.06)
Ph
1002.04 Recordkeeping.
(a) Inventories and other records of transactions
regarding the receipt and disposition of prescription drugs shall be maintained
and made available for inspection by the board's inspectors for a period of 2
years.
(b) Records may be kept at a central location
rather than at each distribution center, but records shall be made available
for inspection within 72 hours of request by the board's inspectors.
Source. #12007, eff 10-22-16
(formerly Ph 309.07)
Ph 1002.05 Inspections.
(a) Inspections shall be performed by the board's
inspectors and be conducted at the request of the board.
(b) Inspections shall be conducted during normal
business hours.
(c) Information that is considered to contain
trade secrets or which might be proprietary in nature shall be protected from
public disclosure.
Source. #12007, eff 10-22-16
(formerly Ph 309.08)
Ph
1002.06 Written Policies and
Procedures.
(a) Written policies and procedures shall be
developed by management personnel to assure that the manufacturer and wholesale
drug distributor prepares for, protects against, and handles crisis situations
that affect the security or operation of the facility. Such crises shall include fires, floods, or
other natural disasters, and situations of local, state or national emergency.
(b) Written policies and procedures described in
(a) above shall also provide for:
(1) The
management and correction of all errors or inaccuracies in inventories;
(2) The
assurance that any outdated stock, or any stock with an expiration date that,
in the wholesale drug distributor's view, does not allow sufficient time for
repacking or resale, shall be prepared for return to the manufacturer or
otherwise destroyed;
(3) The control
over the shipping and receiving of all stock within the operation; and
(4) A process
for storage and disposal of hazardous drugs.
(c) Policies and procedures will be reviewed on a
regular basis.
(d) A copy of the policies and procedures, or
sections thereof, shall be made available to the board upon request.
(e) All manufacturers, wholesalers and distributors
shall notify the board when it initiates a class I recall based on an FDA
inspection.
Source. #12007, eff 10-22-16
(formerly Ph 309.09)
Ph
1002.07 Returned Goods. A wholesale operation shall maintain a
procedure for the proper handling and disposal of returned goods.
Source. #12007, eff 10-22-16
(formerly Ph 309.10)
Ph
1002.08 Handling Recalls.
(a) A wholesale operation shall maintain a
written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover
all recalls and withdrawals of prescription drug products due to:
(1) Any
voluntary action on the part of the manufacturer;
(2) The
direction of the Food and Drug Administration, or any other federal, state or
local governmental agency; and
(3) Replacement
of existing merchandise with an improved product or new package design.
Source. #12007, eff 10-22-16
(formerly Ph 309.11)
Ph
1002.09 Responsibility for Operation. A wholesale drug distribution operation shall
maintain a list of principals and persons in charge including officers,
directors, or primary stockholders and their qualifications.
Source. #12007, eff 10-22-16
(formerly Ph 309.12)
Ph
1002.10 Compliance with State and
Federal Law.
(a) All manufacturers, wholesalers and
distributors shall comply with all applicable state and federal laws,
regulations and rules.
(b) All manufacturers, wholesalers and
distributors, doing business in New Hampshire, shall, before shipping or
distributing any prescription drug, verify that the recipient is properly
licensed to receive and possess such drugs.
(c) All manufacturers, wholesalers and
distributors, licensed and doing business in the state of New Hampshire, shall
not provide unsolicited controlled drug samples to licensed practitioners.
(d) A manufacturer’s license shall allow for the
direct wholesaling or distribution of such drugs to other licensed or
authorized recipients.
(e) A duly authorized agent of a manufacturer,
wholesaler or distributor licensed in this state, may possess and distribute
potent or prescription drugs to individuals who may lawfully possess such drugs
as may be necessary to further the licensed activity of the manufacturer,
wholesaler or distributor.
Source. #12007, eff 10-22-16
(formerly Ph 309.13)
Ph
1002.11 Violations.
(a) No manufacturer or wholesaler shall
distribute prescription drugs directly to a consumer or a patient, or operate
in such a manner as to endanger the public health.
(b) Any person who manufactures, wholesales, or
otherwise distributes prescription drugs, according to RSA 318:51-a and the
provisions of Ph 1000, shall be subject to disciplinary action as provided in
RSA 318:29.
Source. #12007, eff 10-22-16
(formerly Ph 309.14)
Ph 1002.12 Reporting Changes.
(a)
It shall be the responsibility of the manufacturer or wholesaler to
immediately notify the board of any changes of information submitted in the
application for licensure.
(b)
Failure to provide the board with notification of changes in the
application contents, within 30 days of such changes, shall subject the
licensee, after notice and opportunity to be heard pursuant to Ph 200, to a
fine of $150.00.
(c)
The deadline for renewal applications shall be midnight June 30th
of every even-numbered year. Any
application received after that date shall be subject to a $25.00 reinstatement
fee. Licenses shall not be issued until
the late fee is satisfied. Licensees
shipping to or doing business in New Hampshire with an expired license shall be
subject to discipline by the board pursuant to RSA 318:55.
(d)
If the ownership at the customer service level has changed, the name of
the business has changed or more than 50% of the stock ownership has changed
hands then a new application shall be required.
(e)
If a manufacturer, wholesaler, or distributor has any license or permit
revoked, suspended, or voluntarily surrendered, the facility shall notify the
board within 7 days and include a copy of the corresponding documentation.
Source. #12007, eff
10-22-16; ss by #13117, eff 10-15-20
Ph
1002.13 Discontinuance of Business.
(a) Any licensee that intends to cease business
activity shall inform the board, in writing, no less than 30-days prior to the
anticipated closing.
(b) If the records of receipt and disposition are
maintained electronically, a complete record of transactions, for the current 2
year period, shall be reduced to printed form prior to the actual close of
business.
Source. #12007, eff 10-22-16
Ph
1002.14 Disposition of Drugs and
Records.
(a) The balance of any inventory of
non-controlled drugs may be sold to another wholesaler or manufacturer with
invoices available to each party and a copy for the board’s files.
(b) The remaining balance of any controlled drugs
may be transferred or sold to another wholesaler / manufacturer as a package
along with:
(1) A hard copy
record of the receipt and distribution of controlled substances for the past 2
years;
(2) All CII
drugs shall be transferred by DEA Form 222;
(3) All CIII –
V drugs shall be transferred by invoice with copies to the applicable parties
and to the board;
(4) The last 2
completed Biennial Inventory forms;
(5) All unused
DEA 222 forms shall be returned to the DEA, along with the current DEA
registration, marked VOID; and
(6) The current
NH manufacturer – wholesaler license shall be relinquished to the board.
Source. #12007, eff 10-22-16
Ph
1002.15 Distributing Adulterated or
Misbranded Drugs.
(a) A wholesaler or distributor shall not distribute
any drug which is adulterated or misbranded.
After notice and opportunity for a hearing, a wholesaler, distributor
who is found by the board to have knowingly distributed or otherwise sold for
consumption an adulterated or misbranded drug, shall be subject to disciplinary
action according to RSA 318:29.
Source. #12007, eff 10-22-16
CHAPTER Ph 1100
COLLABORATIVE PHARMACY PRACTICE
PART Ph 1101
PURPOSE
Ph
1101.01 Purpose. The purpose of this chapter is to implement
and regulate collaborative pharmacy practice as a means to make the provision
of certain aspects of health care more efficient, less costly, and provided in
a more timely manner.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1102
DEFINITIONS
Ph
1102.01 “Attending practitioner” means
“attending practitioner” as defined in RSA 318:1, XXV, namely, “the physician
or advanced practice registered nurse who has the primary responsibility for
the treatment and care of the patient” and as outlined in the collaborative
agreement.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1102.02 “Collaborative pharmacy
practice” means “collaborative pharmacy practice” as defined in RSA 318:1,
XXVI, namely, “the practice of pharmacy whereby one or more pharmacists jointly
agree, on a voluntary basis, to work in conjunction with one or more attending
practitioners under written protocol whereby the collaborating pharmacist or
pharmacists may perform medication therapy management authorized by the
attending practitioner or practitioners under certain specified conditions and
limitations.”
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1102.03 “Collaborative pharmacy practice
agreement'' means “collaborative pharmacy practice agreement'' as defined in
RSA 318:1, XXVII, namely, “a written and signed specific agreement between a
pharmacist, an attending practitioner, and the patient or patient's authorized
representative who has granted his or her informed consent, that provides for
collaborative pharmacy practice for the purpose of medication therapy
management for the patient.” The term
includes each protocol developed pursuant to RSA 318:16-a, II(a).
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1102.04 “Board” means “board” as defined
in RSAA 318:1, III.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1103
COLLABORATIVE PHARMACIST QUALIFICATIONS AND APPLICATION
Ph
1103.01 Qualifications.
(a) A pharmacist who seeks to engage in
collaborative practice shall:
(1) Hold an unrestricted
and current license to practice as a pharmacist in New Hampshire;
(2) Have at
least $1,000,000.00 of professional liability insurance that covers services
performed under a signed, written collaborative agreement;
(3) Have the
knowledge to properly perform the duties in the collaborative agreement; and
(4) Depending
on the complexity of services to be provided by the pharmacist the board shall
require additional education credits to meet the needs of the collaborative
practice agreement.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1103.02 Attending Practitioner
Qualifications. Pharmacists shall not enter into a collaborative agreement
with any other practitioner unless that practitioner:
(a) Holds an active, unrestricted license to
practice in the state of New Hampshire;
(b) Has prescriptive authority granted by a New
Hampshire licensing board; and
(c) Authorizes the pharmacist to perform only
those services that fall within that practitioner’s scope of practice.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1104
APPLICATION AND SUPPORTING DOCUMENTATION
Ph
1104.01 Application.
(a) A pharmacist who seeks to engage in
collaborative practice shall submit:
(1) A completed
and signed “Collaborative Practice Application”, effective December 2017 and
available on the board’s website;
(2) A certificate of insurance from the pharmacist’s
professional liability carrier indicating that the pharmacist maintains
insurance coverage that complies with RSA 318:16-a, I(b), and covers the duties
and responsibilities within the collaborative agreement; and
(3) A copy of
the collaborative agreement, as well as detailed information on the quality
assurance program required by RSA 318:16-a, IV (c).
(b) A pharmacist who seeks to engage in the
administration of vaccines shall hold current basic or higher certification in
cardiopulmonary resuscitation (CPR) from the American Heart Association, the
American Red Cross, or from another organization or entity that is nationally
recognized as an issuer of such certifications.
(c) After receipt of a “Collaborative Pharmacy
Practice Application” the board’s staff shall review it for any apparent errors
or omissions and inform the applicant in writing if any are found. If informed of errors or omissions, the
pharmacist shall correct the error or provide the missing application materials
within 30 days of such notification being sent.
(d) Pharmacists engaged in collaborative practice
shall provide written or electronic notification to the board of any change to
the original application or supporting documentation within 15 days of such
change taking effect.
Source. #9381, eff 1-31-09,
EXPIRED: 1-31-17
New. #12464, eff 1-23-18 (from Ph 1103.02)
PART Ph 1105
COLLABORATIVE PRACTICE AGREEMENTS AND INFORMED CONSENT
Ph
1105.01 Collaborative Practice
Agreements.
(a) Collaborative practice agreements shall
describe in detail services that a pharmacist may perform for a patient that
provides informed consent, including but not limited to:
(1) Specific
drugs to be managed by the pharmacist;
(2) Terms and conditions under which a drug therapy
may be implemented, modified, or discontinued;
(3) Conditions
and events upon which the pharmacist is required to notify the collaborating
practitioner, and the manner and time frame in which such notification shall
occur;
(4) The
laboratory tests that may be ordered to manage a medication therapy;
(5) Activities
which may be performed by the pharmacist in conjunction with a written
protocol;
(6) A statement
of the expected amount of dedicated time that a pharmacist will use exclusively
to perform duties in the collaborative agreement;
(7)
Documentation of the care delivered and, if applicable, methods of
communication of essential information the patient’s other health care
providers;
(8) Education
and training designed to enhance patient understanding and the appropriate use
of his or her medication;
(9) The
beginning and ending dates of the period of time during which the agreement is
in effect;
(10) A statement that the agreement may be terminated
in writing by either party at any time, subject to (c) below; and
(11) A
description of the private, HIPAA-compliant space to be utilized for
collaborative practice.
(b) Collaborative agreements shall be renewed at
least every 2 years, and signed by all practitioners who are a party to the
agreement.
(c) When a collaborative agreement is terminated,
the patient shall be provided written notification within 15 days. Such written
notification shall include detailed information on how the patient may continue
any medication therapy provided by the pharmacist without interruption.
(d) Collaborative practice agreements shall
include quality metrics developed by pharmacist(s) and physician(s) or nurse
practitioner(s) that shall be reported to the board on an annual basis.
(e)
Collaborative agreements shall include, in a format determined by the parties
to the agreement, written informed consent signed by the patient or the
patient’s authorized representative and containing the information specified in
Ph 1105.02.
(f)
Pharmacists shall keep a copy of each collaborative agreement, including any protocols
specified in such agreements, to which they are a party at their place of
practice.
(g)
Collaborative agreements, protocols, and written informed consents shall be
available for inspection and review by the board or its agents at any time
during the pharmacist’s normal business hours.
Source. #12464, eff 1-23-18
(from Ph 1104.01)
Ph
1105.02 Informed Consent of Patient
or Patient’s Authorized Representative.
(a)
Patient informed consents shall include, but not be limited to, the following
information:
(1) A statement
that the patient or the patient’s authorized representative has read,
understood, and consented to the pharmacist performing the duties outlined in
the agreement;
(2) The full
name and address of the patient;
(3) The full
name and address of the collaborative attending practitioner; and
(4) The full
name and address of the collaborating pharmacist.
Source. #12464, eff 1-23-18
(from Ph 1104.02)
Ph
1105.03 Practice Under a
Collaborative Practice Agreement.
(a) Practice by a pharmacist under a collaborative
practice agreement shall not be delegable and shall be performed only by the
pharmacist who is a party to the agreement.
(b) At least once per year, the pharmacist shall
review the collaborative practice agreement and each protocol developed
pursuant thereto so as to determine whether changes should be made to reflect
the standard of care. If such a review
reveals that a change should be made, the pharmacist shall inform the attending
practitioner and the patient or the patient’s authorized representative.
(c) Nothing in this chapter shall be construed to
prohibit an authorized pharmacist from participating in medication therapy
management by protocol or policy approved by the medical staff of the hospital,
so long as such participation is limited to drugs administered to a patient by
an individual licensed to administer the drug to the patient in an in-patient
or outpatient hospital setting.
(d) Nothing in this chapter shall be construed to
prohibit a pharmacist from performing medication therapy management services
that do not require a collaborative agreement, such as:
(1) Performing
patient assessment or comprehensive medication review;
(2) Formulating
a medication treatment plan;
(3) Monitoring
efficacy and safety of medication therapy;
(4) Enhancing
medication adherence through patient empowerment and education; and
(5) Documenting
and communicating medication therapy management services to prescribers in
order to maintain comprehensive patient care.
(e) In the event the board places a restriction
on a pharmacist license, that pharmacist shall cease working under any
collaborative agreement immediately upon being restricted. Once the restriction
has been removed by the board, the pharmacist may reapply for collaborative
practice.
(f) In the
event a licensing board places a restriction on an attending practitioner, the
pharmacist shall cease working under any collaborative agreement with that
attending practitioner. Once the restriction has been removed by the respective
licensing board, the pharmacist may reapply for collaborative practice with
that attending practitioner.
Source. #12464, eff 1-23-18
(from Ph 1104.03)
Ph
1105.04 Audits.
(a) The board shall, at its annual January
meeting, randomly select at least 10 percent and not more than 20 percent of
active collaborative agreements for an audit.
(b) The continuing education advisory council
shall audit the continuing education requirements of randomly selected
collaborative practice agreements and submit its finding to the board at its
annual April board meeting.
(c) Audits shall include the elements outlined in
Ph 1104.
(d) Violations discovered by an audit shall be
reported to the board.
Source. #12464, eff 1-23-18
CHAPTER Ph 1200
CENTRAL PRESCRIPTION PROCESSING
PART Ph 1201
PURPOSE AND SCOPE
Ph
1201.01 Purpose. The purpose of this chapter is to set forth
the requirements, limitations, and prohibitions for pharmacies that engage in
central prescription processing so as to ensure that, for the protection of the
public, all central prescription processing activities regulated by the board
are performed in compliance with applicable state law and rules by those who
are licensed by the board.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1201.02 Scope. This chapter shall apply to all persons whose
activities come under the jurisdiction of
the board and who engage in central prescription processing activities.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
PART Ph 1202
DEFINITIONS
Ph 1202.01 “Central
fill pharmacy” means a licensed pharmacy, in this or any other state,
district or commonwealth of the United States, engaging in central prescription
handling by filling, refilling, or both, prescriptions including the
preparation, packaging, and labeling of the medication.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.02 “Central
prescription processing” means “central prescription processing” as defined in RSA
318: 1, XXIII, namely, “the processing by a pharmacy of a request from another
pharmacy to fill or refill a prescription drug order or to perform processing
functions, such as dispensing, drug utilization review, claims adjudication,
refill authorizations, and therapeutic interventions.”
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.03 “Central
processing pharmacy” means a licensed pharmacy, in this or any other
state, district, or commonwealth of the United States, that engages in
prescription review by performing functions that include but are not limited
to:
(a) Data entry;
(b) Prospective drug review;
(c) Refill authorizations;
(d) Therapeutic interventions;
(e) Patient counseling;
(f) Claims submission;
(g) Claims resolution; and
(h) Claims adjudication.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1202.04 “Claims adjudication” means
the process by which a prescription is submitted and processed through a
third-party payor.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1202.05 “Dispensing pharmacy” means a licensed pharmacy, in this or any other
state, district or commonwealth of the United States, that receives the
processed prescription, the filled or refilled prescription, or both, for
dispensing to the patient or to the patient’s authorized representative and
providing patient counseling as required.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.06 “Intake
pharmacy” means a licensed pharmacy, in this or any other state,
district or commonwealth of the United States, that receives the patient’s or
prescribing practitioner’s request to fill or refill a prescription, including
a central processing pharmacy or a central fill pharmacy, as defined below, if
the prescription was transmitted by the prescribing practitioner directly to
such pharmacy or if the patient requested the refill from that pharmacy.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
PART Ph 1203
CENTRAL PRESCRIPTION PROCESSING
Ph
1203.01 General Requirements for
Engaging in Central Prescription Processing. A pharmacy may perform or outsource central
prescription processing and handling services provided that:
(a) All pharmacies involved in the transactions
pursuant to which the prescription is dispensed shall have either:
(1) The same owner; or
(2) A written contract outlining the services to be provided and the
responsibilities and accountabilities of each party in fulfilling the terms of
the contract in compliance with federal and state laws, regulations, and rules;
(b) The pharmacies shall share a database to
allow access to information necessary or required to fill or refill a
prescription drug order;
(c) All participating pharmacies located in this
state shall maintain a pharmacy license for each location or if located in
another state shall be registered in New Hampshire as a mail-order pharmacy
according to Ph 900;
(d) All pharmacists participating in, providing,
or both, central prescription processing services shall be licensed in this
state or in the case of a non-resident pharmacy, the state in which the
pharmacy is located; and
(e) Each pharmacy and pharmacist engaging in
central prescription processing and handling shall be responsible for properly
filling the prescription and complying with the requirements of Ph 706 or each
relevant and applicable provision adopted by the state in which the pharmacy or
pharmacist is registered or licensed. If
such other state does not have a relevant or applicable provision, the owner or
contract referred to in (a) above shall comply with or require compliance with
the substance of Ph 706.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.02 Policy and Procedure Manual
Required.
(a) Each participating pharmacy performing or
contracting for the performance of centralized prescription processing and
handling shall maintain a paper or electronic policy and procedure manual that
includes at least the following:
(1) A policy that shall require
every participating intake pharmacy to keep a record that includes at least the
name, address and DEA number for each central fill or central processing pharmacy authorized to fill or process
prescriptions on its behalf;
(2) A policy that shall require each
central fill or central processing pharmacy to keep a record that includes at
least the name, address and DEA number of all intake pharmacies for which it is
authorized to fill or process prescriptions;
(3) A policy that shall describe
comprehensively the responsibilities of each of the participating intake,
filling, processing and dispensing pharmacies;
(4) A procedure that shall be used
for maintaining records sufficient to allow for tracking a prescription during
each stage of the filling and dispensing process including at least:
a. The following information about
the pharmacist(s) and technician(s) involved in filling and dispensing the
prescription and counseling the patient:
1. The pharmacist’s full name;
2. The state in which the pharmacist
is licensed and his or her license number; and
3. The action or actions taken by
the pharmacist; and
b. The following information about
the technician(s) involved in filling and dispensing the prescription:
1. The technician’s full name;
2. The state in which the technician
is licensed and the license number; and
3. The action or actions taken by
the technician;
(5) The policy and procedure that
shall be used for providing adequate security to protect the confidentiality
and integrity of patient information;
(6) The procedure that shall be used
by the pharmacy in implementing and operating a quality assurance program
designed to objectively and systematically monitor, evaluate, and improve the
quality and appropriateness of patient care; and
(7) The procedure that shall be
followed in dispensing a prescription drug order when the filled order is not
received or the patient comes in before the order is received.
(b) Each participating pharmacy and pharmacist
shall review the policies and procedures at least annually and such review
shall be documented.
(c) Each participating intake, processing,
filling and dispensing pharmacy and pharmacist shall make the policies and
procedures manual available to the board or its agents upon request.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.03 Patient Counseling. The dispensing pharmacy shall offer to counsel to the patient as required
pursuant to Ph 706.03.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.04 Prohibitions and Limitations.
(a) Prescriptions
for Schedule II controlled substances shall not be allowed for central
prescription filling but shall be filled and dispensed at the intake
pharmacy.
(b) Prescriptions for
Schedule III, IV, or V controlled substances shall be allowed for central
prescription processing and
filling.
(c) Prescriptions for legend or controlled
substances listed in Schedule III, IV, or V may be transmitted electronically, as permitted by state
and federal laws, including via facsimile, from an intake pharmacy to a central
fill pharmacy, provided that the intake pharmacy transmitting the prescription
information complies with all state and federal laws.
(d) An intake pharmacy transmitting prescription
information pursuant to (c) above shall keep:
(1) Records that track the
prescription drug order during each step in the filling process that shall
identify the name(s), initials, or identification code(s) and specific activity(ies)
of each pharmacist or pharmacy technician who performed any portion of the
process, including:
a. Transmission;
b. Filling;
c. Dispensing; or
d. Delivery to either the patient or
another pharmacy; and
(2) A record of the date the filled
prescription was delivered to the intake pharmacy, the method of delivery, such
as by private, common or contract carrier, and the identity of the carrier.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.05 Record Keeping.
(a) The common electronic database shall maintain
a record of all pharmacists and pharmacies involved in the intake, processing,
filling, and dispensing of all prescriptions.
(b) There shall be record keeping systems between
central prescription processing pharmacies with real-time, online access to those
services provided by each pharmacy.
(c) Access to prescription information by 2
participating pharmacies shall not be considered a prescription transfer and
shall not be subject to the provisions of Ph 704.04.
(d) All records required to be created and
maintained pursuant to Ph 1203 shall be maintained for a period of not less
than 4 years.
Source. #9469, eff 5-16-09,
EXPIRED: 5-16-17
New. #12485, eff 2-24-18
CHAPTER Ph 1300 PHARMACIST ADMINISTRATION OF VACCINES
PART Ph 1301 PURPOSE AND SCOPE
Ph
1301.01 Purpose. The purpose of this chapter is to implement and
regulate pharmacist administration of vaccines as a means to make vaccinations
more easily accessible and therefore providing immunity to a larger patient
population.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
Ph
1301.02 Scope. These rules shall regulate pharmacist
administration of vaccines where the practice of pharmacy is permitted.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
PART Ph 1302 DEFINITIONS
Ph
1302.01 “Administer” means “administer”
as defined in RSA 318:1, I, namely, “an act whereby a single dose of a drug is
instilled into the body of, applied to the body of, or otherwise given to a
person or animal for immediate consumption or use.”
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
Ph
1302.02 “Licensed pharmacist” or
“pharmacist” means “licensed pharmacist” or “pharmacist” as defined in RSA
318:1, VII, namely, “when not otherwise limited, means a person holding a
license under RSA 318:18 and who is, therefore legally authorized to practice
the profession of pharmacy in this state.”
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
Ph
1302.03 “Practitioner” or “licensed
practitioner” means “practitioner” or “licensed practitioner” as defined in RSA
318:1, XV, namely, “means any person who is lawfully entitled to prescribe,
administer, dispense, or distribute legend drugs to patients.”
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
PART Ph 1303 PHARMACIST ADMINISTRATION OF VACCINES
QUALIFICATIONS AND APPLICATION
Ph
1303.01 Qualifications.
(a) A pharmacist who seeks to engage in the
administration of vaccines shall meet the requirements of:
(1)
RSA 318:16-b, I, relative to education or experience;
(2)
RSA 318:16-b, II, relative to professional liability insurance coverage;
and
(3)
RSA 318:16-b, III, relative to completion of continuing education.
(b) A pharmacist who seeks to engage in the
administration of vaccines shall hold current basic or higher certification in
cardiopulmonary resuscitation (CPR) from the American Heart Association, the
American Red Cross, or from another organization or entity that is
nationally-recognized as an issuer of such certifications.
(c) A pharmacist shall not delegate the
administration of vaccines to any person.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
Ph
1303.02 Application.
(a) A pharmacist who seeks to engage in the
administration of vaccines shall file a completed “Pharmacist Administration of
Vaccines Application” (February 2015) as
specified in RSA 318:16-b, IV.
(b) An application fee of $25.00 shall be filed
with the board and included with the above application.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12; ss by #10842, eff 6-3-15
PART Ph 1304 PHARMACIST ADMINISTRATION OF VACCINES
PROCEDURAL AND RECORDKEEPING REQUIREMENTS
Ph
1304.01 Vaccine Administration
Requirements. A pharmacist who
engages in the administration of vaccines shall comply with the following
procedures:
(a) Provide the patient with a Vaccine
Information Statement (VIS) as provided by the Centers for Disease Control
(CDC);
(b) Ensure that the patient has received and
signed the Patient Consent Form and has been counseled and his or hers
questions answered prior to administration of the vaccine;
(c) Maintain and follow written policies and
procedures that establish a course of action the pharmacist shall follow to
address:
(1)
Adverse reactions;
(2)
Anaphylactic reactions including a standard order for treatment;
(3)
Accidental needle sticks; and
(4)
Handling/disposal of used or contaminated equipment and supplies;
(d) Report all adverse events to the Vaccine Adverse
Events Reporting System (VAERS) and to the primary care physician if
applicable;
(e) Provide the patient with documentation of the
vaccination and when appropriate report it to the immunization section of the
(f) Provide notice electronically, in writing or
fax by within 30 days to the primary
care provider, when the practitioner has been designate
(g) Be able to recognize anaphylaxis and maintain
at least 2 doses of injectable epinephrine at all times to treat a reaction if
it occurs.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
Ph
1304.02 Recordkeeping. A pharmacist who engages in the administration
of vaccines shall, for a minimum of 4 years, keep a patient consent form that
includes the:
(a) Name and date of birth of the patient;
(b) Name of the vaccine, manufacturer, lot
number, and expiration date of the vaccine;
(c) Description of the risks and possible side
effects of the vaccine;
(d) Date of administration;
(e) Administering pharmacist’s name; and
(f) Signature of the patient.
Source. #9552, eff 9-23-09;
ss by #10185, eff 9-18-12
CHAPTER Ph 1400 UNUSED PRESCRIPTION DRUG PROGRAM RULES
PART Ph 1401 PURPOSE
Ph 1401.01 Purpose: The purpose of the rule is to allow the voluntary
donation of unused prescription drugs and
medical devices to the uninsured and the underinsured individuals.
(a) The rules of Ph 1400 describe the program to
take unused prescription drugs and medical devices donated from nursing homes,
pharmaceutical manufacturers, and other eligible donators and utilize them for
dispensing to uninsured and underinsured persons who opt into the program.
(b) The rules of Ph 1400 describe the eligibility
to donate. They describe the eligible
prescription drug formulary, the eligible recipients, and the protection for
participants. They describe pharmacies eligible to accept and dispense such
drugs, and medical devices the requirements for eligible pharmacies, and the
responsibilities for consultant pharmacists.
(c) The rules of Ph 1400 describe safe handling
of drugs and medical devices to protect drug integrity, tracking,
sanitation, security and dispensing requirements for these unused prescription
drugs and medical devices. The rules of
Ph 1400 describe confidentiality requirements as well as violations.
Source. #10064, eff 12-28-11
PART
Ph 1402 DEFINITIONS
Ph 1402.01 “Abandoned drug” means a prescription only drug that was dispensed for a patient
that was never in a patient’s possession and is no longer needed by the patient
or was left behind at a facility after discharge from the facility. The term
includes Patient Assistance Program drugs when the manufacturer does not
provide a shipping-paid option for the provider to return the drug to the
manufacturer or the manufacturer’s agent and:
(a)
The provider has determined and documented that the patient should not
receive or is unable to receive the drug, or
(b)
The patient has not returned to receive the drug within 8 weeks of the
time the prescriber received the drug.
Source. #10064, eff 12-28-11
Ph 1402.02 “Agent”
means any person who is legally authorized to make medical decisions for a
patient.
Source. #10064, eff 12-28-11
Ph 1402.03 “Charitable Provider” means any pharmacist or practitioner
licensed by this state to dispense drugs as defined by RSA 318:42 who chooses
to participate in an unused prescription drug program.
Source. #10064, eff 12-28-11
Ph 1402.04 “Dispense” means to distribute, leave with, give away, dispose of, deliver,
or sell one or more doses of a drug that will be administered or taken at a
later date, time, or location and the transfer of more than a single dose of a
medication from one container to another and the labeling or otherwise
identifying a container holding more than a single dose of a drug.
Source. #10064, eff 12-28-11
Ph 1402.05 “Donate” means the giving free of charge of an eligible prescription drug to an
unused prescription drug program.
Source. #10064, eff 12-28-11
Ph 1402.06 “Eligible prescription drug ” (EPD) means any unused prescription only drug that
has not reached its expiration date, is contained in an unopened unit dose or
other tamper evident packaging, has not been in the possession of the patient
and has been stored properly and is not a radiopharmaceutical therapeutic or
diagnostic drug. Drugs that can only be
dispensed to a patient registered with the drug’s manufacturer in accordance
with federal Food and Drug Administration (FDA) requirements are not eligible
for the program.
Source. #10064, eff 12-28-11
Ph 1402.07 “Manifest” means an itemized invoice of EPD donated, accepted or destroyed.
Source. #10064, eff 12-28-11
Ph 1402.08 “Pharmacy” means “pharmacy” as defined by RSA 318:1 XI.
Source. #10064, eff 12-28-11
Ph 1402.09 “Practitioner” or "licensed practitioner'' as defined by RSA 318:1 XV.
Source. #10064, eff 12-28-11
Ph 1402.10 “Program Pharmacist” means any licensed pharmacist in
Source. #10064, eff 12-28-11
Ph 1402.11 “Redispense” means to dispense an EPD that was accepted by an unused
prescription drug program for the purpose of providing medication to an
individual who is uninsured/underinsured.
Source. #10064, eff 12-28-11
Ph 1402.12 “Underinsured” means a person who lacks
adequate prescription related insurance coverage such that purchasing
prescription drugs and/or devices create a financial hardship.
Source. #10064, eff 12-28-11
Ph 1402.13 “Uninsured” means a person who does not
presently have an active insurance policy that reimburses fully or partially
for prescription drugs or devices.
Source. #10064, eff 12-28-11
PART Ph 1403 ELIGIBILITY TO DONATE PRESCRIPTION DRUGS
(EDP) AND MEDICAL DEVICES
Ph 1403.01 Eligible Donating Entities. The following entities shall be eligible to donate
prescription drugs and medical devices:
(a)
A pharmacy;
(b) A licensed practitioner;
(c)
A Hospice or outpatient clinic if licensed pursuant to RSA 151;
(d) A New Hampshire nursing home, if it is licensed with the New Hampshire department of health and
human services (DHHS) and has a
consultant pharmacist or program pharmacist;
(e) A licensed
manufacturer/wholesaler/distributor, who voluntarily donates samples or eligible prescription drugs or medical devices
to eligible charitable providers in this program; and
(f) A state
or county correctional facility if it has a program pharmacist.
Source.
#10064, eff
12-28-11
Ph 1403.02 Unused Prescription Property.
(a) A prescription drug shall be the property of
the patient for whom it is prescribed, regardless of who paid for the
prescription.
(b) The patient or agent of the patient may at
any time authorize the donation of the unused prescription drugs or medical
device.
(c) An unused prescription may be donated:
(1)
When a patient has died and
(2)
When a drug is abandoned.
(d) Prescription drugs donated under Ph 1400
shall only be transferred to charitable providers.
(e)
Prescription drugs or medical devices donated under Ph 1400 shall not be
sold, resold, offered for sale, traded, or returned for financial credit. This
shall not prohibit transfer between charitable providers.
(f) A charitable provider shall be responsible
for determining that the patient has authorized the donation of the drugs or
medical devices.
(g) A charitable provider shall make certain that
the name of the patient, and all patient information and directions on the
label will be redacted or removed before sending to the accepting entity to
protect confidentiality.
(h) Manifests shall be maintained for internal and
external transfer of product.
Source. #10064, eff 12-28-11
Ph 1403.03 Conditions
Required for Unused Prescription Drugs.
The following conditions shall apply to unused prescription drugs and
medical devices.
(a)
Licensed healthcare personnel shall in order
to be eligible keep control of such unused prescription drugs and medical
devices in sanitary and secure conditions as required under RSA 318:58.
(b) Such unused prescription drugs and medical
devices, in sanitary and secure conditions shall be eligible for donation.
(c) Nursing homes shall have a consultant
pharmacist or a program pharmacist.
Source. #10064, eff 12-28-11
PART
Ph 1404 ELIGIBILITY TO ACCEPT DONATIONS
(EAD)
Ph 1404.01 Eligible Accepting Entities. The following entities shall be eligible to
accept unused prescription drugs and medical devices.
(a)
A pharmacy;
(b)
A licensed practitioner;
(c)
A hospice
or public health clinic including (
(d)
(e) A manufacturer/wholesaler/distributor may accept samples or eligible
prescription drugs for eligible charitable providers in this program; and
(f) A state or county correctional facility if it
has a program pharmacist or a charitable provider.
Source. #10064, eff 12-28-11
PART
Ph 1405 ELIGIBILITY TO REDISPENSE
Ph 1405.01 Eligible Redispensing Entities. Entities that are eligible to redispense
shall include:
(a)
A pharmacy; and
(b) Any licensed prescriber.
Source. #10064, eff 12-28-11
PART
Ph 1406 PROGRAM PHARMACIST
RESPONSIBILITIES
Ph 1406.01 Program Pharmacist.
(a)
All entities eligible to accept shall have the program
pharmacist approved by the
(b)
Program pharmacists for the nursing home eligible to donate unused
prescription drugs and medical devices shall:
(1) Review quality and suitability of the unused
prescription drugs for reuse as follows:
a. The drugs and medical devices shall be kept
under the control of a health care professional;
b. The drugs and medical devices shall be stored
properly against heat, cold and moisture;
c. The drugs shall be identifiable; and
d. The drugs are not adulterated, misbranded or
mutilated.
(2) Determine that the expiration date exceeds 90
days to allow time for redistribution;
(3) Make sure a manifest contains the following
if applicable: supplier (donor) name,
and receiver name, donor and receiver address, phone numbers, state permit
numbers, signatures, date sent, date received, date destroyed, name, strength
and dosage form of drug, NDC #, package size, quantity, initials;
(4) Provide a copy of this manifest to the
accepting entity and maintain a copy at the donating entity for at least 2
years;
(5) Assure controlled substances, that is, Drug Enforcement
Agency (DEA) controlled substances are not donated or accepted;
(6) Assure that the accepting and donating
entities are eligible to receive unused prescription drugs and medical devices
under these rules; and
(7) Have transportation of product and manifest
be the responsibility of both the donating and accepting entities to ensure
that product integrity is maintained.
Source. #10064, eff 12-28-11
PART Ph 1407 ELIGIBLE
PRESCRIPTION DRUG FORMULARY
Ph
1407.01 Formulary. All Food and
Drug Administration (FDA) approved prescription drugs excluding controlled
substances shall be subject to the following:
(a)
They shall not have been in
the possession of the patient or other member of the public;
(b)
They shall not have reached within 90 days of their expiration date;
(c)
They shall be contained
in unopened unit dose or other tamper-evident packaging and show no evidence of
contamination;
(d)
Medical devices shall not be unsanitary, broken, dangerous or otherwise
unfit for practical use;
(e)
They shall not be compounded drugs;
(f)
Drugs that require storage temperatures other than normal room
temperature as specified by the manufacturer shall only be donated or accepted
if the program pharmacist(s) can ascertain the proper storage has been
maintained at all times and transferred internally under the same ownership;
and
(g)
Drugs that can only be dispensed to a patient registered with the drug’s
manufacturer in accordance with federal Food and Drug Administration (FDA)
requirements shall not be accepted or distributed.
Source. #10064, eff 12-28-11
PART Ph 1408 REQUIREMENTS FOR PHARMACIES DISPENSING UNUSED
PRESCRIPTION DRUGS
Ph 1408.01 Dispensing Requirements. Unused prescription drugs shall be dispensed
in compliance with the following:
(a)
Pharmacies shall follow the requirements established in RSA 318;
(b)
(1) Maintain a current drug identification book,
or shall have a current computer program or online service for the same;
(2) Provide information to all recipients
regarding the program and maintain a participation consent form for each
eligible recipient or patient representative agent of any unused prescription
drug; and
(3) Maintain samples in the original package as
required under federal law, and the samples shall not be removed from original
packaging for dispensing.
(c) If it is determined by the pharmacist’s
professional judgment that it would be best for the patient, the drugs can be
removed from patient specific packaging or unit dose packaging (UDP), commonly
referred to as bingo cards, and repackaged.
(d) Eligible
(1)
They may limit the number of prescriptions per patient per visit or per
month, to allow a greater number of individuals access to such prescription
drugs;
(2) If
no underinsured or uninsured patients are available, donated medications may be
made available to other patients; and
(3)
There shall be a written policy that is enforced equally to prevent
discrimination.
(e) Pharmacies may transfer unused prescription drugs
to another pharmacy in the program when one pharmacy has the need for a drug
and another pharmacy has it available. The transferring pharmacy shall follow
the rules of the donating entity and the receiving pharmacy shall follow the
rules of the accepting entity.
(f) Unused prescription drugs and medical devices
shall not be resold.
Source. #10064, eff 12-28-11
PART Ph 1409 RESPONSIBILITIES OF CHARITABLE PROVIDERS
Ph 1409.01 Charitable Providers. A charitable provider shall:
(a) Coordinate
retrieval of donated unused prescription drugs and medical devices from
entities eligible to donate;
(b) Check
unused prescription drugs (UPD) against the manifest and document any
discrepancies and communicate those discrepancies to the entity eligible to
donate;
(c) Store
and secure these UPDs in a manner that distinguishes them from general stock
and store them according to state and federal laws, rules and regulations;
(d) Check
the unused prescription drugs for adulteration or misbranding;
(e) Assure
expired, adulterated, misbranded, and controlled drugs are not dispensed;
(f) Segregate unacceptable drugs for destruction
or return and prepare a manifest that is signed by both the pharmacist and a witness when it comes
time for destruction;
(g) Have access to FDA or manufacturer drug
recall information. If a drug is recalled by the FDA or manufacturer and the eligible provider can not ascertain the lot
number on the label to differentiate between the recall and non-recalled drug,
all such donated drugs shall be
considered recalled and destroyed or returned in the manner specified by the
recall; and
(h) Assure destruction as defined by Department
of Environmental Service of expired, adulterated, and/or recalled unused
prescription medications as
follows:
(1) A
manifest shall be made of unused prescription drugs expired, adulterated,
misbranded and/or recalled to be destroyed;
(2)
Following destruction such manifest shall be signed by the pharmacist
and witness verifying such destruction; and
(3) The
drug destruction manifest shall be kept in the files of the pharmacy for at
least 2 years.
Source. #10064, eff 12-28-11
Ph 1409.02 Labeling. Dispensed prescription(s) shall clearly indicate
the final charitable provider and the current patient information to assure
clarity for receiving patient and shall be properly labeled according to RSA
318:47 and shall include the expiration date.
Source. #10064, eff 12-28-11
Ph
1409.03 Handling Fee. Whenever possible the dispensing facility or
service shall provide at least a 30 day supply and a handling fee may be
charged according to RSA 318:58 V.
Source. #10064, eff 12-28-11
Ph 1409.04 Recordkeeping. Charitable providers shall comply with
recordkeeping rules set forth by Ph 309.07.
Source. #10064, eff 12-28-11
PART Ph 1410 FORMS
Ph 1410.01 Transfer Manifests.
(a)
Sample manifests shall be available by the
(b)
All participants may use their own manifest, provided they include all
current information listed on the current manifest. See Ph 1406.01 (b) (3).
Source. #10064, eff 12-28-11
PART Ph1411
PARTICIPANT IMMUNITY
Ph
1411.01 Participant Immunity. Immunity shall be provided to the program as
provided in RSA 318:60.
Source. #10064, eff 12-28-11
PART Ph 1412 VIOLATIONS
Ph 1412.01 Violations of the Unused Prescription Drug
Program.
(a) Theft
or diversion of any of the unused prescription drugs shall be a violation of
these rules. This shall include
any expired, misbranded drug, adulterated drug, recalled drug, or other drug
found to be unusable under the requirements of Ph 1400.
(b) Any violation by any person of the unused
prescription drug program shall be reported by the licensed entity upon
discovery to the appropriate licensing agency within 30 days and/or other
proper authorities for possible action.
(c) Such violation by any person licensed by the
board may result in action under RSA 318:55 or any licensee, permittee, registrant or certificate
holder as provided in RSA 318:29.
Source. #10064, eff 12-28-11
CHAPTER Ph 1500
NEW HAMPSHIRE CONTROLLED DRUG PRESCRIPTION HEALTH AND SAFETY PROGRAM
PART Ph 1501
PURPOSE
Ph
1501.01 Purpose. This rule implements the New Hampshire Controlled
Drug Prescription Health and Safety Program created by RSA 318-B:31–38, which
authorizes the pharmacy board to establish and contract with a third party for
the implementation and operation of an electronic system to facilitate the
confidential sharing of information relating to the prescribing and dispensing
of schedule II–IV controlled substances by prescribers and dispensers within
the state to promote public health and safety through the prevention of and
treatment for misuse and abuse of controlled substances and the reduction of
the diversion of such substances, without interfering with the legal medical
use of these substances.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
PART Ph 1502
DEFINITIONS
Ph
1502.01 Definitions.
(a) “Authorized representative” means a parent or
guardian of a minor child, or a person who has been authorized in the manner
required by law to make health care decisions, or gain access to health care
records, on behalf of another.
(b) “Board” means “board” as defined in RSA
318-B:31, I, namely, “the pharmacy board, established in RSA 318:2.”
(c) “Controlled substance” means “controlled
substance” as defined in RSA 318-B:31, II, namely, “controlled drugs as defined
in RSA 318-B:1, VI.”
(d) “Credential” means information or a device
provided by the program to a registered dispenser or prescriber that allows the
dispenser or prescriber to electronically submit or access prescription
monitoring information. Credentials
include, but are not limited to, a user name and password, or an identification
device that generates a user name and password.
(e) “Dispense” means “dispense” as defined in RSA
318-B:31, III, namely, “to deliver a controlled substance by lawful means and
includes the packaging, labeling, or compounding necessary to prepare the
substance for such delivery.”
(f) “Dispenser” means “dispenser” as defined in
RSA 318-B:31, IV, namely, “a person lawfully authorized to deliver a schedule
II-IV controlled substance, but does not include:
(1) A licensed
hospital pharmacy that dispenses less than a 48 hour supply of a schedule II-IV
controlled substance from a hospital emergency department, or that dispenses
for administration in the hospital;
(2) A
practitioner, or other authorized person who administers such a substance;
(3) A wholesale
distributor of a schedule II–IV controlled substance or its analog;
(4) A
prescriber who dispenses less than a 48 hour supply of a schedule II – IV
controlled substance from a hospital emergency department to a patient; or
(5) A
veterinarian who dispenses less than a 48 hour supply of a schedule II-IV
controlled substance to a patient.”
(g) “Patient” means “patient” as defined in RSA
318-B:31, V, namely, “the person or animal who is the ultimate user of a
controlled substance for whom a lawful prescription is issued and for whom a
controlled substance or other such drug is lawfully dispensed.”
(h) “Person” means “person” as defined in RSA
318-B:1, XXI, namely, “any corporation, association or partnership, or one or
more individuals.”
(i) “Practitioner” means “practitioner” as
defined in RSA 318-B:31, VI, namely, “a physician, dentist, podiatrist,
veterinarian, pharmacist, APRN, physician assistant, naturopath, or other
person licensed or otherwise permitted to prescribe, dispense, or administer a
controlled substance in the course of licensed professional practice.”
(j) “Prescribe” means “prescribe” as defined in
RSA 318-B:31, VII, namely, “to issue a direction or authorization, by
prescription, permitting a patient to lawfully obtain controlled substances.”
(k) “Prescriber” means “prescriber” as defined in
RSA 318-B:31, VIII, namely, “a practitioner or other authorized person who
prescribes a schedule II, III, and/or IV controlled substance.”
(l) “Program”
means “program” as defined in RSA 318-B:31, IX, namely, “the controlled drug
prescription health and safety program that electronically facilitates the
confidential sharing of information relating to the prescribing and dispensing
of controlled substances listed in schedules II-IV, established by the board
pursuant to RSA 318-B:32.”
(m) “Program manager” means the person designated
by the board to oversee the implementation and operation of the program by the
program vendor.
(n) “Program vendor” means a third party with
which the board contracts for the implementation and operation of the program.
(o) “Regulatory board” means the New Hampshire
board of dentistry, board of medicine, board of nursing, board of registration
in optometry, board of podiatry, board of veterinary medicine, and pharmacy
board.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
PART Ph 1503 REGISTRATION
OF PRESCRIBERS AND DISPENSERS
Ph
1503.01 Registration of Prescribers
and Dispensers.
(a) All practitioners authorized to prescribe or
dispense schedule II–IV controlled substances within the state of New Hampshire
shall register with the program [no later than June 30, 2015], as follows:
(1)
Practitioners who prescribe but do not dispense schedule II-IV
controlled substances shall register with the program as a prescriber;
(2) Practitioners
who dispense but do not prescribe schedule II-IV controlled substances shall
register with the program as a dispenser if they fall under the definition of
“dispenser” in RSA 318-B:31, IV; and
(3)
Practitioners who prescribe and dispense schedule II-IV controlled
substances shall register with the program as both a prescriber and a dispenser
unless exempted pursuant to RSA 318-B:31, IV.
(b) Program registration shall be by one of the
following methods:
(1) Automatic
registration at the time of the program go-live date or at the time of initial
licensure or license renewal, if permitted by the prescriber’s or dispenser’s
regulatory board; or
(2) Completing
and submitting to the program vendor a registration form provided by the
program vendor.
(c) Before a program credential is issued, the
registrant shall be verified as having a current and valid license, as follows:
(1) Those
prescribers and dispensers who register in accordance with (b)(1) above shall
be automatically verified; and
(2) Those
prescribers and dispensers who register in accordance with (b)(2) above shall
be verified by the program manager by confirming that the registrant has a
valid license.
(d) On a monthly basis, each regulatory board
shall submit to the program manager or program vendor a list of prescribers and
dispensers:
(1) Who have
been issued a new license;
(2) Whose
license has been renewed; and
(3) Who have had
their license revoked, suspended, restricted, or not renewed.
(e) If the credentials issued by the program
vendor are lost or missing, or if the security of the credentials is
compromised, the prescriber or dispenser shall cause the program manager to be
notified by telephone and in writing as soon as possible.
(f) Those dispensers licensed under RSA 318 who
have not registered shall be subject to disciplinary action as established
pursuant to RSA 318:29.
(g) Those prescribers and dispensers who are
required to register but who have not done so shall, pursuant to RSA 318-B:36
III, be subject to penalties established by their respective regulatory board.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
PART Ph 1504
REQUIREMENTS FOR DISPENSERS
Ph
1504.01 Reporting of Controlled
Substances Dispensed.
(a) Dispensers shall submit to the program the
prescription drug monitoring information required by RSA 318-B:33, IV, and
paragraph (b) below, for each dispensing of a schedule II–IV controlled
substance, as follows:
(1) Electronically, through
direct upload to the program software or website at https://pmpclearinghouse.net, unless a waiver is
requested and granted in accordance with Ph 1504.02(a) below;
(2) Daily, by
the close of business on the next business day after the prescription was
dispensed, unless an extension is requested and granted in accordance with Ph
1504.03 below, with the following exceptions:
a. Veterinarians
shall submit the information required under (a)(2) above no more than 7 days
from the date the prescription was dispensed; and
b. Dispensers
who have a federal Drug Enforcement Administration license but who do not
dispense controlled substances may request a waiver as described in Ph
1504.02(c) below; and
(3) For
registered dispensers located outside the state of New Hampshire, information
only for patients who reside in New Hampshire.
(b) The required prescription drug monitoring
information to be submitted shall be as follows:
(1) Dispenser’s
Drug Enforcement Administration (DEA) registration number and, if available,
the dispenser’s National Provider Identification (NPI) number;
(2) Prescriber’s
DEA registration number and, if available, the prescriber’s NPI number;
(3) Date of
dispensing;
(4)
Prescription number;
(5) Number of
refills granted;
(6) National
Drug Code (NDC) of drug dispensed;
(7) Quantity
dispensed;
(8) Number of
day’s supply of drug;
(9) Patient’s
name, including first name, middle initial, if applicable, last name, and,
suffix, if applicable;
(10) Patient’s
address;
(11) Patient’s
date of birth, or, for animals, the owner’s date of birth;
(12) Patient’s
phone number, if available;
(13) Date
prescription was written by prescriber;
(14) Whether
the prescription is new or a refill;
(15) Source of
payment for prescription; and
(16) The
species code human (1) or animal (2), and if animal, the animal’s name.
(c) Dispensers licensed by the board under common
ownership, including those located outside of New Hampshire, may submit the
required prescription drug monitoring information in (b) above in a single
joint report provided that each dispenser is clearly identified for each
prescription dispensed.
(d) The program vendor shall perform data checks
to ensure that the required prescription drug monitoring information submitted
is accurate, complete, and timely.
(e) The program vendor shall notify the
dispenser, the program manager, and the board:
(1) When the
dispenser fails to submit the required prescription drug monitoring information
within the required timeframe;
(2) When there are
inaccuracies or omissions in the required prescription drug monitoring
information submitted; and
(3) When a
dispenser fails to correct any inaccuracies or omissions.
(f) Dispensers shall:
(1) Correct any
failures, inaccuracies, or omissions, within 72 hours of the date of receipt
of notice from the program vendor;
(2) Correct
their own records and submit corrected information to the program or program
vendor whenever they become aware of errors, omissions, or reversals;
(3) Comply with
any provision of this section or be subject to disciplinary action as
established pursuant to RSA 318:29; and
(4) If a
dispenser has no dispensing transactions to report for the preceding reporting
period, report this information to the New Hampshire Controlled Drug
Prescription Health and Safety Program by filing a “zero report,” as described
in the Reporting Zero Dispensing topic in the Data Submission Dispenser Guide,
effective June 29, 2017.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph
1504.02 Waivers.
(a) Dispensers that are unable to electronically submit,
through direct upload to the program software or secure website, the required
prescription drug monitoring information may request a waiver to submit the
information by other means by completing and submitting a “Request for Waiver
of Reporting Requirements for New Hampshire Prescription Drug Monitoring
Program” form, effective October 28, 2016, to the program manager, along with
any supporting documentation.
(b) A waiver request submitted pursuant to (a)
above shall:
(1) Demonstrate
that, for any reason, including low volume of controlled substances being
dispensed, financial hardship will result from the requirement of electronic
submission[.]; and
(2) Include an
alternative method by which the dispenser will submit the required
prescription drug monitoring information with the time frame specified in Ph
1504.01(a)(2). Alternative methods of
submission shall include but not be limited to, e-mail, flash drive, CD, or
paper.
(c) Dispensers that are authorized to dispense
schedule II-IV controlled substances, but do not do so, may request a waiver
from the program submission requirements by completing and submitting a
“Request for Waiver of Reporting Requirements for New Hampshire Prescription
Drug Monitoring Program” form, effective October 28, 2016, provided that such
dispensers demonstrate that no schedule II-IV controlled substances have been
dispensed in the 3 months immediately preceding the waiver request.
(d) Dispensers shall be notified of the decision
to grant a waiver within 30 days of the date of the receipt of the completed
waiver request.
(e) A waiver shall be specific to one United
States DEA number and non-transferable.
(f) A waiver shall be time-limited, not to exceed
the dispenser’s license expiration date.
(g) A waiver shall be subject to revocation if
the bases for granting the waiver are determined to be no longer true.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph
1504.03 Extensions.
(a) Dispensers that are unable to submit required
prescription information within the required timeframe may request from the program
manager an extension of the timeframe by telephone confirmed by email from the
program manager.
(b) The program manager shall allow an extension
for as long as the dispenser is making a good-faith effort to submit the
required information, but no later than 10 calendar days after the established
7 day timeframe.
(c) The program manager shall notify the board if
a dispenser ceases to demonstrate good faith in its efforts to submit the
required information or if the dispenser fails to submit the required
information by the extended timeframe.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
PART Ph 1505
ACCESS TO PRESCRIPTION DRUG MONITORING INFORMATION
Ph
1505.01 Patient Access.
(a) A patient for whom a prescription for a
schedule II–IV controlled substance is dispensed, or his or her authorized
representative, may request and obtain a report listing all prescription
monitoring information that pertains to that patient.
(b) The request in (a) above shall be submitted
to the program manager, either by mail or in person, on a complete, “Patient
Prescription Monitoring Information Request” form (February 2014 Edition)
signed by the patient, or the patient’s authorized representative.
(c) Patient information shall not be mailed or
otherwise transmitted to the patient, or the patient’s authorized
representative, except as allowed by (d) below.
(d) Upon notice that the requested information is
available, the patient, or the patient’s authorized representative, shall
receive the information in person, only after he or she produces valid
government-issued photographic proof of identity. With the consent of the patient, or the
patient’s authorized representative, the program manager shall photocopy the
identification. If the patient, or patient’s authorized representative, does
not consent to the photocopying of the identification, the patient, or
patient’s authorized representative, shall provide written verification
attesting to their identity.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph
1505.02 Prescriber and Dispenser
Access.
(a) Registered prescribers and dispensers, or their
designees, and federal health prescribers and dispensers working in federal
facilities located in New Hampshire, Massachusetts, Maine, and Vermont shall
have electronic program access to information on a specific patient, and in the
case of veterinarians a specific patient’s owner(s), both past and present, for
which a prescription was written or an appointment was scheduled or conducted.
(b) Requests shall be made by electronically or
in writing.
(c) Electronic requests shall be made through the
program’s secure web portal.
(d) Written requests shall:
(1) Be made by
submitting to the program a completed “NH Prescriber/Dispenser Prescription
Monitoring Information Request” form, effective 11/2017; and
(2) Be fulfilled
by secure mail or fax.
(e) To enable the timely and efficient delivery
of medical or pharmaceutical care for a specific patient, a prescriber or
dispenser registered with the program may delegate the task of retrieving
program information for a specific patient to an individual working under the
direction and supervision of the registered prescriber or dispenser provided
that written documentation of the delegation to the individual is provided to
the program. Both the prescriber or
dispenser who authorized the delegation and the individual to whom the task of
retrieving the program information was delegated shall be subject to the
provisions and penalties in RSA 318-B:36 regarding proper access to and use of
program information.
(f) All program information, as listed in Ph
1504.01(b), to the extent that it is medical information shall be treated and
protected as all protected health information.
(g) The program information may be placed in the
patient medical records.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph
1505.03 Law Enforcement Access.
(a) Authorized law enforcement officials may
request and obtain information from the program on a case-by-case basis for the
purpose of investigation and prosecution of a criminal offense.
(b) For the purposes of (a) above, a law enforcement
official shall be considered authorized if he or she provides a court order
based on probable cause, or a search warrant signed by a judge, which includes
sufficient information to correctly identify the patient, prescriber, or
dispenser whose prescription monitoring information is the subject of the court
order.
(c) A law enforcement official shall present the
court order or search warrant to the representative of the board designated by
the board to receive such orders, who shall notify the program manager to
provide the information identified in the court order in the format requested
by the court order.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph 1505.04 Regulatory
Board Access.
(a) New Hampshire regulatory boards, and
equivalent out-of-state boards, may request and obtain information from the
program, provided, however, that the request is pursuant to the regulatory
board’s official duties and responsibilities and the disclosures to each
regulatory board relate only to its licensees and only with respect to those
licensees whose prescribing or dispensing activities indicate possible
fraudulent conduct.
(b) Requests in (a) above shall be in writing,
signed by the regulatory board’s executive director, investigator, or other
person authorized to discharge equivalent functions of the regulatory board,
and sent to the program manager via mail or electronically as an email
attachment or facsimile.
(c) The address for the program shall be:
Pharmacy Board
Program Manager
Prescription Drug Monitoring Program
121 South Fruit Street
Concord New Hampshire 03301
(603) 271-2856 (fax)
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph
1505.05 Other Access.
(a) Requests in (b) - (c) below shall be
completed electronically via email or facsimile, or legibly in ink, signed by
an authorized individual, and sent to the program manager at the address in Ph
1505.04(c).
(b) Out-of-state prescription drug monitoring
programs may request and obtain information from the program on a case-by-case
basis provided that an agreement is in place with the other state to ensure
that the information is used and disseminated pursuant to the applicable
requirements of the NH controlled drug prescription health and safety program.
(c) Entities that operate a secure interstate
prescription drug data exchange system for the purpose of interoperability and
the mutual secure exchange of information among prescription drug monitoring
programs may request and obtain information from the program on a case-by-case
basis provided that an agreement is in place with the entity to ensure that the
information is used or disseminated pursuant to the applicable requirements of
the NH controlled drug prescription health and safety program.
(d) The office of the chief medical examiner may
request and obtain information from the program on a case by case basis to
determine the cause of death of an individual, provided the information is used
or disseminated pursuant to the applicable requirements of the NH controlled
drug prescription health and safety program.
(e) Requests in (d) above shall be made by
submitting a board provided “NH Medical Examiner Office PDMP Data Request
Form,” effective August 2016.
Source.
#10526, eff
2-26-14; ss by #12465, eff 1-23-18
PART Ph 1506 REVIEW AND REPORTING OF PRESCRIPTION DRUG
MONITORING INFORMATION
Ph
1506.01 Review of Program Data.
(a) The program vendor shall collect and monitor
all prescription drug monitoring information required by RSA 318-B:33, IV, and
Ph 1504.01(b).
(b) The program vendor shall review and evaluate
the collected information in order to identify behavior that suggests possible
drug abuse, misuse, or diversion, or possible violations of law or breaches of
professional standards.
(c) The program vendor shall consider, at a
minimum, the following patient-related factors in its evaluation in (b) above:
(1) Number of
in-state prescribers;
(2) Number of
out-of-state prescribers;
(3) Number of
prescriptions;
(4) Number of
doses;
(5) Overlapping
prescriptions;
(6) Unhealthy
combinations of controlled substances;
(7) Method of
payment;
(8) Number and
frequency of pharmacies used; and
(9) Dangerous
levels of controlled substances.
(d) The program vendor shall consider, at a
minimum, the following prescriber/dispenser–related factors in its evaluation
in (b) above:
(1) Number of
prescriptions;
(2) Number of
doses;
(3) Overlapping
prescriptions;
(4) Unhealthy
combinations of controlled substances;
(5) Number and
frequency of pharmacies used;
(6) Dangerous
levels of controlled substances;
(7) Electronic program
access and use; and
(8) For
dispensers only, method of payment.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
Ph 1506.02 Reporting
of Program Data.
(a) The program shall report to the appropriate
regulatory boards identified in RSA 318-B:35, I(b)(2), relevant information to
be used by the regulatory board for further investigation:
(1) When there
is cause to believe a potential violation of law or a breach of professional
standards may have occurred; and
(2) When there
is cause to believe that a failure to report the dispensing of a schedule II–IV
controlled substance conceals a potential pattern of diversion of controlled
substances into illegal use.
(b) The program shall notify prescribers and
dispensers:
(1) When there
is cause to believe a potential violation of law or a breach of professional
standards may have occurred, unless such notice is likely to interfere with an
investigation conducted by the regulatory board; and
(2) When there
is cause to believe a patient might be obtaining prescriptions in a manner that
may represent misuse or abuse of controlled substances, including obtaining
controlled substances from multiple practitioners or dispensers.
(c) The program vendor shall report to the board
on at least a quarterly basis all the reports made in (a) and (b) above.
(d)
The board may use and release information and reports from the program
for program analysis and evaluation, statistical analysis, public research,
public policy, and educational purposes, provided the data are aggregated or
otherwise de-identified.
Source. #10526, eff 2-26-14;
ss by #12465, eff 1-23-18
CHAPTER Ph 1600 PHARMACY INTERNS
PART Ph 1601 PURPOSE AND SCOPE
Ph 1601.01 Purpose and Scope. The provisions of
this chapter shall apply to, and impose duties upon, all pharmacy interns
holding registrations issued by the board.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1602 DEFINITIONS
Ph
1602.01 Definitions. Except where
the context makes another meaning manifest, the following definitions shall
apply:
(a)
“Registered pharmacy intern” means a person:
(1)
Who is enrolled in a
professional degree program of a school or college of pharmacy that has been
approved by the board and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist;
(2)
Who is a graduate of an
approved professional degree program of a school or college of pharmacy or is a
graduate who has established educational equivalency by obtaining a Foreign
Pharmacy Graduate Examination Committee (FPGEC) certificate, who is currently
licensed by the board of pharmacy for the purpose of obtaining practical
experience as a requirement for licensure as a pharmacist;
(3) Who is a
qualified applicant awaiting examination for licensure or meeting board
requirements for re-licensure; or
(4)
Who is participating in a residency or fellowship, except individuals
that hold an active license to practice pharmacy in the State of New Hampshire.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1603 IDENTIFICATION
Ph
1603.01 Identification. The
pharmacy intern shall be so designated in his or her professional relationships,
and shall in no manner falsely assume, directly or by inference, to be a
pharmacist. The board shall issue to the pharmacy intern a registration for
purposes of identification and verification of his or her role as a pharmacy
intern, which registration shall be surrendered to the board upon
discontinuance of pharmacy practice experiences for any reason including
licensure as a pharmacist. Only individuals properly registered by
the board as a pharmacy intern shall take, use, or exhibit the title of
pharmacy intern, or any other term of similar like or import.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1604 REGISTRATION
Ph
1604.01 Application.
(a) No person shall perform the functions or
duties of a pharmacy intern unless such person is registered by the board.
(b) Application form “Pharmacy Intern Initial
Registration Form” for registration of pharmacy interns in New Hampshire may be
obtained from and shall be filed at the office of the board, identified in Ph
103.03.
(c) Each applicant shall provide the following on
form PI-1:
(1)
Name, gender, current mailing address, and home telephone number;
(2)
Social security number, date of birth, and email address;
(3)
Name and address of the college or university where currently enrolled
in, or graduated from, the pharmacy program;
(4)
Anticipated date of graduation from accredited pharmacy program;
(5)
Record of convictions of violations of federal, state, or local drug or
pharmacy- related laws or regulations;
(6)
An indication as to whether the applicant is or ever has been registered
or licensed as a pharmacy intern in New Hampshire or any other state and, if
so, an indication as to which state(s) and whether such registration or license
is currently valid;
(7)
An indication as to whether the applicant has ever voluntarily
surrendered his or her pharmacy intern registration in this or any other state
or jurisdiction and, if so, an explanation of such surrender; and
(8)
Applicant’s signature and date.
(d) The applicant shall submit with application
form PI-1, the prescribed fee of $25.
(e)
An applicant for registration as a registered pharmacy intern shall meet
the following requirements:
(1)
Be at least 18 years of age;
(2) Be enrolled in or possess a pharmacy
degree from an accredited college or university pharmacy program;
(3)
Be of good moral character,
as demonstrated by the information provided by the applicant on the
registration form and any attachments; and
(4)
Has not been convicted of
a felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule, or regulation.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1605 REGISTRATIONS – CHANGES IN SUPPORTING DATA
Ph
1605.01 Reporting Changes.
(a) The person to whom a pharmacy intern
registration has been issued shall notify the board within 15 days if a change
of one or more of the following occur:
(1)
Name;
(2)
Address;
(3) Transfer of enrollment from accredited
college or university pharmacy program to another; or
(4)
Permanent separation of enrollment from his or her accredited pharmacy
program, not to include graduation.
(b) The notice shall contain the following:
(1)
Name of the registrant;
(2)
Address of the registrant including old and new, if applicable;
(3)
Registrant’s registration number;
(4)
Name of the school of pharmacy attending, including former and current,
if applicable;
(5)
Graduation date or anticipated date of graduation from accredited
pharmacy program;
(6)
Certification status, if applicable; and
(7)
All new violations of law, convictions, fines, discipline or any
registration, certification or license revocations for violation of
pharmacy-related drug laws or regulations in this or any other state.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1606 PHARMACY INTERNS – STANDARDS OF PRACTICE
Ph
1606.01 Responsibilities and Duties.
(a)
The pharmacist-in-charge shall identify pharmacy interns and assure that such
persons are registered with the board as pharmacy interns prior to employment
or experiential pharmacy rotation.
(b)
All pharmacy interns shall wear a name tag, identifying them as a
“Pharmacy Intern” while on duty.
(c) The pharmacist-in-charge shall determine the duties of each pharmacy
intern based upon the needs of the pharmacy and
experiential site.
(d) A pharmacy intern shall be allowed to engage
in all activities in the practice of pharmacy provided that such activities are
under the supervision of a pharmacist with the one exception of product
verification.
(e) A pharmacist shall be in contact with, and actually
giving instructions to, the pharmacy intern during all professional activities.
(f) Only pharmacy interns in their last professional year or graduates of an
approved professional degree program of a school or college of pharmacy or
graduates of an approved professional degree program of a school or college of
pharmacy or graduates who have established educational equivalency by obtaining
a Foreign Graduate Examination Committee (FPGEC) certificate may perform
product verification. Direct supervision
shall not be required for product verification.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1607 REVOCATION AND DENIAL
Ph
1607.01 Effect of Revocation and
Denial.
(a) The board shall refuse to issue a registration,
or after notice and hearing, shall revoke a registration whenever the board
finds by the preponderance of the evidence any of the following:
(1)
That the applicant, or registrant, has willfully violated any of the
provisions of RSA 318 or Ph 1600;
(2) That the applicant has been convicted
of a felony or a misdemeanor resulting from a violation of any federal, state,
or local drug or pharmacy-related law, rule, or regulation;
(3) That the applicant has attempted to
obtain a pharmacy intern registration by fraudulent means;
(4)
That the applicant is unable to engage in the performance of pharmacy
intern functions with reasonable skill and safety by reason of illness,
inebriation, misuse of drugs, narcotics, alcohol, chemicals or any other
substance, or as a result of any mental or physical condition;
(5)
The suspension, revocation, or probation by another state of the
applicant’s license, permit, or registration to practice as a pharmacy intern;
(6)
That the applicant refused to appear before the board after having been
ordered to do so in writing; or
(7)
That the applicant made any fraudulent or untrue statement to the board.
(b) The pharmacist-in-charge or other staff
pharmacist shall notify the board, in writing, within 7 calendar days after
becoming aware that a pharmacy intern has adulterated, abused, stolen, or
diverted drugs.
(c) The board shall reinstate a registration
after review, provided that the reason for revocation no longer exists, or it
is determined that there is no longer a threat to public safety.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
PART Ph 1608 RENEWAL OF REGISTRATIONS
Ph
1608.01 Renewal Registrations
Required. All pharmacy intern registrations shall expire annually on
September 30.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
Ph 1608.02 Renewal Application Where Obtained and
Filed. Applications for the renewal
of a registration for a pharmacy intern shall be filed online at
https://nhlicenses.nh.gov/eGov/Login.aspx.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
Ph 1608.03 Renewal
Application Contents and When Filed.
Renewal applications shall be filed with the board in accordance with
the following:
(a)
Applications for renewal of pharmacy intern registration shall be made online
at https://nhlicenses.nh.gov/eGov/Login.aspx.
(b) Each applicant shall provide the following
information online as part of his or her renewal:
(1)
Original registration number;
(2)
Name, current mailing address, and home telephone number;
(3)
Social security number, date of birth, and email address;
(4)
Name and address of the college or university where currently enrolled
in, or graduated from, the pharmacy program;
(6)
Record of convictions of
violations of federal, state, or local drug or pharmacy-related laws or
regulations;
(7)
Applicant’s signature and date; and
(8)
Employment name, address, phone number, and the name of the supervisor
and pharmacist-in-charge;
(c)
The application and the prescribed fee of $25 shall be filed with the
board no later than September 30.
Source. #10721, eff
11-22-14; ss by #12670, eff 11-17-18
Ph 1608.04 Reinstatement.
(a) A registered intern’s failure
to renew his or her registration by September 30 shall result in a lapsed
registration.
(b) Any intern that wishes
to reinstate a lapsed license shall do so by completing and submitting an
“Intern Reinstatement Application”, effective October 2018 and available on the
board’s website at www.oplc.nh.gov/pharmacy.
(c) A reinstatement
applicant shall also submit a dated and signed letter explaining why he or she
allowed his or her registration to lapse and an indication as to whether he or
she practiced as a pharmacy intern with a lapsed registration.
Source. #12670, eff 11-17-18
CHAPTER Ph 1700
CONTINUOUS QUALITY IMPROVEMENT
PART Ph 1701
PURPOSE AND SCOPE
Ph
1701.01 Purpose. The purpose of this chapter is to require
that a pharmacy permit holder establish and manage a continuous quality
improvement program in each pharmacy licensed
by the permit holder. Said continuous quality
improvement program is to assess errors that occur during the review,
preparation, dispensing or administration of medications by pharmacy staff, and
to ensure appropriate action is taken to prevent or reduce the likelihood of a
recurrence of identified errors.
Programs established pursuant to this section are for public safety, and
shall be non-punitive and seek to identify improvements that can be made in
processes, systems, technology, or training in order to make appropriate
changes to improve them.
Source. #12758, eff
4-19-19
Ph 1701.02 Scope. This chapter shall apply to all pharmacies licensed by the
board of pharmacy.
Source. #12758, eff
4-19-19
PART Ph 1702
DEFINITIONS
Ph
1702.01 Definitions. In this section the following definitions
apply:
(a) “Continuous quality improvement (CQI)” means
a system of standards and procedures to identify and
evaluate quality-related events to improve patient care;
(b) “Continuous quality improvement (CQI)
program” means a planned process to record and assess quality related events
that includes a procedure for documenting actions to improve the quality of
patient care, and maintenance of a summary of the documented actions;
(c) “Quality-related event” means an error,
adverse incident, near miss, or unsafe condition that occurs in the review,
preparation, dispensing or administration of medications by pharmacy staff; and
(d)
“Patient Safety Organization” means an entity that has the same meaning
as the term used in the Patient Safety and Quality Improvement Act of 2005, 42
U.S.C section 299b-21(7), a private or public entity or component thereof that
is listed by the Secretary of Health and Human Services pursuant to 42 U.S.C.
section 299b-24(d).
Source. #12758, eff
4-19-19
PART Ph 1703
PROGRAM REQUIREMENTS
Ph 1703.01 General Requirements
(a) A pharmacy shall either submit quality-related
events to a patient safety organization (PSO) or shall create and maintain an
internal program that captures and analyzes quality-related events that comply
with this chapter.
(b) Licensed pharmacies shall ensure that all
reasonably necessary steps have been taken to prevent or minimize patient harm following any quality-related event that reaches a patient.
(c) The permit holder of the pharmacy shall
maintain within the pharmacy a current written policy and procedures manual
that clearly states the organization philosophy and goals for a continuous
quality improvement (CQI) program, delineate the parameters in which the
organization interacts with its employees related to such a program, and
provides a sound framework for operating and maintaining such a program.
(d) Said current policy and procedures manual shall include at least the
following:
(1) Purpose of the program;
(2) Definitions used in the program;
(3) Policy on how to report a quality-related
event;
(4) Policy for
program meetings including frequency of meetings, staff to attend, and
involvement of either the pharmacist-in-charge or consultant pharmacist;
(5) Policy for maintaining program integrity and
confidentiality of information;
(6) Policy for staff education and ongoing
training of employees related to CQI program;
(7) Policy for
employee engagement and communication of changes made related to the program;
and
(8) Policy for maintaining summarization
documents for board inspection.
Source. #12758, eff
4-19-19
PART
Ph 1704 CONFIDENTIALITY OF
QUALITY-RELATED EVENT REPORTS
Ph 1704.01 Availability
of Quality-Related Event Reports.
All quality-related events and quality-related reports that are reported
to a PSO shall be deemed by the board to be confidential and privileged patient
safety work product under the
Patient Safety and Quality Improvement Act of 2005 and shall not be required to
be made available for inspection by or reported to the board. Quality-related events and quality-related
event reports that are not reported to a PSO shall be considered confidential
peer review documents not subject to discovery in civil litigation or
administrative actions.
Source. #12758, eff
4-19-19
PART
Ph 1705 CONTINUOUS QUALITY IMPROVEMENT
MEETINGS
Ph 1705.01 Requirements for Continuous Quality Improvement Meetings.
(a) A pharmacy shall hold a continuous quality
improvement (CQI) meeting at least once every 3 months.
(b) The pharmacist-in-charge or consultant
pharmacist for the licensed pharmacy, or their designee, shall attend each
meeting.
Source. #12758, eff
4-19-19
PART Ph 1706
SUMMARIZATION DOCUMENT
Ph 1706.01 Requirements
for the Summarization Document.
(a) A summarization document shall be created
after each CQI meeting and shall be retained onsite within the licensed
pharmacy for a minimum of 4 years and made available within 3 business days
upon request by the board.
(b) The summarization document shall not contain
identifiable patient information, or information that would identify
individuals involved in a quality-related event, or any information that can be
used to identify the quality-related event.
(c) The summarization document shall include, at
a minimum, the following information:
(1) A list of all individuals in attendance at the
meeting; and
(2) A summary of steps or actions taken since the last
meeting intended to improve processes, systems, technology or training related
to the review, preparation, dispensing, or administration of medications.
Source. #12758, eff
4-19-19
PART
Ph 1800 - 1900
– RESERVED
CHAPTER Ph 2000 LICENSING OF OUTSOURCING FACILITIES
IDENTIFIED AS 503B FACILTIES BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
PART Ph 2001 PURPOSE AND SCOPE
Ph
2001.01 Purpose. The purpose of these provisions is to regulate
the licensing of outsourcing facilities, as defined and registered by the Food
and Drug Administration pursuant to section 503B of the Federal Food, Drug and
Cosmetic Act, codified as 21 USC 353b.
Source. #12336, eff 7-22-17
PART Ph 2002 DEFINITIONS
Ph
2002.01 Statutory Definitions Adopted. All terms used in these rules shall have the
same meaning as in RSA 318:1, RSA 318-B:1, and RSA 541-A:1.
Source. #12336, eff 7-22-17
Ph
2002.02 Other Definitions.
(a) “Outsourcing facility” means “outsourcing
facility” as defined in RSA 318:1, XXX, namely, “a facility at one geographic
location or address that is engaged in the compounding of sterile drugs, has
elected to register as an outsourcing facility, and complies with all of the
requirements of section 503B of the Federal Food, Drug, and Cosmetic Act.”
Source. #12336, eff 7-22-17
PART Ph 2003 STANDARDS OF PRACTICE FOR OUTSOURCING
FACILITIES
Ph
2003.01 Standards of Practice and
Requirements for Outsourcing Facilities.
(a) Outsourcing facilities shall maintain a human
drug compounding outsourcing facility registration from the United States Food
and Drug Administration (FDA) when compounding or manufacturing drugs for sale
in New Hampshire.
(b) Outsourcing facilities shall be in compliance
with applicable United States Drug Enforcement Administration (DEA)
regulations.
(c)
Outsourcing facilities shall be required to test all lots or batches of
finished drug products compounded from bulk active pharmaceutical ingredients
(API) to determine whether they meet final product specifications for
sterility, endotoxin, and potency before their release for distribution. No products shall be released for use until
this testing is conducted and the results confirm that the finished drug
product meets specifications. Copies of the test results shall be readily
available and included with each batch sent to New Hampshire customers and
available for inspection by the pharmacy board.
(d) Outsourcing facilities compounding drug products
from sterile, commercially available raw materials shall be required to test
all lots or batches of finished drug products to determine whether they meet
final product specifications for sterility, endotoxin, and potency before their
release for distribution. No products
shall be released for use until this testing is conducted and the results
confirm that the finished drug product meets specifications. Copies of the test results shall be readily
available for each batch sent to New Hampshire customers and available for
inspection.
(e) All facilities at which sterile drugs are
compounded shall provide storage areas that ensure adequate lighting,
ventilation, temperature, sanitation, humidity, equipment, and security
conditions. All sterile compounded
products shall be stored at appropriate temperatures per label requirements or
in compliance with the latest edition of the official United States
Pharmacopeia (USP) compendium requirements to help ensure that the identity,
strength, quality, and purity of the products are not affected. If no temperature requirements are listed,
compounded products may be stored at room temperature. A separate storage section shall be provided
for compounded products that are deteriorated, outdated, misbranded, or
otherwise adulterated.
(f) All buildings at which sterile drugs are
compounded shall be of a size, construction, and location that facilitates
cleaning and maintenance. The buildings
shall meet all applicable federal, state, and local standards. A facility shall not be located in a
residence. All facilities shall be
located in an area that is commercially zoned.
(g) Each outsourcing facility shall be equipped
with an internal alarm system to detect entry after hours. The alarm system shall be of the type that
transmits a signal directly to a central station protection company, to a local
or state police agency that has a legal duty to respond, or to a 24-hour
control station operated by the outsourcing facility.
(h) Outsourcing facilities shall ensure that all
access from outside their premises is secure.
This shall include, but not be limited to, the installation of adequate
lighting at the outside perimeter of the premises that deters unauthorized
entry into the premises.
(i) Internal security policies shall be developed
by the outsourcing facility to provide protection against theft by personnel.
(j) No outsourcing facility shall distribute
sterile compounded drugs directly to a consumer or a patient, or operate in
such a manner as to endanger the public health.
(k) Any person who compounds sterile drugs in
violation of RSA 318:51-d or the provisions of Ph 2000 shall be subject to
disciplinary action as provided in RSA 318:29.
Source. #12336, eff 7-22-17
Ph
2003.02 License Required.
(a) No person shall compound legend drugs or
controlled drugs, as defined in RSA 318-B:1, VI, and no person acting as or
employed by an outsourcing facility shall supply such drugs, without first
having obtained a license from the board.
No license shall be issued or renewed for an outsourcing facility unless
the same shall be operated in a manner prescribed by law and according to Ph
2000. The license shall expire
biennially on June 30 of each odd-numbered year. The license shall not be transferable.
(b) Separate licenses shall be required for each
compounding site owned or operated by an outsourcing facility. Provided, however, that an agent or employee
of any licensed outsourcing facility shall not be required to be licensed under
this section and may lawfully possess sterile compounded products if he or she
is acting in the usual course of his or her business or employment.
(c) Renewal applications shall be filed no later
than June 15th of every odd-numbered year and may be obtained from
the board office. Alternatively, renewal
applications may be filed online at https://nhlicenses.nh.gov/eGov/Login.aspx .
(d) The prescribed fee for original and biennial
renewal licenses for outsourcing facilities shall be $500.00.
Source. #12336, eff 7-22-17; ss by #13117, eff 10-15-20
Ph
2003.03 Obtaining and Filing a
License Application.
(a) An “Application for Pemit – Bulk Sterile
& Non-Sterile Compounders (Including FDA Registered 503B Outsourcing
Facilities)”, form Ph OF-1, revised June 2017, for a permit to license FDA
registered 503B outsourcing facilities in New Hampshire may be obtained from
the board or board website;
(b) Form Ph OF-1 shall be used for:
(1) Applying for a permit to license a 503B
outsourcing facility;
(2) Changing the location of a currently licensed
503B outsourcing facility; and
(3) Changing the ownership of a currently
licensed 503B outsourcing facility.
(c) Form Ph OF-1 shall be filed at the board
office as identified in Ph 103.03.
Source. #12336, eff 7-22-17
Ph
2003.04 Application Contents.
(a) The applicant for a license to operate an
outsourcing facility in New Hampshire shall complete and file the form
described in Ph 2003.03.
(b) The applicant shall indicate his or her
title, and sign and date the application form under the following affirmation:
“I affirm that I am the person authorized
to sign this application for licensure and affirm that this application
(including any accompanying documents) has been examined by me and to the best
of my knowledge and belief is a true, correct and complete application, and if
the registration herein applied for is granted, I hereby agree to and do submit
to the jurisdiction of the New Hampshire Board of Pharmacy and to the laws and
rules of this State. I understand that
as an outsource facility I am required to comply with current Good
Manufacturing Practice (cGMP) standards.
I have read and understand the testing requirements required for shipping
compounded products into New Hampshire.”
(c) The applicant shall submit the following
documents with the application form:
(1)
If shipping controlled drugs, a copy of the facility’s current DEA
registration;
(2)
If licensed by the applicant’s home state, a copy of the current
license; and
(3)
If applicable, a copy of the most recent inspection report from the
applicant’s home state; and
(4)
If applicable, a copy of:
a.
The most recent FDA inspection report;
b.
The FDA issued Form 483; and
c.
The applicant’s response to the Form 483.
(d) The applicant shall submit scale drawings of
the facility, detailing usage of all space.
(e) The applicant shall supplement the
application with any certificates, affidavits, plans, documents, or other
information sufficient to show full compliance with all of the requirements for
licensure.
(f) If the applicant is a corporation, or if the
outsourcing facility will be operated under a corporate name, the applicant
shall submit a certificate from the secretary of state attesting to the
documents creating the corporate person and any amendment(s) thereof to the
certificate of incorporation, or authorizing it to do business in the State of
New Hampshire under the corporate name.
(g) The application shall be filed with the
prescribed fee of $500.00.
Source. #12336, eff 7-22-17;
ss by #13117, eff 10-15-20
Ph
2003.05 Additional Requirements. In addition to the requirements imposed by Ph
2003.04, an applicant for an outsourcing facility license shall demonstrate
that he or she is of good moral character or, if the applicant is an
association or corporation, that the managing officers are of good moral
character, as evidenced by the absence, within the last 5 years, of conviction
of any felony, or of a misdemeanor resulting from a violation of any drug
related law of the United States or of any state.
Source. #12336, eff 7-22-17
Ph
2003.06 Issuance, Denial and
Revocation of License.
(a) If an applicant files an application,
complete in all respects and demonstrates fulfillment of all requirements of
these rules and RSA 318, the board shall issue a license which shall authorize
the operation of an outsourcing facility in the location, and only under the
name specified in the license.
(b) After consideration of the application, the
board shall notify the applicant in writing of all deficiencies in the
application which, in the absence of correction, shall result in the denial of
the application. The applicant shall, within 20 days of the date of the notice
of deficiency, deliver to the board either documents evidencing the correction
of those deficiencies, or a written request for an appeal before the board. In
the absence of a timely filing of either documentation or a request for an
appeal, the application shall, without further action or notice by the board,
be denied effective as of the expiration of 20 days after the date of the
notification of deficiency.
(c) The revocation of an outsourcing facility
license shall permanently withdraw the authority to supply compounded sterile
products in New Hampshire unless a subsequent license is issued pursuant to (d)
below.
(d) A subsequent license may be obtained only by:
(1) Complying with all the
requirements of RSA 318 and these rules regarding the original licensing of
outsourcing facilities;
(2) Paying all penalties assessed
in connection with the cause for revocation; and
(3) By demonstrating that
the cause for revocation does not exist at the time of the subsequent
application.
Source. #12336, eff 7-22-17
PART Ph 2004 NOTIFICATION REQUIREMENTS
Ph
2004.01 Reporting Changes. The person to whom a license to operate a
503B outsourcing facility has been issued in New Hampshire shall, within 30
days of that person's discovery of a change in any of the data contained in the
application for an original or renewal permit, report that change to the board
in writing. An original new permit application, “Application for Pemit – Bulk
Sterile & Non-Sterile Compounders (Including FDA Registered 503B
Outsourcing Facilities)”, form Ph OF-1, revised June 2017, shall be completed
and filed in addition to the written notice when the name, location, ownership,
or licensed area are changed.
Source. #12336, eff 7-22-17
Ph
2004.02 Notice of Disciplinary Action. An outsourcing facility licensed under these
rules shall, within 30 days of any written warnings or disciplinary action from
any state or federal licensing or enforcement agency, notify the board and
provide a copy of the action to the board office, identified in Ph 103.03.
Source. #12336, eff 7-22-17
PART Ph 2005 RENEWAL LICENSES
Ph
2005.01 Renewal Permits
Required. The person to whom a
license to operate a 503B outsourcing facility has been issued shall renew that
license by June 15th of every odd-numbered year.
Source. #12336, eff 7-22-17;
ss by #13117, eff 10-15-20
Ph 2005.02 Renewal Application Where Obtained and
Filed.
(a) Applications for the renewal of a license to
operate a 503B outsourcing facility, “Renewal – Bulk Sterile & Non-Sterile
Compounders (Including FDA Registered 503B Outsourcing Facilities)”, form Ph
OF-2, revised June 2017, may be obtained from the board’s website at
www.oplc.nh.gov/pharmacy, and shall be filed at, the board office. Alternatively, renewal applications may be filed online at https://nhlicenses.nh.gov/eGov/Login.aspx
(b) The applicant shall indicate his or her
title, and sign and date the application form under the following affirmation:
“I affirm that I am the person authorized to sign this application
for licensure and affirm that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the registration herein
applied for is granted, I hereby agree to and do submit to the jurisdiction of
the New Hampshire Board of Pharmacy and to the laws and rules of this State. I
understand that as an outsource facility I am required to comply with current
Good Manufacturing Practice (cGMP) standards.
I have read and understand the testing requirements required for
shipping compounded products into New Hampshire.”
(c) The applicant shall submit the following
documents with the application form:
(1) If shipping controlled
drugs, a copy of the facility’s current DEA registration;
(2) If licensed by the
applicant’s home state, a copy of the current license; and
(3) I f applicable, a copy of the most recent inspection report
from the applicant’s home state; and
(4) If applicable, a copy
of:
a. The most recent FDA
inspection report;
b. The FDA issued Form 483;
and
c. The applicant’s response
to the Form 483.
Source. #12336, eff 7-22-17;
ss by #13117, eff 10-15-20
Ph
2005.03 Renewal Application Contents
and When Filed.
(a) Applications for renewal of a license to
operate a 503B outsourcing facility shall consist of a completed renewal
application form as described in Ph 2005.02 and the prescribed fee of $500.00.
(b) Renewal applications as required pursuant to
Ph 2005.01 shall be submitted to the board no later than the 15th
day of June of every odd-numbered year.
Source. #12336, eff 7-22-17;
ss by #13117, eff 10-15-20
Ph
2005.04 Renewal Application Deficiencies. The board shall notify the applicant in
writing as to whom the application for renewal is deficient. The applicant may,
within 10 days after the date of the notice of deficiency, correct the
deficiency or file with the board a written request for an appeal.
Source. #12336, eff 7-22-17
Ph
2005.05 Issuance and Denial of
Renewal License.
(a) If an applicant shall timely file an
application, complete in all respects, that demonstrates the fulfillment of all
the requirements of these rules and RSA 318, the board shall issue a renewal
permit.
(b) An application which continues to fail to
meet the requirements of these rules and RSA 318 shall, after the notice and
opportunity for a hearing, be denied.
Source. #12336, eff 7-22-17
PART Ph 2006 POLICIES, PROCEDURES AND RECORDKEEPING
Ph
2006.01 Written Policies and
Procedures.
(a) Written policies and procedures shall be
developed by management personnel to assure that the outsourcing facility
prepares for, protects against, and handles crises situations that affect the
security or operation of the facility. Such crises shall include fires, floods,
or other natural disasters, and situations of local, state or national
emergency.
(b) Written policies and procedures described in
(a) above shall also provide for:
(1)
The management and correction of all errors or inaccuracies in
inventories;
(2)
The assurance that any outdated stock, or any stock with an expiration
date that, in the outsourcing facility’s view, does not allow sufficient time
for repacking or resale, shall be prepared for return to the outsourcing
facility or otherwise destroyed; and
(3)
The control over the shipping and receiving of all stock within the
operation.
(c) A copy of the policies and procedures, or
sections thereof, shall be made available to the board upon request.
Source. #12336, eff 7-22-17
Ph
2006.02 Responsibility for Operation. An outsourcing facility shall maintain a list
of principals and persons in charge including officers, directors, or primary
stockholders and their qualifications.
Source. #12336, eff 7-22-17
Ph
2006.03 Returned Goods. An outsourcing facility shall maintain a
procedure for the handling and disposal of returned goods.
Source. #12336, eff 7-22-17
Ph
2006.04 Handling Recalls.
(a) An outsourcing facility shall maintain a
written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover
all recalls and withdrawals of compounded sterile products due to:
(1)
A voluntary action on the part of the compounder;
(2)
The direction of the Food and Drug Administration, or any other federal,
state or local governmental agency; and
(3)
Replacement of existing merchandise with an improved product or new
design.
Source. #12336, eff 7-22-17
Ph
2006.05 Recordkeeping.
(a)
The requirements of Ph 2006.05 shall be in addition to all record keeping and
reporting requirements contained in all federal regulations and state rules.
(b)
Inventories and other records of transactions regarding the receipt and
disposition of sterile compounded products shall be maintained and made
available for inspection by the board’s inspectors for a period of 2 years.
(c) Records may be kept at a central location
rather than at each outsourcing facility, but records shall be made available
for inspection within 72 hours of request by the board’s inspectors.
Source. #12336, eff 7-22-17
Ph
2006.06 Inspections.
(a) Outsourcing facilities shall be subject to
inspections by the FDA on a risk-based schedule.
(b) Information that is considered to contain
trade secrets or which might be proprietary in nature shall be protected from
public disclosure.
Source. #12336, eff 7-22-17
PART Ph 2007 DISPENSING AND DISTRIBUTION REQUIREMENTS
Ph
2007.01 Dispensing and Distribution
Requirements. Compounded sterile drugs
shall be dispensed in accordance with Ph 704.
Source. #12336, eff 7-22-17
PART Ph 2008 LEGAL REQUIREMENTS
Ph
2008.01 Compliance with State and
Federal Law.
(a) All outsourcing facilities licensed under
this chapter shall comply with all applicable state and federal laws, rules,
and regulations.
(b) All outsourcing facilities licensed and doing
business in New Hampshire, shall, before shipping or distributing any
compounded sterile drugs, verify that the recipient is properly licensed to
receive and possess such drugs.
(c) All outsourcing facilities licensed and doing
business in New Hampshire shall not provide unsolicited compounded sterile drug
samples to licensed practitioners.
(d) Except as provided in (c) above, a duly
authorized agent of an outsourcing facility licensed and doing business in New
Hampshire, may possess and distribute compounded sterile drugs to individuals
who may lawfully possess such drugs as may be necessary to further the licensed
activity of the outsourcing facility.
Source. #12336, eff 7-22-17
CHAPTER Ph 2100
INSPECTIONS
PART Ph 2101
AUTHORITY AND SCOPE
Ph
2101.01 Board Authority for Inspections. All inspections shall be conducted as stated
in Ph 2104, as part of an investigation process, and at the request of the
various regulatory boards listed in RSA 318:8-a and RSA 318:9-a.
Source. #13028, eff 4-11-20
Ph
2101.02 Scope. Registrants and licensees, including all
pharmacists, pharmacies, and practitioners pursuant to RSA 318:8-a and RSA
318:9-a, shall permit the board investigators, board inspectors, and board
commissioners to enter and inspect the premises and audit the records and
operations for compliance with the statutes and rules enforced by or under the
board’s jurisdiction.
Source. #13028, eff 4-11-20
PART Ph 2102
DEFINITIONS
Ph
2102.01 Definitions. In addition to the definitions in RSA 318:1,
the following definitions shall apply to this chapter:
(a)
“Clinics” means an institution, building, or part of a building devoted
to the diagnosis and care of outpatient ambulatory patients. The term also
includes public health
clinics and methadone clinics;
(b) “Compounding pharmacy” means a pharmacy
licensed to perform the preparation, mixing, assembling, packaging or labeling of a drug
or device as a result of a practitioner's prescription drug order;
(c) “Facility” means any pharmacy, hospital,
medical clinic, practitioner office, methadone clinic, or veterinarian
clinic that has prescription drugs on its premises and is inspected by the
pharmacy board;
(d) “High risk compounding” means compounding that
requires the use of non-sterile ingredients or non-sterile devices, which
usually creates a high-risk condition. Exposing sterile ingredients and devices
to air quality below ISO Class 5, an International Organization for
Standardization metric for environmental management, will create a high-risk
compounding situation, as will the prolonged storage of opened or partially-used
products that lack antimicrobial preservatives in an environment in less than
ISO Class 5 conditions;
(e) “In-patient institution” means a facility where a patient is formally admitted or hospitalized for
treatment or care and stays for a minimum of one night in the hospital or other
institution providing in-patient care;
(f) “Inspector” means a pharmacist or certified
pharmacy technician employed by the pharmacy board to inspect
facilities, to ensure that they comply with federal and state law and the rules
established by the board;
(g) “Institution” means an “institution” as
defined in Ph 701.02(h), namely a health care facility which provides inpatient
care and includes:
(1) Hospitals;
(2) Nursing
homes;
(3) Extended
care facilities;
(4) Residential
care facilities;
(5)
Infirmaries; and
(6)
Correctional facilities.
(h) “Institutional pharmacy” means an “institutional
pharmacy” as defined in Ph 701.02(i), namely “an area in an
institution where drugs are stored, manufactured, compounded, dispensed, or
issued to other areas or departments of the institution;”
(i) “Investigator” means a pharmacist employed by
the pharmacy board to investigate consumer complaints of pharmacy law or rule
violations by a person licensed at the time the alleged violation occurred;
(j)
“Licensee” means any person or entity which is licensed, certified,
registered, or regulated by the pharmacy board or a board listed in RSA 318:8-a
and RSA 318:9-a;
(k) “Limited retail drug distributor” means a distributor of
prescription devices or medical gases delivered directly to the consumer pursuant
to a practitioner's prescription order, or federally funded clinics operated
under contract with the department of health and human services and drug abuse
treatment centers, where legend and controlled drugs are held, stored, or
dispensed to patients pursuant to the order of an authorized practitioner;
(l)
"Limited retail drug distributor'' means a distributor of legend
devices or medical gases delivered directly to the consumer pursuant to a
practitioner's prescription order, or federally funded clinics operated under
contract with the department of health and human services and drug abuse
treatment centers, where legend and controlled drugs are held, stored, or
dispensed to patients pursuant to the order of an authorized practitioner;
(m)
“Methadone clinic” is a clinic which has been established for the
dispensing of methadone and other medications to treat opioid addiction. In the
United States, by law, patients must receive methadone under the supervision of
a physician, and dispensed through an opioid treatment program certified by
Substance Abuse and Mental Health Services Administration and registered with
the Drug Enforcement Agency;
(n) “Practitioner” means any person who is
lawfully entitled to prescribe, administer, dispense or distribute prescription
drugs to patients;
(o) ”Public health clinics”, are
private, nonprofit organizations that directly or indirectly, through contracts
and cooperative agreements, provide primary health services and related
services to residents of a defined geographic area that is medically
underserved. The term includes
“community health centers (CHCs); and
(p) “Retail pharmacy” means a pharmacy that
dispenses and sells prescription drugs to patients with a valid prescription in
an outpatient setting at retail prices.
Source. #13028, eff 4-11-20
PART Ph 2103 PRE-INSPECTION REQUIREMENTS
Ph 2103.01 Licensee Pre-Inspection Duties for
Pharmacies.
(a)
All pharmacies shall be mailed, one to 3 months prior to inspection, a
“Pre-Inspection Checklist” advising the pharmacist-in-charge or
designated representative that the items listed in (b) below must be readily
available to pharmacy board inspectors at the beginning of the inspection.
(b)
The following items must be available to board inspectors at the
beginning of the inspection:
(1) A printed list of the
facility’s hours of operation;
(2) The average daily and weekly volume of prescriptions processed;
(3) The e-mail address of the pharmacist in charge or designated
representative;
(4) A list of all pharmacists
employed at the pharmacy, with license number, if applicable;
(5) A list of all certified
pharmacy technicians employed at the pharmacy with registration number, if
applicable;
(6) A list of all registered pharmacy technicians
employed at the pharmacy with registration number, if applicable;
(7) A list of current pharmacy technician training data for technicians in
certification training program, if applicable;
(8) Date of most recent alarm
test;
(9) Policy for dispensing Narcan/naloxone
(10) Copy of pharmacy’s break
policy, if applicable;
(11) Break counseling log book, if applicable;
(12) Drug
recall file;
(13)
Documentation of patient counseling, if applicable;
(14) Protocol
for vaccines;
(15) Evidence
of up to date pharmacist CPR certification, if applicable;
(16) Pharmacist
vaccination training information, if applicable;
(17)
Collaborative practice agreements, if applicable; and
(18) Quality
assurance information as stated in Ph 1700, if applicable;
(c)
Pharmacies involved in sterile and non-sterile compounding shall have
available for pharmacy board review a copy of their scheduled outsourced
environmental monitoring report as required by Ph 405.05 relative to sterile
quality requirements.
(d) Pharmacies shall make available all
environmental monitoring reports upon request.
Source. #13028, eff 4-11-20
PART Ph 2104 INSPECTION
FREQUENCY
Ph 2104.01 Scheduling. Inspections shall be:
(a)
For any facility involved in sterile compounding, scheduled up to one
month in advance;
(b)
Unannounced for any other facility, notwithstanding the pre-inspection
checklists sent to licensees in the quarter in which their inspection shall
take place;
(c)
Conducted upon the presentation of appropriate identification; and
(d)
Investigators/inspectors shall present a “Notice of Inspection” form
(#Ph510) upon arrival detailing the purpose of the inspection to the person of
record on the day of the inspection. The
form shall be signed underneath the following certification statement:
This is to acknowledge that NH Board of Pharmacy
Inspector/Investigator, ____________ has identified him/her self by
presentation of official credentials pursuant to the provisions of NH RSA
318:8, RSA 318:8-a of the NH Pharmacy Act and RSA 318-B:25 of the NH Controlled
Drug Act, and I hereby grant permission for the aforementioned Board agent to
inspect any and all of the records relative to the receipt, distribution and security
of prescription/legend drugs at this location. This also includes records which
are required per the provisions of 21 CFR 1300 to end, of the Federal
Controlled Substances Act. This inspection also addresses any other standards
of practice issues outlined by other health care agencies, which these agents
are charged to enforce. By my signature below, I hereby acknowledge the receipt
of this Notice of Inspection and certify that:
1. I am the (title)
_____________________________________, for the above described location;
2. I have read this Notice of Inspection and
understand its contents and purpose;
3. I have the authority to act in this matter
and have signed this Notice of Inspection pursuant to my authority;
4. I have been provided with the purpose of this
Notice of Inspection as noted above, but fully realize that thescope of this
inspection may encompass ALL of the records required pursuant to the above
mentioned State/Federal Statutes and Rules/Regulations; and
5. I have voluntarily consented to this
inspection.
Source. #13028, eff 4-11-20
Ph 2104.02 Inspection Timeframes.
(a)
Unless otherwise specified in this chapter, pharmacy board inspections
shall be conducted at a minimum:
(1) Annually for:
a.
Retail pharmacies;
b.
Institutional pharmacies;
c.
Compounding pharmacies;
d.
Public health clinics; and
e. Methadone
clinics.;
(2) Every 3 years for:
a.
Veterinarians and veterinary clinics without controlled substances;
b.
Drug manufacturers;
c.
Drug wholesalers;
d.
Limited retail drug distributors; and
e. Naturopaths
without controlled substances.
(3) Every 5 years for:
a.
Practitioners in private practice without controlled substances; and
b.
Medical and hospital clinic-based practitioner without controlled
substances.
(b)
The following entities possessing controlled substances shall be
inspected at a minimum every 2 years;
(1) Practitioners in private practice;
(2) Clinic-based practitioners;
(3) Veterinarians or veterinary
clinics; and
(4) Naturopaths.
Source. #13028, eff 4-11-20
PART Ph 2105 RISK LEVEL
INSPECTIONS
Ph 2105.01 Risk Level Assignment.
(a)
Pharmacy inspections shall be conducted based on risk level as assigned
by pharmacy board staff.
(b)
Risk level shall be assigned by the pharmacy board compliance staff
following inspection and shall be reevaluated on a yearly basis or upon:
(1) A review of
previous inspections;
(2) A review of
minor violations if applicable;
(3) A review of
control loss information;
(4) A major
violation as set forward in this chapter; or
(5)
Investigatory discipline as set forward in Ph 2200.
(c)
A pharmacy’s prescription volume level shall be evaluated by the
pharmacy board compliance staff and assigned as:
(1) Low, for a
prescription volume of less than 1,250 prescriptions per week;
(2) Medium, for
a prescription volume of 1,250 or more and less than 2,000 prescriptions per
week; and
(3) High, for a
prescription volume of 2,000 or more prescriptions per week.
(d)
Risk level assignments and inspections, in addition to the
self-inspection requirements in Ph 2106, shall be as follows:
(1) For low risk inspections:
a.
Pharmacy board inspections shall occur biennially; and
b.
Low risk facilities shall include:
1. Retail pharmacies with a proven record of
compliance for a period of 3 years;
2. Facilities with a low to medium prescription
volume; and
3. Facilities with a pharmacist-in-charge with
no violations in the previous 2 years and previous satisfactory inspection and
stability of at least 2 years at the site;
(2) For medium risk inspections:
a.
Board inspections shall occur annually; and
b. Medium
risk facilities shall include:
1. Institution pharmacies not involved in
sterile or non-sterile compounding;
2. In-patient institutions involved in sterile
or non-sterile compounding as defined by United States Pharmacopeia Chapter 797
(USP 797);
3. High prescription volume pharmacies with a
pharmacist-in-charge stability of at least 2 years at site as identified by
pharmacy board staff;
4. Pharmacies with 6 minor violations or
warnings, such as for temperature variations of refrigerated storage;
5. Non-sterile compounding pharmacies; and
6. Outpatient pharmacies involved in low to
medium risk compounding as defined by USP 797; and
(3) For high risk inspections:
a.
Pharmacy board inspections shall occur up to 2 times a year; and
b.
High risk facilities shall include:
1. Outpatient pharmacies involved in high risk sterile
and complex nonsterile compounding as defined by USP 797;
2. Retail pharmacies with any previous violation
of federal law, including previous cases of drug diversion, or a record of
non-compliance with state law or administrative rule by pharmacy staff or
permit holders over a 3-year period;
3. Pharmacies with a pharmacist-in-charge change
3 or more times in one calendar year;
4. Pharmacies with any unresolved control drug
loss forms pursuant to Ph 700; and
5. Practitioners,
clinics, veterinarians, veterinary clinics, naturopaths, and non-institutional
pharmacies involved in non-sterile and compounding.
Source. #13028, eff 4-11-20
PART Ph 2106 SELF-INSPECTIONS
Ph 2106.01 Self-Inspection Requirements.
(a)
A self-inspection shall be conducted in accordance with, and documented
upon, the self-inspection survey provided by the pharmacy board.
(b)
Upon a required self-inspection, the pharmacy board shall email to each
licensee either:
(1) A “Retail
Self-Inspection Survey,# ph538” revised 11/1/2018, or
(2) An
“Institutional Self-Inspection Survey, #ph 557” revised 11/1/2018.
(c)
Licensees shall complete all self-inspection surveys within 7 days of
receipt.
(d)
A self-inspection shall include environmental monitoring reports, if
applicable under Ph 404, for board review.
(e) The original self-inspection form
shall be printed, signed, dated, and kept on file in a readily available format
upon pharmacy board inspection for 4 years.
Source. #13028, eff 4-11-20
Ph 2106.02 Required Self-Inspections by Risk Level.
(a)
A low risk facility shall conduct a self-inspection each year in which
it is not inspected by the pharmacy board.
(b)
A medium risk facility shall conduct a self-inspection upon request by
the pharmacy board.
(c)
The pharmacy board shall request a self-inspection under (b) above upon
receipt of a complaint involving the facility, upon receipt of a controlled
drug loss form, or as a follow-up self-inspection after a regular board
inspection.
Source. #13028, eff 4-11-20
Ph 2106.03 Self-Inspection for Change of the
Pharmacist-in-Charge.
(a) A self-inspection shall be required
within 7 days of a pharmacy board-approved change in a
pharmacist-in-charge.
Source. #13028, eff 4-11-20
(b)
A copy of the “change in pharmacist-in-charge” application, outlined in
Ph 700, shall be on file and readily retrievable upon pharmacy board inspection
or on request of the pharmacy board.
Source. #13028, eff 4-11-20
PART Ph 2107 INSPECTION PROCESS
FOR PRACTITIONERS
Ph 2107.01 Inspection Practices. The pharmacy board shall develop inspection
practices related to the practice of pharmacy for the following regulatory
boards as stated in RSA 318:8-a and RSA 318:9-a:
(a)
Board of medicine;
(b)
Board of nursing;
(c)
Board of dental examiners;
(d)
Board of veterinary medicine;
(e)
Board of podiatry;
(f)
Board of registration in optometry; and
(g) Naturopathic
board of examiners.
Source. #13028, eff 4-11-20
Ph 2107.02 Performance of Inspections.
(a) Inspections
shall
be performed, after presentation of proper identification, by pharmacy
board investigators, inspectors, or commissioners, and he or she shall have
access to all records concerning the purchase, storage, labeling, distribution,
compounding, reconstitution, and disposal of prescription drugs.
(b) Inspections
for licensees of the boards included in RSA 318:8-a and RSA 318:9-a, shall
include:
(1)
Verification of active DEA number and prescription monitoring program
registration and all delegates;
(2) General
facility and security related to the practice of pharmacy;
(3) Proper
storage of medications;
(4) Proper
labeling of medications;
(5) Complete
record keeping of distribution of control drug medications;
(6) Proper
disposal of medications; and
(7) Purchasing
information of medications.
(c)
Inspections for licensees involved with non-hazardous sterile and
non-sterile compounding of medications as stated in 318:14-a shall include:
(1)
Verification of patient specific medications;
(2) Purchasing
information from pharmacy board-licensed wholesaler/manufacturer;
(3) Training of
personnel in aseptic technique and available for review;
(4) Standards
of practice policy and procedure for injectable or intravenous medications; and
(5) Policy and
procedure to ensure environment meets minimum requirements related to the practice of pharmacy.
(d) Inspections for licensees involved with
hazardous sterile compounding of medications as stated in 318:14-a shall
include:
(1)
Demonstrated adherence with Ph 404 standards concerning sterile compounding;
(2) Be licensed with the pharmacy board as an institutional pharmacy/infusion center;
(3) Policies and
procedures for hazardous spills related to the practice of pharmacy; and
(4) The spill
kit in the facility.
Source. #13028, eff 4-11-20
2107.03
Inspection Frequency for Practitioners. Practitioner inspections shall occur based on
a risk assessment level assigned by pharmacy board compliance staff based on
the factors in Ph 2107.04 through 2107.06.
Source. #13028, eff 4-11-20
Ph 2107.04 Category I: High Risk. The following providers’ offices that
dispense or administer prescription medications shall be inspected biennially:
(a)
Veterinarians in private practice offering intravenous services for
non-sterile and sterile compounding of medications;
(b)
Animal hospitals/clinics;
(c)
Oral surgeons;
(d)
Ambulatory surgical units (ASUs);
(e)
Provider offices offering intravenous services for sterile compounding;
and
(f)
Naturopath providers offering intravenous services.
Source. #13028, eff 4-11-20
Ph 2107.05 Category II: Medium Risk. For the following providers without
controlled substances who dispense or administer prescription medications,
inspections shall be every 3 years:
(a)
Private practice providers without a hospital/HMO affiliation, also
known as independent private practice providers; and
(b)
Veterinarians in private practice.
Source. #13028, eff 4-11-20
Ph 2107.06 Category III: Low Risk. For the following providers without controlled
substances who dispense or administer prescription medications, inspections
shall be upon request of the provider’s board or provider:
(a)
Private practice physicians with a hospital/HMO affiliation;
(b)
Providers who are always affiliated with a hospital/HMO;
(c)
Naturopath providers with no prescription legend medications; and
(d)
Other health care providers with no prescription legend medications.
Source. #13028, eff 4-11-20
PART Ph 2108 INSPECTION REPORTS
Ph 2108.01 Inspections.
(a)
Inspections for pharmacy licensees, and licensees of the boards included
in RSA 318:9-a and 318:8-a, shall include the certification listed in (d) and
inspectors shall use the following forms:
(1) For retail
pharmacies, all matter included in the “Retail Pharmacy-Inspection Form, #ph
511” revised 11/1/2018, available on the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(2) For
institutional pharmacies, all matter included in the “Institutional
Pharmacy-Inspection Form, #ph 519” revised 11/1/2018, available on the pharmacy
board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(3) For long
term care pharmacies, all matter included in the “Long Term Care
Pharmacy-Inspection Form, #ph 516” revised 11/1/2018, available on the pharmacy
board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(4) For
methadone clinics, all matter included in the “Methadone Clinic-Inspection
Form, #ph 517” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(5) For manufacturers and wholesalers, all matter included
in the “Manufacturer/Wholesaler-Inspection Form, #ph 518” revised 11/1/2018,
available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(6) For practitioners and clinics, all matter included
in the “Practitioner/Clinic-Inspection Form, #ph 554” revised 11/1/2018,
available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(7) For public
health clinics, all matter included in the “Public Health Clinic-Inspection
Form, #ph 520” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(8) For naturopathic practitioners and clinics, all
matter included in the “Naturopathic Practitioner/Clinic Inspection Form, #ph
560” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(9) For
facilities which maintain controlled substances, all matter included in the
“Controlled Substance-Inspection Form, #ph 512” revised 11/1/2018 available on
the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(10) For home
infusion and sterile compounding facilities, all matter included in the “Home
Infusion/Sterile Compounder-Inspection Form, #ph 513” revised 11/1/2018,
available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(11) For
prescription device and medical gas distributors, all matter included in the
“Inspection Form Prescription Device/Medical Gas Distributors, form # ph 515,” revised 11/1/2018, available on the
pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(12) For break
policies involving pharmacists, all matter included in the “Pharmacist Break
Policy Supplemental Inspection Form ph 553,” revised 11/1/2018, available on
the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm. and;
(13) For
practitioners offices, all matter included in the “Facilities performing IV
infusion according to Manufacturer Labeling or Aseptic Technique Form # ph 559”
revised 11/1/2018, available on the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(14) For
compounding and dispensing parenterals in an institutional setting USP 795/797
inspection form Ph 514 revised 11/1/18, available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(15) For
compounding and dispensing non-sterile preparations, compounding audit
inspection form Ph 563 revised 11/1/19, available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(16) For
compounding and dispensing sterile preparations, compounding audit inspection
form Ph 564, revised 11/1/19, available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(b)
Upon inspection, all prescription and medication files requested by the
investigator or inspector shall be
available on demand.
(c)
If, during the course of an inspection, the inspector identifies a
violation of an administrative rule, the inspector shall issue a minor or major
violation notice to the licensee as stated in Ph 2200 and Ph 2109.
(d)
The inspection forms listed in (a) above shall require a
representative’s signature on the following certification:
My signature
acknowledges my awareness and understanding of all entries and notations made
on this report and my receipt of a copy
thereof. I also understand my
responsibilities for corrective action as outlined above.
Source. #13028, eff 4-11-20
Ph 2108.02 Inspection Report Requirements.
(a)
Inspectors or investigators shall have all inspection reports, that is,
forms as described in Ph 2108.01, reviewed and signed by the pharmacist on duty
or designated representative at the completion of an inspection.
(b)
A copy of the inspection report shall be provided to the licensee or
registrant and shall be made available, in a readily retrievable manner, on
request of the pharmacy board.
(c)
Inspection report results shall be:
(1)
Satisfactory, indicating no issues or violations;
(2)
Unsatisfactory, indicating the finding of a violation; and
(3) Not
applicable.
(d)
If an “unsatisfactory” result on a pharmacy inspection occurs, the
pharmacist-in-charge shall be required to do the following:
(1) Immediately
fix the issues noted by the investigator or inspector and respond in writing to
the pharmacy board within 10 days with a detailed report on the actions taken;
(2) If an
immediate fix is not possible, then a detailed action plan shall be developed
with a timeline that shall be approved by the investigator or inspector; or
(3) Schedule an
immediate follow up inspection, if applicable.
(e)
If an “unsatisfactory” result on a provider inspection occurs, the
report shall be forwarded to the respective board for review.
(e) T he current compliance inspection
report of the licensed location, conducted by the board, shall be kept on file
in the facility per Ph 703.06.
(f)
Inspection reports shall be stored by the pharmacy board in a licensing
data base by name of the permit holder and the pharmacist-in-charge.
Source. #13028, eff 4-11-20
PART Ph 2109 VIOLATION AND
VIOLATION NOTICES
Ph 2109.01 Violation Notices.
(a)
The board inspector shall issue a violation notice to a licensee should the
inspector find, during the course of an inspection, noncompliance with an
administrative rule or federal, state, or local law related to the practice of
pharmacy. A licensee or practitioner may contest any notice of violation as
provided in Ph 2207.02.
(b)
All violation notices shall be forwarded to the respective regulatory
board of the licensee for review and appropriate action.
(c)
Violations of rules under RSA 318-B shall result in a fine by the
pharmacy board.
(d)
Violation notices that are not appealed, or that are determined to be
founded after appeal, shall be kept on file in an appropriate licensing data
base of the pharmacist-in-charge and permit holder. All violation notices shall
be readily retrievable upon inspection, investigation, or request of the
pharmacy board for a period of 2 years.
Source. #13028, eff 4-11-20
Ph 2109.02 Minor Violations.
(a)
The minor violations shall be as listed in Ph 2109.07.
(b)
Remedying any minor violations shall be the responsibility of the
pharmacist-in-charge and the permit holder. All corrective action taken shall
be documented and mailed to the pharmacy board office with 15 days of
notification.
(c)
The investigator/inspector shall review remediation and respond if not
satisfactory.
(d)
All minor violation notices shall be made available to the pharmacy
board at next scheduled meeting.
(e)
Repeat minor violations shall result in board review with a
consideration for further disciplinary action under RSA 318:29.
Source. #13028, eff 4-11-20
Ph 2109.03 Major Violations.
(a)
Major violations shall as listed in Ph 2109.08.
(b)
All major violations for those regulated by the board of pharmacy shall
be the responsibility of the pharmacist-in-charge and the permit holder. The
pharmacist-in-charge and the pharmacist on duty at the time of violation shall
be responsible for correcting the violation. This corrected action shall be
recorded on the violation notice and returned to the inspector or investigator
within 15 days of receiving the notification.
(c)
Major violations shall be reviewed by the pharmacy board at the next
scheduled meeting for possible further disciplinary action.
(d)
Major violations for practitioners shall be referred to the respective
regulatory board for review.
Source. #13028, eff 4-11-20
Ph 2109.04 Drug Monitoring Program Violation
Notifications.
(a)
Any person or entity who fails to submit the information required in RSA
318-B:33, or knowingly submits incorrect information, shall be subject to a
warning letter and provided with an opportunity to correct the failure.
(b)
Any person or entity who subsequently fails to correct such failure, or
who fails to resubmit the information, shall be subject to discipline by the
board in reference to RSA 318-B:36.
Source. #13028, eff 4-11-20
Ph 2109.05 Administrative Fines. Violations found in the course of an
inspection shall be subject to administrative fines pursuant to Ph 2207.02.
Source. #13028, eff 4-11-20
Ph 2109.06 Prescription Monitoring Program Audit.
(a)
Pharmacy board investigators/inspectors shall audit prescriptions at the
request of the PMP auditor during normal inspection;
(1) Auditor shall request from
pharmacy/provider 8 prescriptions from random sampling a minimum of 2 weeks
prior to inspection;
(2) Pharmacy board
investigators/inspectors shall verify data per audit procedure and return
copied information to auditor; and
(3) Pharmacy board
investigators/inspectors shall select 2 additional prescriptions for audit per
audit procedure.
(b)
Failure to provide or correct data per RSA 318-B:36, I shall be subject
to pharmacy board review and possible disciplinary action under RSA 318:29.
Source. #13028, eff 4-11-20
Ph 2109.07 Minor Violation Schedule. The following violations shall be considered
minor violations for which licensees shall be subject to a $25.00 fine:
(a)
General Violations:
(1) Pharmacist
license is not posted;
(2) Pharmacy
has insufficient equipment;
(3) The work area
is not orderly and clear of obstructions;
(4) Equipment
inspection/calibration issues;
(5) Pharmacy
permit not posted;
(6) Improper
security;
(7) Out of date
or mislabeled drug;
(8) Improper
drug storage;
(9) Improper
drug destruction;
(10) Improper
supervision of support personnel;
(11) Improper
registration procedures;
(12) Nametags;
(13) Improper
documentation of training;
(14) Improper
return to stock procedures;
(15) Improper
dispensing/labeling;
(16) No drug regimen
review;
(17) No P&P
manual;
(18) Food in Rx
refrigerator;
(19) Shelving
not clean and orderly;
(20) Outdated
drugs separate from active inventory;
(21) Quality
Assurance Info Unavailable;
(22) Quality
Assurance Meeting Held Quarterly;
(23) Purified
Water System Inadequate;
(24) No hot/cold running water;
(25) No CMEA
certificate;
(b)
Retail Violations:
(1)
Prescription lacks proper information;
(2) Counseling
area inadequate
(3) No
counseling by RPh;
(4) Do not fill
date followed;
(5) Allergies
not properly noted;
(6) No CPR
certification for vaccines;
(7) No vaccine
provider information;
(8) Vaccination
standing order;
(9) No lunch
break;
(10) No lunch
break signage;
(11) Improper automated dispensing
procedures;
(12) Improper
telephone/voicemail order intake;
(13) Patient care guidelines
incomplete;
(c)
Hospital violations:
(1) Area for
non-sterile compounding inadequate;
(2) Records for
non-sterile compounding
(3) Master
compounding formulary;
(4) Improper
procedures for IV preparation;
(5) Area for
preparation of sterile products;
(6) Improper
packaging procedures;
(7)
Cytotoxic/biohazardous procedures;
(8) Open
multi-dose vials expiration dates;
(d)
Controlled Substances:
(1) Controlled
substance vendor return confirmation;
(2) CII locked
or dispersed;
(3) No power of
attorney;
(4) Dispensing
record not available;
(5) Improper transfer
of prescription controlled substances;
(6) Controlled
substance prescription pharmacist sign/date;
(7)
Prescription 222 form records not in numerical order;
(8)
Non-compliant NH controlled drug loss/DEA 106 forms;
(9) Controlled
substances invoices not separated;
(10) No CII
monthly perpetual inventory;
(11) No
daily/nightly controlled substances log;
(12) Controlled
substances returns procedure inadequate;
(e)
PDMP:
(1) Failure to verify prescriptions
with the PDMP; and
(2) PDMP provider
verification.
Source. #13028, eff 4-11-20
Ph 2109.08 Major Violation Schedule. The following shall be considered major
violations:
(a)
F or which licensees be subject to a $100.00 fine:
(1) The failure
of equipment such as the medication/vaccine refrigerator or freezer, hot or
cold water, heat of air conditioning failure causing the pharmacy to be outside
the appropriate temperature range for proper drug storage per the manufacturer;
(2) Failure to
Maintain Temperature Logs;
(3) No Signage
on Hardcopy of C/S Rx;
(4) Printed C/S
Rx Not Marked Copy Only- Not Valid for Dispensing
(5) Immunizing Pharmacist or Immunizing Intern with
Expired CPR Certification or Liability Insurance Policy;
(6) CII
Inventory Missing or Incomplete;
(7) Failure to
Report Changes of Name, Address, or Work Location within 15 Days; and
(8) Pharmacist technician or intern working in the
pharmacy while unregistered or with an expired registration.
(b)
For which licensees shall be subject to a $250.00 fine:
(1) DEA 222
forms were not sent to the DEA; and
(2) A
registered pharmacy technician has been performing certified pharmacy
technician duties.
(c)
For which the licensee shall be subject to a $500.00 fine:
(1) The
biennial inventory is missing or not done;
(2) A failure
to report a controlled substance loss;
(3) A
pharmacist has been working in the pharmacy while unlicensed or with an expired
license;
(4) The
pharmacy is an unfit place to work;
(5) The pharmacy
failed to report a change of its pharmacist-in-charge in a timely manner;
(6) No
pharmacist-in-charge change inventory was done;
(7) The
pharmacy has been operating without a pharmacist-in-charge; and
(8) Issues with
pharmacy access or security.
(d)
The licensee shall be subject to a $1,000.00 fine if the pharmacy is not
registered with the PDMP.
(e)
The licensee shall be subject to a $5,000.00 fine if the licensee has
failed to respond to a violation notice or report of investigation.
Source. #13028, eff 4-11-20
CHAPTER Ph 2200 PHARMACY
BOARD INVESTIGATIONS
PART Ph 2201 DEFINITIONS
Ph 2201.01 Definitions. In addition to RSA 318:1, the following
definitions shall apply to this chapter:
(a)
“Board investigator” means a pharmacist
employed by the pharmacy board to investigate violations of the pharmacy laws
or the rules of the pharmacy board by a person licensed at the time the alleged
violation occurred;
(b)
“Confidential letter of concern” means a warning letter issued by the
pharmacy board to a licensee as a type of outcome to an investigation conducted
by the pharmacy board investigators;
(c) “Drug diversion” means the illegal
distribution of prescription controlled drugs, or transfer of any legally prescribed controlled substance from the individual for whom it
was prescribed to another person for any illicit use;
(d)
“Facility” means any pharmacy,
hospital, clinic, practitioner offices, methadone clinic, orveterinarian clinic
that have medication on their premises and are inspected by the pharmacy board;
(e)
“Infusion center” means a place, usually outpatient, where patients can
receive intravenous infusions and therapeutic injections in a safe,
professional, and comfortable environment;
(f)
“Licensee” means any entity or individual which is licensed, certified,
registered, or regulated by the pharmacy board or a board whose licensees are subject
to investigation under RSA 318:30;
(g)
“Medication error” means any
preventable event that may cause or lead to inappropriate medication use or
patient harm, while the medication is in the control of the healthcare
professional or patient. Such events can be related to professional practice,
healthcare products, procedures, and systems including prescribing, order
communication, product labeling, packaging and nomenclature, compounding,
dispensing, distribution, administration,
education, monitoring, and use.
(h)
“Methadone clinic” means a clinic which has been established for the dispensing of methadone, a schedule II drug under the Controlled Substance Act, for the purpose of treating
addiction disorder;
(i)
“Naturopathic medicine” means “naturopathic medicine” as defined in RSA
328-E:2, IX, namely, “a system of primary health care practiced by doctors of
naturopathic medicine for the prevention, diagnosis, and treatment of human
health conditions, injuries, and disease that uses education, natural
medicines, and therapies to support and stimulate the individual’s intrinsic
self-healing processes;”
(j)
“Nurse practitioner” means a
registered nurse currently licensed by the board under RSA 326-B:18. The term includes “advanced practice
registered nurse (APRN).;
(k)
“Professional misconduct” means behavior by a
professional that implies an intentional compromise of ethical standards,
including the acts specified in RSA 318:29, II;
(l)
“Quality related event (QRE)” means the
incorrect dispensing of a prescribed medication that is received by a patient,
including a variation from the prescriber’s prescription order, or failure to
identify and manage errors identified during a drug utilization review; and
(m) “Tele-pharmacy service” means the delivery of pharmaceutical care via telecommunications to patients in
locations where they may not have direct contact with a pharmacist.
Source. #12997, eff 3-5-20
PART Ph 2202 PURPOSE AND SCOPE
Ph 2202.01 Purpose. This part describes how the pharmacy board
conducts investigations as authorized by RSA 318:8-a, RSA 318:14-a, RSA 318:30,
and RSA 318:42.
Source. #12997, eff 3-5-20
Ph 2202.02 Scope.
This section shall apply to any party licensed by the pharmacy board or
party licensed by another regulatory board that has given investigatory
authority to the pharmacy board of pharmacy under RSA 318:30.
Source. #12997, eff 3-5-20
PART Ph 2203 CONSUMER COMPLAINTS
Ph 2203.01 Consumer Complaints.
(a)
Consumer complaints shall be filed using the administrative complaints packet
Ph 532, revised 11/1/18, containing “Complaint cover sheet form Ph 533,”
revised 11/1/18, “Pharmacy/Pharmacist Complaint Form” (Ph 534), revised
11/1/2018, and “Release of Medical Information form Ph 535,” revised 11/1/18,
available on the pharmacy board website at https://www.oplc.nh.gov/pharmacy/complaints.htm.
(b)
All complaints that meet the minimum technical requirements by
identifying a licensee and facts, which, if true, could be a violation subject
to the pharmacy board’s jurisdiction, shall be addressed by the pharmacy board
compliance staff. A report of investigation shall be issued to the pharmacy
board for review and further action if required.
(c)
Investigations shall be assigned by the pharmacy board
administrator/chief of compliance.
(d)
The pharmacy board shall dismiss any complaint that is not filed in
accordance with this chapter or that fails to state a cause of action pursuant
to RSA 318:30, VII.
Source. #12997, eff 3-5-20
PART Ph 2204 RESPONSES
Ph 2204.01 Quality Related Event Reports.
(a)
The board investigator shall issue “Quality Related Event (QRE) Report”
forms (Ph 530), revised 3/19, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm, to licensees for information
concerning the allegations of a complaint.
(b)
A licensee who received a “QRE Report” shall:
(1) If a pharmacist, pharmacy technician, or person
directly involved in the complaint, complete a “QRE Report” form;
(2) If a permit holder or corporate entity,
complete a separate “QRE Report”; and
(3) Sign and return the completed form to the board
investigator within 15 days of receipt pursuant to RSA 318:30 VIII.
Source. #12997, eff 3-5-20
PART Ph 2205 INVESTIGATIONS
Ph 2205.01 Licensees Subject to Investigations. The following licensees and medical providers
shall be subject to investigations:
(a)
Licensees of the pharmacy board including:
(1) Pharmacies, pharmacists, and pharmacy
technicians;
(2) Permit holders including:
a. Tele-pharmacy service providers;
b. Methadone clinics;
c. Infusion centers; and
d. All other facilities where medications are
administered, stored, or dispensed;
(3) Wholesalers, manufacturers, and distributors
of pharmaceuticals and pharmaceutical devices;
(4) Medical gas providers; and
(5) Out of state permit holders under RSA 318:37
II(d);
(b)
Other medical providers pursuant to RSA 318:8-a and RSA 318-B, including:
(1) Physicians;
(2) Nurse practitioners;
(3) Physician assistants;
(4) Naturopaths;
(5) Podiatrists;
(6) Optometrists;
(7) Dentists; and
(8) Veterinarians with prescriptive authority.
Source. #12997, eff 3-5-20
Ph 2205.02 Investigations of a Complaint.
(a)
Investigations into complaints shall be done by pharmacy board
commissioners and pharmacy board investigators in conjunction with pharmacy
board counsel and the administrative prosecution unit (APU) of the NH
department of justice.
(b)
Investigations shall focus on evidence of:
(1) Professional misconduct;
(2) Medication errors;
(3) Drug diversion;
(4) Violation of federal or state law and the
rules of the pharmacy board;
(5) FDA recalls;
(6) Noncompliance with the prescription drug
monitoring program;
(7) Unsanitary conditions, as per Ph 404.03 and United
States Pharmacopia (USP) 797; and
(8) Any condition, issue, or event related to the
practice of pharmacy, pharmaceutical product, or prescriptive device that
jeopardizes patient safety.
(c)
Investigators shall be authorized by the pharmacy board to:
(1) Obtain factual evidence to gain an
understanding of the complaint allegations;
(2) Conduct interviews with complainant, respondent,
or any other person thought to have knowledge of the incident which gave rise
to the complaint;
(3) Issue a “QRE Report” form to a party to the
complaint;
(4) Request
information from outside sources needed to investigate the complaint or issue
identified for investigation;
(5) Consult with pharmacy board counsel or the
APU; and
(6) Obtain any relevant information or data
regarding external variables that negatively impact the safe practice of
pharmacy including but not limited to:
a. Working conditions;
b. Staffing;
c. Training;
d. Facility conditions;
e. Equipment;
f. Power; and
g. The weather.
Source. #12997, eff 3-5-20
Ph 2205. Follow Up to Investigations.
(a)
The pharmacy board administrator/chief of compliance shall follow up
with a complainant as to the outcome of the investigation.
(b) Unfounded investigation reports and pharmacy
board actions shall be kept on file by the pharmacy board for 5 years. Founded
pharmacy board actions shall be attached to the license of the pharmacist or
pharmacist-in-charge and the pharmacy permit holder.
Source. #12997, eff 3-5-20
Ph 2205.04 Cost of the Investigation.
(a)
All costs associated with an investigation shall be reported to the
respective regulatory board of the licensee for tracking and potential
assessing of investigation cost under RSA 332-G:11.
(b)
Costs involved with an investigation shall include:
(1) The cost of the investigator at a cost per
hour rate;
(2) The cost of the office staff timed at a cost
per hour rate;
(3) The cost of the pharmacy board counsel or APU
at cost per hour rate;
(4) Costs associated with travel of the above
persons; and
(5) Other costs as deemed necessary by the
pharmacy board.
Source. #12997, eff 3-5-20
PART Ph 2206 INVESTIGATION
REPORTS
Ph 2206.01 Reports of Investigation.
(a) Pharmacy board investigators shall review
all information concerning technically sufficient complaints and prepare a
report of investigation for pharmacy board review.
(b)
The report of investigation shall include, but need not be limited to:
(1) The name and license number or permit number
of all accused;
(2) The origin or nature of the allegations;
(3) All background information gathered during
the investigation;
(4) The sources of all information gathered in
the investigation;
(5) The results of the investigation;
(6) A summary of the investigation, when
relevant;
(7) The relevant laws and rules for consideration
of the complaint; and
(8) The investigator’s recommendation to the
pharmacy board for further action or for dismissal.
Source. #12997, eff 3-5-20
Ph 2206.02 Notification of Violations. If, in the course of their investigation, a board
investigator finds a violation of an administrative rule in plain sight, then
the investigator shall issue a violation notice pursuant to the rules in Ph
2100.
Source. #12997, eff 3-5-20
Ph 2206.03 Prescription Drug Monitoring Program
Investigations. All pharmacy board
investigations concerning the prescription drug monitoring program shall be
referred to the respective board of the licensee upon completion.
Source. #12997, eff 3-5-20
PART Ph 2207 DISCIPLINARY
ACTION
Ph 2207.01 Pharmacy Board Action.
(a)
The pharmacy board shall review the completed reports of investigation
at their next scheduled pharmacy board meeting.
(b)
After review and after considering the factors set forth in (e) below,
the pharmacy board shall take action in one or more of the following ways:
(1) Refer to the board investigator for further
investigation;
(2) Dismiss the complaint;
(3) Issue a confidential letter of concern; or
(4) Impose disciplinary action in the form of fines,
public reprimands, additional education, suspension or revocation of license,
or other corrective action following notice and an opportunity for a hearing or
other action as stated in RSA 318:29, (IV) and (V). In considering which form of disciplinary
action to take, the pharmacy board shall consider the factors set forth in (e)
below.
(c)
In cases where the individual investigated is a licensee of another
board, the pharmacy board shall refer the report of investigation to that
respective board with recommendations.
(d) Disciplinary action concerning a reprimand,
fine, additional continuing education, the suspension or revocation of a
license, or any action resulting in a restriction on a pharmacy or pharmacist
license, shall be reported to the National Board of Pharmacy and National
Provider databases.
(e) In all cases of disciplinary action under Ph
2207.01(b) above, the pharmacy board shall consider:
(1) The nature of the offense;
(2) The purpose of the rule or statute violated;
(3) The licensee's state of mind at the time the
offense occurred;
(4) The potential harm to the public health;
(5) The deterrent effect upon other
practitioners;
(6) The licensee's willingness to cooperate with
the pharmacy board;
(7) The cost to the pharmacy board of any formal
disciplinary hearings which were necessary;
(8) The licensee's acknowledgment of his or her
wrongdoing; and
(9) The nature of any other disciplinary sanctions
imposed as a result of the offense in question.
Source. #12997, eff 3-5-20
Ph 2207.02 Administrative and Disciplinary Fines.
(a)
Persons subject to the disciplinary authority of the pharmacy board and
other persons subject to administrative fines or penalties under RSA 318:29, IV
or RSA 318:55, II shall after notice and an opportunity to be heard, be
assessed fines and penalties as authorized under RSA 318:29, IV.
In considering
the amount of fines and penalties to assess, the pharmacy board shall consider
the factors set forth in (b) through (i) below.
(b) The decision to impose a fine and the amount
of such fine shall depend on:
(1) The severity of harm to the
public posed by the violation;
(2) The number of concurrent or
repeated violations; and
(3) The frequency of violations
committed by the particular licensee, permit holder, or other person.
(c) Minor violations as listed in Ph 2109.02(d)
and on form Ph 542 “Minor Violation Notice” shall be subject to a fine of
$25.00 for each offense with a maximum of $250.00 per Ph 710.01 and Ph 710.02.
(d) Fines shall be paid within 15 days, or a
hearing shall be requested in front of the pharmacy board.
(e) When no violation of the same type has
occurred within the 5 years preceding the pharmacy board's notice to the
respondent, the fine assessed shall not exceed $1,000 per violation upon the
licensee or $2,000 per violation upon the permit holder.
(f) When a single disciplinary infraction of the
same type has occurred within the 5 years preceding the pharmacy board's notice
to the licensee, the fine assessed shall not exceed $2,000 per violation upon the
licensee or $3,000 per violation upon the permit holder.
(g) When more than one disciplinary infraction of
the same type has occurred within the 5 years preceding the pharmacy board's
notice to the licensee, the fine assessed shall not exceed $3,000 per violation
upon the licensee or $5,000 per violation upon the permit holder.
(h) In the case of continuing violations, a
separate fine shall be assessed for each day the violation continues, but the
total amount of the fine and the licensee's promptness and cooperativeness in
ceasing the prohibited conduct in question shall be considered in assessing the
daily fines.
(i) In all cases, the pharmacy board shall
consider:
(1) The nature of the offense;
(2) The purpose of the rule or
statute violated;
(3) The licensee’s state of
mind at the time the offense occurred;
(4) The potential harm to the
public health;
(5) The deterrent effect upon
other practitioners;
(6) The licensee’s willingness to
cooperate with the pharmacy board;
(7) The cost to the pharmacy
board of any formal disciplinary hearing which were necessary;
(8) The licensee’s
acknowledgement of his or her wrongdoing; and
(9) The nature of any other
disciplinary sanctions imposed as a result of the offense in question.
Source. #12997, eff 3-5-20
Rule
|
|
Ph 103.01 |
RSA 318:2 |
Ph 104.03 |
RSA 318:5-a, VII; RSA 318:25, II |
|
|
Ph 201-204 |
RSA 318:5-a, VIII; RSA 318:30 –
31; RSA 541-A:16, I (b)(2) |
Ph 205 |
RSA 318:31, V; RSA 541-A:16, I
(b)(2) |
Ph 206 |
RSA 541-A:16, I (d) |
Ph 207 |
RSA 541-A:16, I (c) |
Ph 208 |
RSA 541-A:16, I (b)(3) |
Ph 209 |
RSA 541-A:11, VII; RSA 541-A:16, I (b) intro. |
|
|
Ph 301.01 |
RSA 318:5-a, I, III; RSA 318:18 |
Ph 301.02 |
RSA 318:5-a, II; RSA 318:18; RSA 318:19 |
Ph 301.03 |
RSA 318:5-a, I; RSA 318:10; RSA 318:18 |
Ph 301.04 |
RSA 318:5-a, IV; RSA 318:10 |
Ph 301.05 |
RSA 318:5-a, IV |
Ph 301.06, Ph 301.07 |
RSA 318:10; RSA 318:18, II; RSA 318:29, I |
Ph 302.01 |
RSA 318:21 |
Ph 302.02 |
RSA 318:21 |
Ph 302.03 |
RSA 318:21 |
Ph 302.04, Ph 302.05, Ph 302.06 |
RSA 318:21 |
Ph 302.07 |
RSA 318:5-a, VII |
Ph 302.08, Ph 302.09 |
RSA 318:5-a, IV |
Ph 303 |
RSA 318:5-a, I, II, IV-a, V, VII |
Ph 303.02 (d), (h), and (j) |
RSA 318:5-a, XIV |
Ph 304.01 |
RSA 318:38, I, II, III |
Ph 304.02 |
RSA 318:38, III; RSA 318:39 |
Ph 305, Ph 306 |
RSA 318-B:23 |
Ph 306.01(d) |
RSA 318:5-a, II and IV-a |
Ph 306.05(c) |
RSA 318:38, III |
Ph 307 |
RSA 318:38, III; RSA 318-B:25 |
Ph 308 |
RSA 318:5-a, VII |
Ph 309 (moved to Ph 1000) |
|
|
|
Ph 401.01 |
RSA 318:5-a, I,III, V, VII, and VII-a |
Ph 401.02 (a) and (b) |
RSA 318:25 |
Ph 401.02(c) and (d) |
RSA 318:5-a, VII and RSA 318:16-b, IV |
Ph 401.02(e) |
RSA 318:29-a, VI (b) |
Ph 401.03 - Ph 401.05 |
RSA 318:26 |
Ph 401.06 - Ph 401.07 |
RSA 318:5-a, II |
Ph 401.07 |
|
Ph 402.01 - Ph 402.04 |
RSA 318:5-a, VI, VII |
Ph 403.01 - Ph 403.02 |
RSA 318:29, I, II, IV, V; RSA
318:5-a,VII-a |
Ph 403.03 – Ph 403.13 |
RSA 318:25, III |
Ph 404 |
RSA 318:5-a, II, IV-a |
Ph 405 |
RSA 318:5-a, II, IV-a |
|
|
Ph 500 |
RSA 318:5-a, VI |
Ph 501.01 |
RSA 318:5-a, IV |
|
|
Ph 601.01 – Ph 601.04 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
Ph 601.05 |
RSA 318:5-a, VII |
Ph 601.06 – Ph 601.16 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
Ph 601.06 – Ph 601.10(a)-(c) |
RSA 318:5-a, I, II, III, IV-a, V,
VI, and VII; RSA 318:51-b |
Ph 601.01 (e) |
RSA 318:5-a, VII |
Ph 601.10(d) |
21 CFR 1301.72(a) |
Ph 601.10 (e)-(h) |
RSA 318:5-a, II; RSA 318:51-b, II(b) |
Ph 601.11 |
RSA 318:51-b, I, II(d) |
Ph 601.12(a) |
RSA 318:51-b, I, II(d) |
Ph 601.12(b) |
21 CFR 1301.74(h) |
Ph 601.13 |
RSA 318:51-b, I, II(b) and (d) |
Ph 601.14 |
RSA 318:51-b, I |
Ph 601.14 (c)(5) |
RSA 318:51-b, II(d) |
Ph 601.15- Ph 601.17 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
Ph 602 |
RSA 318:51-b |
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|
Ph 701.01 – Ph 701.02 |
RSA 318:5-a, IV-a |
Ph 701.03 |
|
Ph 702.01 – Ph 702.04 |
RSA 318:5-a, II, IV-a |
Ph 702.01 (b)(3) |
RSA 318:5-a, II |
Ph 702.05 |
RSA 318:5-a, XIV |
Ph 702.06 – Ph 702.07 |
RSA 318:5-a, IV-a |
Ph 703.01 – Ph 703.05 |
RSA 318:5-a, III, IV-a, IX |
Ph 703.02 (b)(2) |
RSA 318:5-a, IV-a |
Ph 703.06 |
RSA 318:5-a, IV-a |
Ph 703.07 |
RSA 318:46; RSA 318:47; RSA 318-B:12 |
Ph 704.01 |
RSA 318:5-a, XIV, IV-a |
Ph 704.02 – Ph 704.06 |
RSA 318:5-a, II, III, IV-a, XV |
Ph 704.03 |
RSA 318:5-a, III, and IV-a |
Ph 704.04 intro., (a) – (d) |
RSA 318:5-a, III, and IV-a |
Ph 704.06 (b), (c), (f) |
RSA 318:5-a, III, IV-a, and XV |
Ph 704.07 (a), (b) |
RSA 318:38, I |
Ph 704.08 – Ph 704.13 |
RSA 318:47-c |
Ph 704.11 |
RSA 318:5 a, IV-a |
Ph 704.14 |
RSA 318:52-a |
Ph 704.15 (a), (b), (d), (e) |
RSA 318-B:9, I, III, IV |
Ph 704.16 |
RSA 318:29, V, (g)(h) |
Ph 705.01 – Ph 705.02 |
RSA 318:5-a, IV-a, RSA 318:38, I |
Ph 705.03 (a) – (d) |
RSA 318:38, I |
Ph 706 |
RSA 318:5-a, IV-a |
Ph 707.01 |
RSA 318:5-a, IV-a |
Ph 707.02 |
RSA 318:5-a, , II, III, IV-a |
Ph 707.02 (a) |
RSA 318:5-a, III, IV-a |
Ph 707.02 (b)(1) |
RSA 318:5-a, II |
Ph 707.02 (b) (7) |
RSA 318:5-a, III |
Ph 707.03 |
RSA 318:5-a, IV-a |
Ph 707.04 |
RSA 318-B:17-a, RSA 318:5-a, IV-a |
Ph 707.05 – Ph 707.06 |
RSA 318:5-a, IV-a |
Ph 708.01 |
RSA 318:5-a, III, IV-a, IX |
Ph 708.02 |
RSA 318:47 |
Ph 708.03 |
RSA 318-B:9, II |
Ph 709.01 |
RSA 318:5-a, IV-a and XV |
Ph 709.02 |
RSA 318:5-a, IV-a |
Ph 709.03 –Ph 709.06 |
RSA 318:5-a, IV-a, and XII |
Ph 709.05 |
RSA 318:5-a, IV-a; RSA 318:42 |
Ph 709.07 - Ph 709.09 |
RSA 318:5-a, IV-a |
Ph 710.01 – Ph 710.02 |
RSA 318:5-a, IV-a, VII; RSA 318:29, IV |
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|
Ph 801.01 |
RSA 318:5-a, X (a); RSA 541-A:7 |
Ph 802.01 |
RSA 318:5-a, X (a); RSA 541-A:7 |
Ph 803.01 |
RSA 318:5-a, X (a); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 803.02 |
RSA 318:5-a, X (a); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 804.01 |
RSA 318:5-a, X (f); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 805.01 |
RSA 318:5-a, X (b); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 805.02 |
RSA 318:5-a, X (b); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 806.01 |
RSA 318:5-a, X (d); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 806.02 |
RSA 318:5-a, X (g); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 807.01 |
RSA 318:5-a, X (b); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 807.02 |
RSA 318:5-a, X(b); RSA 318:15-a |
Ph 808.01 |
RSA 318:5-a, X (a); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 808.02 |
RSA 318:5-a, X (a); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 809.01 |
RSA 318:5-a, X (f); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 810.01 |
RSA 318:5-a, X (b); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 810.02 |
RSA 318:5-a, X (f); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 810.03 |
RSA 318:5-a, X (f); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 810.04 |
RSA 318:5-a, X (f); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 811.01 |
RSA 318:5-a, X (d); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 811.02 |
RSA 318:5-a, X (g); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 812.01 |
RSA 318:5-a, X (b); RSA 318:5-a,
XI; RSA 318:15-a |
Ph 812.02 |
RSA 318:5-a, X(b); RSA 318:15-a |
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|
Ph 900 |
RSA 318:5-a; RSA 318:37, II |
Ph 901.01 |
RSA 541-A:8 |
Ph 902.01 |
RSA 541-A:7; RSA 541-A:8 |
Ph 902.02 |
RSA 541-A:7; RSA 541-A:8 |
Ph 902.03 |
RSA 541-A:7; RSA 541-A:8 |
Ph 902.04 |
RSA 541-A:7; RSA 541-A:8 |
Ph 903 – Ph 907 |
RSA 318:37; RSA 318:38 |
Ph 903.01 (c)(7) |
RSA 318:5-a, VII |
Ph 903.01 (d) |
RSA 318:5-a, IV-a |
Ph 906.03 intro. and (d) |
RSA 318:5-a, I, IV-a |
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|
Ph 1000 |
RSA 318:5-a, I, II,
III, V, VII; RSA 318:42, III; RSA 318:51-a; RSA 318-B:3; RSA 318-B:5 |
Ph 1001.01 |
RSA 318:51-a, I |
Ph 1002.12 |
RSA 318:51-a, I |
Ph 1101.01 |
RSA 541-A:7 |
Ph 1102.01 |
RSA 318:1, XXV;
RSA 318:5-a, XVII(b) |
Ph 1102.02 |
RSA 318:1, XXVI;
RSA 318:5-a, XVII(b) |
Ph 1102.03 |
RSA 318:1,
XXVII; RSA 318:5-a, XVII(b) |
Ph 1102.04 |
RSA 541-A:7; RSA
318:5-a, XVII(b) |
Ph 1102.05 |
RSA 318:1, III;
RSA 318:5-a, XVII(b) |
Ph 1103.01 |
RSA 318:5-a, II,
XVII(b); RSA 318:16-a, I |
Ph 1103.02 |
RSA 318:5-a,
XVII (b); RSA 318:16-a, II |
Ph 1104.01 |
RSA 318:5-a. II,
III |
Ph 1105.01 |
RSA 318:5-a,
XVII(b); RSA 318:16-a, IV |
Ph 1105.02 |
RSA 318:5-a, VI,
XVII(b) |
Ph 1105.03 |
RSA 318:5-a,
XVII(b); RSA 318:16-a, IV |
Ph 1105.04 |
RSA 541-A:16, I(b)
intro.; RSA 318:5, II; RSA 318:5-a, XVII(b) |
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|
Ph 1201 |
RSA 541-A:7; RSA 541-A:8 |
Ph 1202 |
RSA 541-A:7; RSA 541-A:8 |
Ph 1203 |
RSA 318:5-a, XIII |
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|
Ph 1301.01 |
RSA 541-A:8 |
Ph 1301.02 |
RSA 541-A:8; RSA 318:5-a, IV-a |
Ph 1302 |
RSA 541-A:7; RSA 541-A:8; RSA
318:1, I, VII, and XV |
Ph 1303.01 |
RSA 318:16-b |
Ph 1303.02 |
RSA 318:5-a,III and RSA 318:16-b, IV |
Ph 1303.02 |
RSA 318:5-a,III; RSA 318:16-b,VI |
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|
Ph 1401 |
RSA 541-A:8; RSA 318:56 |
Ph 1402 |
RSA 541-A:7; RSA 541-A:8; RSA
318:57 |
Ph 1403 |
RSA 318:58 I; RSA 318:58 III |
Ph 1404 |
RSA 318:58 II; RSA 318:58 III |
Ph 1405 |
RSA 318:56, VI |
Ph 1406 |
RSA 318:58 |
Ph 1407 |
RSA 318:56 |
Ph 1408 |
RSA 318:58, III-a |
Ph 1409 |
RSA 318:56, VI |
Ph 1410 |
RSA 318:59; RSA 318:58 |
Ph 1411 |
RSA 318:60 |
Ph 1412 |
RSA 318:55 |
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|
Ph 1501.01 |
RSA 318-B:31-38 |
Ph 1502.01 |
RSA 318-B:31 |
Ph 1503.01 |
RSA 318-B:33, I & II |
Ph 1504.01 |
RSA 318-B:33, III, IV & V |
Ph 1504.02 |
RSA 318-B:33, VI |
Ph 1504.03 |
RSA 318-B:33, VII |
Ph 1505.01 – Ph 1505.05 |
RSA 318-B:35, I |
Ph 1506.01 – Ph 1506.02 |
RSA 318-B:35, II & III |
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Ph 1601- Ph 1608 |
RSA 318:5-a XI-a; 318:5-a XI-b;
and 318:15-b |
Ph 1602.01 |
RSA 318:15-b; RSA 541-A:7 |
Ph 1603.01 |
RSA 318:5-a, XI-a (a), (b); RSA
318:15-b |
Ph 1604.01 |
RSA 318:5-a, XI-a (a); RSA
318:5-b; RSA 318:15-b |
Ph 1605.01 |
RSA 318:5-a, XI-a (b), (c); RSA
318:15-b |
Ph 1606.01 |
RSA 318:5-a, XI-a (b); RSA
318:15-b |
Ph 1606.02 |
RSA 318:5-a, XI-a (b); RSA
318:15-b |
Ph 1607.01 |
RSA 318:5-a, XI-a, (d); RSA
318:15-b |
Ph 1608.01 |
RSA 318:5-a, XI-a, (f); RSA
318:15-b |
Ph 1608.02 |
RSA 318:5-a, XI-a, (f); RSA
318:15-b |
Ph 1608.03 |
RSA 318:5-a, XI-a, (f); RSA
318:15-b |
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|
Ph 1701.01 |
RSA 541-A:7; RSA 318:45-a, VII |
Ph 1701.02 |
RSA 541-A:7; RSA 318:45-a, VII; 42 U.S.C § 299b et
seq. |
Ph 1702.01 |
RSA 541-A:7; RSA 318:45-a, VII |
Ph 1703.01 |
RSA 318:45-a, VII |
Ph 1704 |
RSA 318:45-a, VII; 42 U.S.C § 299b et seq. |
Ph 1705 |
RSA 318:45-a, VII |
Ph 1706 |
RSA 318:45-a, VII |
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|
Ph 2001 |
RSA 541-A:7; RSA 318:51-c; RSA
318:51-d; RSA 318:51-d |
Ph 2002 |
RSA 541-A:7; RSA 318:1 |
Ph 2003 |
RSA 318:51-c; RSA 318:51-d; RSA
318:51-e |
Ph 2004 |
RSA 318:51-c, V, VI; RSA
318:51-e, IX |
Ph 2005 |
RSA 318:51-c, I; RSA 318:51-e,
I-IV, IX |
Ph 2006 |
RSA 318:51-d; RSA 318:51-e, VI -
VIII |
Ph 2007 |
RSA 318:51-d ; RSA 318:51-e, VII |
Ph 2008 |
RSA 318:51-d; RSA 318:51, e, IX |
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|
Ph 2101.01 |
RSA 318:5-a, IX; RSA 541-A:16,
I(b) |
Ph 2102.01 |
RSA 318:5-a, IX; RSA 318:8-a; RSA
318:9-a; RSA 318-B:25; RSA 541-A:16, I(b) |
Ph 2102.02 |
RSA 318:5-a, IX; RSA 318:8-a; RSA
318:9-a; RSA 318-B:25; RSA 541-A:16, I(b) |
Ph 2103.01 |
RSA 318:5-a, IX; RSA 541-A:16,
I(b) |
Ph 2104.01 |
RSA 318:5-a, IX; RSA 541-A:16,
I(b); RSA 318-B:25 |
Ph 2104.02 |
RSA 318:5-a, IX; RSA 318:8-a;RSA
318:9-a; RSA 318-B:25 |
Ph 2105.01 |
RSA 318:5-a, IX; RSA 541-A:16,
I(b); RSA 318-B:25 |
|
|
Ph 2201.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2202.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2202.02 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2203.01 |
RSA 318:30; RSA 318-B:24; RSA
318:47-h; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2204.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2205.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2205.02 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2205.03 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2206.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2206.02 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2206.03 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2207.01 |
RSA 318:30; RSA 318-B:24; RSA
318:29; RSA 318-B:26; RSA 318-B:36; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2207.02 |
RSA 318:30; RSA 318-B:24; RSA
318:29; RSA 318-B:26; RSA 318-B:36; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
Ph 2201.01 |
RSA 318:30; RSA 318-B:24; RSA
318:8-a; RSA 318:14-a; RSA 318:42 |
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