CHAPTER Jus 1600
PROCEDURES FOR PHARMACEUTICAL DRUG COLLECTION
Statutory Authority: RSA 318-E:1
PART
Jus 1601 PURPOSE AND SCOPE
Jus
1601.01 Purpose.
(a) The
purpose of these rules is to establish uniform procedures and standards for
collecting and disposing of expired or unwanted pharmaceutical drugs from
individuals in order to:
(1) Provide the public with an
environmentally safe, accessible and convenient
alternative to disposing of pharmaceutical drugs in the landfill or sewer
systems that may later negatively affect the environment; and
(2) Encourage individuals to remove expired or
unwanted pharmaceutical drugs from their households and residences to reduce
access to addictive drugs for accidental or intentional misuse by individuals,
especially children, in the home.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus 1601.02 Scope. Controlled
and non-controlled pharmaceutical drugs collected in accordance with this
chapter shall be exempt from the disposal requirements for controlled drugs
stipulated in RSA 318-B:17.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1602.01 “Collection box” means a secured receptacle with an inner
lining, into which pharmaceutical drugs can be deposited and which remains in
possession of designated law enforcement officers for the purposes of a
collection event.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1602.02 "Collection event" means a one-day program through
which the public can safely
dispose of unused or expired
pharmaceutical drugs from a household or residence that are no longer
wanted or needed by the consumer, at a secure collection site.
Source. #10177, eff
8-23-12; ss by #13551, eff 2-2-23
Jus
1602.03 ”Controlled drugs'' means “controlled drugs” as defined in
RSA 318-B:1, VI.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1602.04 “Department” means the department of justice.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1602.05 “Drop box” means a double-locked receptacle with an inner
lining into which pharmaceutical drugs are deposited, situated in a police station and constructed in a manner that prevents tampering
or access by non-authorized persons.
Source. #10177, eff
8-23-12; ss by #13551, eff 2-2-23
Jus
1602.06 “Inner lining” means a water proof, tamper-evident, and tear resistant lining that
shall be capable of sealing immediately upon removal from a receptacle.
Source. #13551, eff 2-2-23
Jus
1602.07 “Law enforcement officer” means any officer of the state or political
subdivision of the state whom is empowered by law to
conduct investigations of or to make arrests for offenses enumerated in RSA
318-B:2.
Source. #10177, eff 8-23-12;
ss by #13551, eff 2-2-23 (formerly Jus 1602.06)
Jus 1602.08 “Pharmaceutical
drug” means “pharmaceutical drug” as defined in RSA 318-E:1, I.
Source. #10177, eff 8-23-12;
ss by #13551, eff 2-2-23 (formerly Jus 1602.07)
Jus 1602.09 “Sharps” means needles, syringes, or lancets,
individually or collectively.
Source. #13551, eff 2-2-23
PART
Jus 1603 PERMANENT DROP BOXES
Jus
1603.01 Police Station Permanent Drop Boxes.
(a) The
chief law enforcement officer of an agency seeking to place a permanent drop
box in a police station shall first request and obtain written authorization, pursuant to 21 C.F.R. § 1317, from
the:
Drug Enforcement Administration – Office of Diversion Control
NEW ENGLAND DIVISION
JFK Federal Building
15 New Sudbury Street, Room E-400
Boston, MA 02203
(617) 557-2191
(b) A
permanent drop box shall only be located in a police station
and shall remain in the custody of law enforcement at all times.
(c) The
drop box shall be placed in a location that is accessible to the public and
under constant video recording surveillance.
(d) The
drop box shall be securely mounted to a wall or floor to prohibit removal of
the box or retrieval of the contents from within the box without a key.
(e) The
drop box shall be clearly marked with the following information:
“Pharmaceutical drugs, to include controlled,
non-controlled, and
over-the-counter drugs from households and residences only;
Pharmaceutical drugs may be disposed of in the
original containers or in a sealed plastic bag;
Liquid pharmaceuticals shall remain in the original
container; and
No needles, syringes, or lancets shall be placed in
the dropbox”.
(f) Individuals
shall place unused pharmaceutical drugs directly into the collection box.
(g)
Individuals utilizing the drop box in accordance with this chapter shall not be
questioned or required to disclose personal identification.
(h) The
chief law enforcement officer of an agency maintaining a permanent drop box
shall designate 2 law enforcement officers who shall be the sole possessors of
keys to the drop box. Each shall have a separate and distinct key,
with both keys required in order to access the drop
box.
(i) The designated law enforcement officers in
(h) above shall both be present when removing the contents of the drop box. In the event that one or both officers are unavailable to be
present when removing the contents of the drop box, the chief law enforcement
officer may designate one or more replacement officers to be present.
(j) The
contents of the drop box shall remain in a secured area of the law enforcement
agency until they are disposed of in accordance with the procedures outlined in
Jus 1605.
(k) The
chief law enforcement officer of an agency maintaining a permanent drop box
shall provide written notification to the attorney general that the agency has
established a program in accordance with these rules. The written
notification shall be sent to:
Department of Justice
Criminal Bureau
33 Capitol Street
Concord, NH 03301
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1603.02 Pharmaceutical Drugs Collected in Permanent Drop Box.
(a) Collected
pharmaceutical drugs shall remain secured until ready for disposal.
(b) An
inventory of collected pharmaceutical drugs shall not be required by these
rules.
(c) Collected
pharmaceutical drugs shall not be resold or reused.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
PART Jus 1604 PERIODIC OR ONE-TIME PHARMACEUTICAL
DRUG TAKE-BACK EVENTS
Jus
1604.01 Participation.
(a) A
pharmaceutical drug take-back collection event established by any government or
private entity, pursuant to RSA 318-E shall be voluntary.
(b) If
a government or private entity establishes a pharmaceutical drug take back collection
event, it shall be done in accordance with these rules and in conjunction with
a participating chief law enforcement officer of a law enforcement agency.
(c) The
chief law enforcement officer of the law enforcement agency seeking to
establish a collection event in conjunction with a government entity or private
entity, shall first request and obtain written authorization, pursuant to 21 C.F.R. § 1317, from
the:
Drug Enforcement
Administration – Office of Diversion Control
NEW ENGLAND DIVISION
JFK Federal Building
15
New Sudbury Street, Room E-400
Boston, MA 02203
(617) 557-2191
(d) The
chief law enforcement officer of a law enforcement agency establishing a
pharmaceutical drug take-back collection event in conjunction with a government
entity or private entity, shall provide written notification to the attorney
general that the agency has established an event in accordance with these
rules. Written notification shall be sent to:
Department of Justice
Criminal Bureau
33 Capitol Street
Concord, NH 03301
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1604.02 Standards and Procedures for the Collection Event.
(a) At
least 2 law enforcement officers designated by the chief law enforcement
officer of an agency participating in a collection event shall, at all times, be present and responsible for supervising the
collection event.
(b) The
law enforcement officers referred to in paragraph (a) shall, at
all times, have sole control over, and sole possession of, all
pharmaceutical drugs collected, and the collection box(es) in which the
collected pharmaceutical drugs are stored.
(c) Individuals
disposing of unused pharmaceutical drugs shall place them directly into the
collection box. Law enforcement officers shall not directly handle
the surrendered pharmaceutical drugs at any time.
(d) Individuals
utilizing the collection event in accordance with this chapter shall not be
questioned or required to disclose personal identification.
(e) Only
controlled and non-controlled pharmaceutical drugs, and over-the-counter drugs
from a household or residence shall be collected.
(f) No
sharps shall be placed in the collection box. A bulk sharps disposal container
may be provided at each collection event for the disposal of sharps.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1604.03 Removal of Collection Boxes.
(a) At
the conclusion of the collection event, law enforcement officers referred to in
Jus 1604.02(a) shall be responsible for removing the collection box(es) and
bulk sharps disposal container, if any, the same day from the event location
for disposal in accordance with the procedures outlined in Jus 1605.
(b) Collected
pharmaceutical drugs shall remain secured until ready for disposal.
(c) An
inventory of collected pharmaceutical drugs shall not
be required.
(d) Collected
pharmaceutical drugs shall not be resold or reused.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
PART Jus 1605 DISPOSAL OF PHARMACEUTICAL
DRUGS
Jus
1605.01 Procedure for Disposal of Pharmaceutical Drugs.
(a) Pharmaceutical
drugs collected pursuant to Jus 1603 or Jus 1604 shall be destroyed via
incineration at a solid waste disposal facility that is authorized to accept
the waste under the destination state's laws and rules.
(b) Pharmaceutical
drugs collected pursuant to Jus 1603 or Jus 1604 shall remain in a secured area
of the designated law enforcement area until the destruction of the material is
witnessed by a designated law enforcement officer.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1605.02 Documentation of Disposal of Pharmaceutical Drugs.
(a) The
designated law enforcement officer in Jus 1605.01(b) above shall document the
following:
(1) The date and location of the collection
event or location of the permanent drop box;
(2) The weight of the collected
pharmaceutical drugs;
(3) The date and location where the
collected pharmaceutical drugs were destroyed; and
(4) The name(s) of the designated
participating law enforcement officers, including the name of the law
enforcement officer that witnessed the destruction pursuant to Jus 1605.01 (b)
and either:
a. The names of the 2 law enforcement officers
identified under Jus 1604.02(a) for collection events;
or
b. The names of the 2 law enforcement officers
designated pursuant to Jus 1603.01(i) who are present
for the removal of the contents of a drop box, whichever is applicable.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
PART
Jus 1606 RECORDKEEPING
Jus
1606.01 Records.
(a) The
law enforcement agency participating in a program under Jus 1603 or Jus 1604
shall retain a copy of the documentation of the disposal of pharmaceutical
drugs, as required by Jus 1605, for a period not less than 5 years.
(b) Each
agency participating in a program under this chapter shall develop and maintain
a written manual of policies and procedures consistent with these rules.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
PART Jus
1607 WAIVERS
Jus
1607.01 Waiver Request.
(a)
The chief law enforcement officer of a law enforcement agency seeking to
establish a pharmaceutical drug take-back program in conjunction with a
government entity or private entity, may request a waiver of specific rules
outlined in this chapter in accordance with (c) below.
(b) The
chief law enforcement officer requesting a waiver shall submit the information
set forth in (c) in writing to the department at:
Department of Justice
Criminal Bureau
33 Capitol Street
Concord, NH 03301
(c) The
waiver request shall set forth the following information:
(1) A description of the pharmaceutical
drug take-back program to which the waiver request relates;
(2) A reference to the specific section of
the rules for which a waiver is being sought;
(3) A full and detailed explanation of why
a waiver is necessary;
(4) Whether the waiver is needed for a
limited duration and, if so, an estimate of when the waiver will no longer be needed;
(5) A full explanation with supporting data
of the alternatives, if any, proposed to be implemented or used in lieu of the
rule requirements; and
(6) A full explanation of how the waiver,
including any proposed alternatives:
a. Would be consistent with the intent of
RSA 318, RSA 318-B, and RSA
318-E; and
b. Would adequately protect human health and the
environment and prevent the illegal diversion of collected pharmaceutical
drugs.
Source. #10177, eff
8-23-12; ss by #13551, eff 2-2-23
Jus
1607.02 Incomplete Waiver Requests. Any waiver
request that is received by the department that does not conform with Jus 1607.01(c)
shall be deemed incomplete and returned to the requestor with an explanation.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
Jus
1607.03 Waiver Response.
(a) The
department shall issue a written response to a request for a waiver within 30
days of receiving a complete request. If the waiver is denied, the denial shall
specifically set forth the reason(s) for the denial.
(b) The
Department, in consultation with the Pharmacy Board, Department of Environmental
Services, and the department of Safety, shall grant a waiver if it
determines that the intent of RSA 318, 318-B, and 318-E will be met, human health and the environment will be
protected, and the illegal diversion of collected pharmaceutical drugs will be
prevented. In granting the waiver, the department shall impose such conditions,
including time limitations, as the department deems necessary to ensure that
the activities conducted pursuant to the waiver will be consistent with the
intent of RSA 318, 318-B, and
318-E.
(c) No
waiver shall be granted to any requirement specified in statute unless the
statute expressly allows such requirement to be waived.
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
PART
Jus 1608 PROCEDURES FOR WAIVERS FROM THE DEA
Jus
1608.01 Periodic or One-time Pharmaceutical Take-Back Collection Events.
(a) If
a government or private entity establishes a pharmaceutical drug-take-back collection
event, it shall be done in conjunction with a participating chief law
enforcement officer of a law enforcement agency.
(b) A
periodic or one-time pharmaceutical take-back collection event shall be exempt
from these rules if within 30 days before the scheduled event:
(1) The chief law enforcement officer
requests a written waiver from:
Drug Enforcement Administration-Office of Diversion
Control
NEW ENGLAND DIVISION
JFK Federal Building
15 New Sudbury Street, Room E-400
Boston, MA 02203
(617) 557-2191
(2) After receipt of the waiver from the
DEA, the chief law enforcement officer certifies in writing to the attorney
general that the periodic or one-time pharmaceutical take-back collection event
shall be compliant with the Northeast Recycling Council’s:
a. “Best
Management Practices Operating Unwanted Medication Collections – A Legal &
Safe Approach”, November 2008 edition;
b. “Holding an
Unwanted Medication Collection as Part of a Household Hazardous Waste Event – A
Legal and Safe Approach”, September 2006 edition; and
c. “Operating Unwanted
Medication Collections - A Legal & Safe Approach”, September 2006 edition.
(c) The
certification referred to in (b)(2) above, shall be signed by the chief law
enforcement officer and shall be sent to:
Department of Justice
Criminal Bureau
33 Capitol Street
Concord, NH 03301
Source. #10177, eff 8-23-12; ss by #13551, eff 2-2-23
APPENDIX
Rule |
Specific State and
Federal Statutes the Rule Implements |
|
|
Jus
1600 |
RSA
318-E:1 |
|
|
APPENDIX B
Rule |
Title |
Obtain at: |
Jus 1608.01 (b)(2) |
“Best Management Practices for Holding Unwanted Medication
Collections, A Legal & Safe Approach for Community Pharmacies, Northeast
Recycling Council, November 2008” “Holding an Unwanted Medication Collection
as Part of a Household Hazardous Waste Event – A Legal and Safe Approach,
Northeast Recycling Council, September 2006” “Operating Unwanted Medication
Collections – A Legal & Safe Approach, Northeast Recycling Council,
September 2006” |
https://nerc.org/documents/unwanted_medication_collection_bmp_11_08.pdf Price:
Free https://nerc.org/documents/holding_unwanted_medications_collection_final_2006.pdf Price:
Free https://nerc.org/documents/operating_unwanted_medication_collections_final_2006.pdf Price:
Free |