CHAPTER 152

HB 426 - FINAL VERSION

 

15Jun2023... 2186EBA

2023 SESSION

23-0315

09/05

 

HOUSE BILL 426

 

AN ACT relative to the regulation of pharmacists-in-charge and pharmacies.

 

SPONSORS: Rep. Rochefort, Graf. 1; Rep. Merchant, Sull. 6; Rep. C. McGuire, Merr. 27; Rep. Peternel, Carr. 6; Rep. Simon, Graf. 1

 

COMMITTEE: Commerce and Consumer Affairs

 

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ANALYSIS

 

This bill adjusts how pharmacy permit holders are defined.

 

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Explanation: Matter added to current law appears in bold italics.

Matter removed from current law appears [in brackets and struckthrough.]

Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

15Jun2023... 2186EBA 23-0315

09/05

 

STATE OF NEW HAMPSHIRE

 

In the Year of Our Lord Two Thousand Twenty Three

 

AN ACT relative to the regulation of pharmacists-in-charge and pharmacies.

 

Be it Enacted by the Senate and House of Representatives in General Court convened:

 

152:1  New Paragraph; Pharmacists and Pharmacies; Definitions; Permit Holder.  Amend RSA 318:1 by inserting after paragraph XXXVI the following new paragraph:

XXXVII.  "Permit holder" means the entity that owns or operates the pharmacy licensed to operate in the state and is responsible for the facility and overall operation of the pharmacy.

152:2 Pharmacists and Pharmacies; Disciplinary Action; References to Pharmacist-in-Charge Removed and Reference to Permit Holder Added.  Amend RSA 318:29 to read as follows:

318:29 Disciplinary Action.

I. The board may undertake disciplinary action against any licensee, [permittee], permit holder, registrant, or certificate holder:

(a) Upon its own initiative; or

(b) Upon written complaint of any person which alleges that a licensee, [permittee], permit holder registrant, or certificate holder has committed misconduct under paragraph II or V of this section or any other applicable provision of this chapter or RSA 318-B, and which specifies the grounds therefor.

II.  Misconduct by a permit holder sufficient to support disciplinary proceedings under this section shall include:

(a)  The practice of fraud or deceit in procuring or attempting to procure a [license], permit, [registration, or certificate to practice] under this chapter;

[(b)  Conviction of a felony or any offense involving moral turpitude;

(c)  Any dishonest or unprofessional conduct, or gross or repeated negligent conduct in the practice of pharmacy or in performing activities ancillary to the practice of pharmacy or any particular aspect or specialty thereof;

(d)  Behavior which demonstrates a clear conflict with the basic knowledge and competence expected of licensed pharmacists or any particular aspect or specialty of the practice of pharmacy, or any intentional act which demonstrates a clear inconsistency with the health and safety of persons making use of the professional services of any person licensed under this chapter;

(e)  Addiction to the use of alcohol or other habit-forming drugs to a degree which renders him or her unfit to practice under this chapter;

(f)  Mental or physical incompetency to practice under this chapter; or

(g)] (b) Willful or repeated violation of any provision of this chapter, any substantive rule of the board, or any other federal, state, or local drug or pharmacy-related law, rule, or regulation.

[(h)  [Repealed.]]

II-a  Misconduct by a licensee, registrant or certificate holder sufficient to support disciplinary proceedings under this section shall include:

(a)  The practice of fraud or deceit in procuring or attempting to procure a license, registration, or certificate to practice under this chapter;

(b)  Conviction of a felony or any offense involving moral turpitude;

(c)  Any dishonest or unprofessional conduct, or gross or repeated negligent conduct in the practice of pharmacy or in performing activities ancillary to the practice of pharmacy or any particular aspect or specialty thereof;

(d)  Behavior which demonstrates a clear conflict with the basic knowledge and competence expected of licensed pharmacists or any particular aspect or specialty of the practice of pharmacy, or any intentional act which demonstrates a clear inconsistency with the health and safety of persons making use of the professional services of any person licensed under this chapter;

(e)  Addiction to the use of alcohol or other habit-forming drugs to a degree which renders him or her unfit to practice under this chapter;

(f)  Mental or physical incompetency to practice under this chapter; or

(g)  Willful or repeated violation of any provision of this chapter, any substantive rule of the board, or any other federal, state, or local drug or pharmacy-related law, rule, or regulation.

III.  [Repealed.]

IV.  The board may take disciplinary action in any one or more of the following ways:

(a)  By reprimand;

(b)  By suspension, limitation or restriction of a license, permit, registration, or certification or probation for any period of time deemed reasonable by the board;

(c)  By revocation of license, permit, registration, or certification;

(d)  By assessing administrative fines in amounts established by the board;

(e)  By requiring the person, if a licensee, registrant, or certificate holder, to participate in a program of continuing education in the area or areas in which he or she has been found deficient; or

(f)  By requiring the person, if a licensee, registrant, or certificate holder, to submit to the care, observation or treatment of a physician, counseling service, health care facility, professional assistance program, or any comparable person or facility approved by the board.

V.  The board may, after notice and hearing, suspend or revoke a pharmacy permit, [license, or registration] for grounds which include, but are not limited to:

[(a)  The suspension, revocation, or expiration of the pharmacist license of the pharmacist-in-charge.

(b)  Termination of the employment of the pharmacist-in-charge with the pharmacy.

(c)] (a)  Operation of the pharmacy in a manner that is in violation of federal, state, or local drug or pharmacy-related law, rule, or regulation.

[(d)] (b)  Conviction of [the pharmacist-in-charge,] the permit holder, an owner, a corporate officer, the corporation, or the pharmacy of a felony, a misdemeanor resulting from a violation of any federal, state, or local drug or pharmacy-related law, rule or regulation, or an act involving moral turpitude or gross immorality.

[(e)] (c)  Unsanitary conditions.

[(f)] (d)  Fraud, intentional misrepresentation or perjury in securing the permit, license, or registration or in any hearing before the board.

[(g)] (e)  Unprofessional conduct which includes, but is not limited to, violations of federal, state, or local drug or pharmacy-related laws, rules, or regulations, or other acts or omissions which, in the opinion of the board, pose a threat to the well-being or the safety of the public.

[(h) Fee splitting for professional services.  This does not prohibit rent payments under a rental or lease agreement for the operation of a pharmacy by a pharmacist or pharmacy to an individual licensed to prescribe medicine.]

[(i)] (f)  Any ownership or control of an ownership interest of a pharmacy within the state by an individual licensed to prescribe medicine, or a corporation, professional association or partnership consisting of such prescriber or prescriber's immediate family members, except such corporations as are expressly exempt from income taxation under section 501(c)(3) of the United States Internal Revenue Code.  This shall not include ownership of investment securities purchased by the practitioner on terms available to the general public and which are publicly traded.  This subparagraph shall not apply to the ownership or control of an ownership interest of an institutional pharmacy operated within the state by or for hospitals, as defined in RSA 151:2, I(a), licensed by the state pursuant to RSA 151.

[(j)] (g)  The sale, rental, trade, transfer, or release of patient identifiable medical information for the purpose of sales or marketing of services or products without written authorization.

VI.  The board may, after notice and hearing, suspend, or revoke a license, registration or certificate for grounds which include but are not limited to:

(a)  Operation of the pharmacy in a manner that is in violation of federal, state, or local drug or pharmacy-related law, rule, or regulation.

(b)  Unsanitary conditions.

(c)  Fraud, intentional misrepresentation, or perjury in securing the license, registration, or certificate or in any hearing before the board.

(d)  Unprofessional conduct which includes, but is not limited to, violations of federal, state, or local drug or pharmacy-related laws, rules, or regulations, or other acts or omissions which, in the opinion of the board, pose a threat to the well-being or the safety of the public.

(e)  Fee splitting for professional services.  This does not prohibit rent payments under a rental or lease agreement for the operation of a pharmacy by a pharmacist or pharmacy to an individual licensed to prescribe medicine.

(f)  Any ownership or control of an ownership interest of a pharmacy within the state by an individual licensed to prescribe medicine, or a corporation, professional association or partnership consisting of such prescriber or prescriber's immediate family members, except such corporations as are expressly exempt from income taxation under section 501(c)(3) of the United States Internal Revenue Code.  This shall not include ownership of investment securities purchased by the practitioner on terms available to the general public and which are publicly traded.  This subparagraph shall not apply to the ownership or control of an ownership interest of an institutional pharmacy operated within the state by or for hospitals, as defined in RSA 151:2, I(a), licensed by the state pursuant to RSA 151.

(g)  The sale, rental, trade, transfer, or release of patient identifiable medical information for the purpose of sales or marketing of services or products without written authorization.

152:3  Permit; Fees.  Amend RSA 318:38, I to read as follows:

I.  The board shall, upon application and hearing, issue a permit to maintain and operate a pharmacy to such persons, firms, or corporations as they deem qualified to conduct a pharmacy.  The permit shall be issued to the [pharmacy] permit holder in the name of the corporation or the owner of the pharmacy.  This permit, to be known as a pharmacy permit, shall certify that the [designated pharmacist-in-charge] permit holder has accepted the responsibility for the safe, effective operation of a pharmacy and compliance with all pharmacy and drug laws or regulations; that the premises named in the permit are a fit place to practice pharmacy including, but not limited to, the compounding and dispensing of medicines upon prescriptions and for the manufacture, sale, and distribution of drugs, medicines, and poisons; and that such premises and acts shall be under the direct supervision of a licensed pharmacist.  The holder of a pharmacy permit may keep this pharmacy open at all hours for the compounding, dispensing, and sale of drugs and medicines provided that a pharmacist is present and on duty; except that in an institutional setting, in the absence of a pharmacist, a registered nurse, designated by the institution for this purpose, may enter and obtain from an institutional pharmacy such drugs as are needed in an emergency situation or as may otherwise be provided for in this chapter.  The applicant for a pharmacy permit or a renewal thereof shall provide the board with all information it deems necessary for determining the applicant's qualifications to own and operate a pharmacy in the public interest.

152:4  Continuous Quality Improvement.  Amend RSA 318:45-a, II and III to read as follows:

II.  A CQI program may be comprised of staff members of the [pharmacist] pharmacy, including pharmacists, registered pharmacist interns, licensed advanced pharmacy technicians, registered pharmacy technicians, clerical staff, and other personnel deemed necessary by the [pharmacist in charge] permit holder or the consultant pharmacist of record.

III.  A CQI program shall require that the [pharmacist in charge] permit holder or the consultant pharmacist of record ensure that a review of quality-related events occurs at least every 3 months, contain a planned process to record and assess quality related events, include a process for documenting actions to improve the quality of patient care, and maintain a summary of the documented actions. The review should consider environment and systems-based contributing factors.

152:5  Prescription Labels.  Amend RSA 318:47-a to read as follows:

318:47-a  Prescription Labels.  Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he or she shall affix to the container in which such drug is dispensed a label [showing at least the name and address of the pharmacy and the name or initials of the dispensing pharmacist or pharmacist-in-charge] that meets the requirements of the New Hampshire board of pharmacy; the prescription identification number assigned by the pharmacy; the date dispensed; any directions as may be stated on the prescription; the name of the prescribing practitioner; the name of the patient; all pertinent auxiliary labels; and, unless otherwise indicated by the prescribing physician, dentist, veterinarian, or advanced practice registered nurse, the name, strength, and quantity of the drug dispensed.  All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities.  A biological product, as defined in RSA 318:47-dd, I, shall also be labeled as provided in RSA 318:47-dd, VII.  No person shall alter, deface, or remove any label so affixed.  A compounded drug product shall also be labeled as provided in RSA 318:14-a, II.  The compound drug product shall bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration, and the prescription shall be filed at that pharmacy.  Compounded prescription labels shall include the phrase "compounded per subscriber request" or a similar statement on the prescription label or through the use of an auxiliary label attached to the prescription container.

152:6  Repeal.  RSA 318:1, X, relative to pharmacists-in-charge, is repealed.

152:7  Effective Date.  This act shall take effect 60 days after its passage.

 

Approved: July 28, 2023

Effective Date: September 26, 2023