WES MOORE, Governor Ch. 753
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Chapter 753
(House Bill 127)
AN ACT concerning
Public Health – Nonoccupational Postexposure Prophylaxis (nPEP) Standing
Order Program – Establishment
FOR the purpose of establishing the Nonoccupational Postexposure Prophylaxis (nPEP)
Standing Order Program to authorize pharmacists and health care providers to
prescribe or dispense nPEP under certain circumstances; authorizing the Maryland
Department of Health to administer the Program, collect fees necessary for the
administration of the Program, and establish guidelines for training related to the
Program; and generally relating to the Nonoccupational Postexposure Prophylaxis
(nPEP) Standing Order Program.
BY adding to
Article – Health – General
Section 13–5201 through 13–5205 13–5203 to be under the new subtitle “Subtitle 52.
Nonoccupational Postexposure Prophylaxis (nPEP) Standing Order Program”
Annotated Code of Maryland
(2023 Replacement Volume)
BY repealing and reenacting, without amendments,
Article – Health Occupations
Section 12–101(a)
Annotated Code of Maryland
(2021 Replacement Volume and 2023 Supplement)
BY repealing and reenacting, with amendments,
Article – Health Occupations
Section 12–101(x)
Annotated Code of Maryland
(2021 Replacement Volume and 2023 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Health – General
SUBTITLE 52. NONOCCUPAT IONAL POSTEXPOSURE PROPHYLAXIS (NPEP)
STANDING ORDER PROGRAM.
13–5201.
Ch. 753 2024 LAWS OF MARYLAND
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(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS
INDICATED.
(B) “BOARD” MEANS THE STATE BOARD OF PHARMACY.
(C) “CDC GUIDELINES” MEANS THE “UPDATED GUIDELINES FOR
ANTIRETROVIRAL POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION
DRUG USE, OR OTHER NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES
2016” OR ANY SUBSEQUENT GU IDELINES PUBLISHED B Y THE CENTERS FOR
DISEASE CONTROL AND PREVENTION.
(D) “NONOCCUPATIONAL POSTE XPOSURE PROPHYLAXIS ” OR “NPEP”
MEANS MEDICATION USE D IN ACCORDANCE WITH THE MOST RECENT CDC
GUIDELINES TO REDUCE THE CHANCES OF A PAT IENT DEVELOPING HIV AFTER
POTENTIAL EXPOSURE T O THE DISEASE.
(E) “PHARMACIST” MEANS A PHARMACIST L ICENSED IN THE STATE UNDER
TITLE 12 OF THE HEALTH OCCUPATIONS ARTICLE.
(F) “PRIVATE OR PUBLIC ENT ITY” MEANS A HEALTH CARE PROVIDER,
LOCAL HEALTH DEPARTM ENT, COMMUNITY –BASED ORGANIZATION , OR OTHER
PERSON THAT ADDRESSE S MEDICAL OR SOCIAL ISSUE S RELATED TO HIV
EXPOSURE.
(G) (F) “PROGRAM” MEANS THE NONOCCUPATIONAL POSTEXPOSURE
PROPHYLAXIS (NPEP) STANDING ORDER PROGRAM.
(H) (G) “STANDING ORDER ” MEANS A DIRECTIVE AU THORIZING
PHARMACISTS AND HEALTH CARE PROV IDERS TO DISPENSE THE N PEP REGIMENS
LISTED IN THE ORDER WITHOUT A PRESCRIPTI ON.
13–5202.
(A) THERE IS A NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS
(NPEP) STANDING ORDER PROGRAM.
(B) THE PROGRAM SHALL :
(1) AUTHORIZE A PHARMACIS T WHO IS REGISTERED WITH THE
PROGRAM TO DISPENSE N PEP THROUGH A STANDING O RDER IN ACCORDANCE
WITH § 13–5203 OF THIS SUBTITLE; AND
WES MOORE, Governor Ch. 753
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(2) AUTHORIZE A LICENSED HEALTH CARE PROVIDER WITH
PRESCRIBING AUTHORIT Y TO PRESCRIBE AND D ISPENSE NPEP THROUGH A
STANDING ORDER IN AC CORDANCE WITH § 13–5204 OF THIS SUBTITLE ; AND
(3) OPERATE IN ACCORDANCE WITH THE PROCEDURES APPROVED BY
THE DEPARTMENT WITH THE A DVICE AND APPROVAL O F THE BOARD.
(C) THE DEPARTMENT SHALL ADOP T REGULATIONS NECESSARY:
(1) NECESSARY FOR THE ADMINISTRATI ON OF THE PROGRAM; AND
(2) THAT ADDRESS THE NEED S OF SPECIFIC POPULA TIONS
INCLUDING VICTIMS OF SEXUAL ASSAULT AND P EDIATRIC PATIENTS .
(D) THE DEPARTMENT MAY :
(1) COLLECT FEES NECESSAR Y FOR THE ADMINISTRA TION OF THE
PROGRAM, UNLESS THE PATIENT Q UALIFIES FOR NPEP THROUGH THE PROGRAM
FOR PREVENTING HIV INFECTION FOR RAPE VICTIMS ESTABLISHED U NDER §
11–1008 OF THE CRIMINAL PROCEDURE ARTICLE;
(2) ADMINISTER THE PROGRAM AND ESTABLISH A STANDARDIZED
SET OF GUIDELINES FO R PRIVATE AND PUBLIC E NTITIES PHARMACISTS
PARTICIPATING IN THE PROGRAM TO USE IN DEV ELOPING AND CONDUCTI NG
PATIENT EDUCATION AN D TRAINING ON NPEP THAT INCLUDES :
(I) AVOIDING EXPOSURE TO HIV;
(II) RESPONDING TO EXPOSUR E TO HIV WITH THE
APPROPRIATE USE OF N PEP;
(III) ACCESS TO NPEP AND THE APPROPRIATE FOLLO W–UP
AFTER THE ADMINISTRA TION OF NPEP; AND
(IV) ENGAGEMENT IN ADDITIO NAL CARE INCLUDING :
1. ACCESS TO PRE –EXPOSURE PROPHYLAXIS (PREP);
AND
2. HARM REDUCTION PROGRA MS FOR PATIENTS WITH
CONTINUING RISK OF E XPOSURES; AND
(3) COLLECT AND REPORT DA TA ON THE OPERATION AND RESULTS
OF THE PROGRAM. Ch. 753 2024 LAWS OF MARYLAND
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13–5203.
(A) AT THE TIME OF DISPEN SING NPEP, A PHARMACIST REGISTE RED WITH
THE PROGRAM SHALL :
(1) SCREEN THE PATIENT TO DETERMINE THAT HIV EXPOSURE
OCCURRED WITHIN 72 HOURS BEFORE THE DISPENSING ;
(2) DETERMINE WHETHER THE PATIENT MEETS CLINIC AL CRITERIA
CONSISTENT WITH THE MOST RECENT CDC GUIDELINES, INCLUDING THE:
(I) THE IDENTIFICATION OF AN Y CONTRAINDICATED
MEDICATIONS ; AND
(II) IF APPLICABLE, EXPOSURE AS THE RESU LT OF AN ALLEGED
RAPE OR SEXUAL OFFEN SE OR ALLEGED CHILD SEXUAL ABUSE ;
(3) SUBJECT TO SUBSECTION (B) OF THIS SECTION , DETERMINE
WHETHER AN AVAILABLE STANDING ORDER IS AP PROPRIATE FOR THE PA TIENT AND
DISPENSE NPEP IN ACCORDANCE WITH THE MOST RECENT CDC GUIDELINES;
(4) REFER THE PATIENT TO A DISEASE INTERVENTI ON SPECIALIST
WITHIN THE DEPARTMENT FOR ONGOIN G TREATMENT ; AND
(5) DETERMINE WHETHER THE PATIENT HAS A PRIMAR Y CARE
PROVIDER AND :
(I) IF THE PATIENT HAS A PRIMARY CARE PROVIDE R, NOTIFY
THE PROVIDER THAT THE PA TIENT WAS DISPENSED NPEP; OR
(II) IF THE PATIENT DOES N OT HAVE A PRIMARY CA RE
PROVIDER, PROVIDE THE PATIENT WITH A LIST OF LOCAL PRIMARY CARE
PROVIDERS AND CLINIC S PROVIDED BY THE DEPARTMENT .
(B) IF AN AVAILABLE STAND ING ORDER IS NOT APPROPRIATE FOR THE
PATIENT, THE PHARMACIST SHALL REFER THE PATIENT TO A PRIMARY CARE
PROVIDER.
(C) A PHARMACIST MAY DISPE NSE NPEP IN ACCORDANCE WITH A THERAPY
MANAGEMENT CONTRACT UNDER TITLE 12, SUBTITLE 6A OF THE HEALTH
OCCUPATIONS ARTICLE.
13–5204. WES MOORE, Governor Ch. 753
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(A) A LICENSED HEALTH CARE PROVIDER WITH PRESCR IBING AUTHORITY
WHO IS REGISTERED WI TH THE PROGRAM MAY DELEGATE THE DISPENSING OF
NPEP UNDER A STANDING ORD ER TO AN EMPLOYEE OR A VOLUNTEER OF AN
AUTHORIZED PRIVATE O R PUBLIC ENTITY IN A CCORDANCE WITH A WRITTEN
AGREEMENT UNDER § 13–5205 OF THIS SUBTITLE.
(B) ANY LICENSED HEALTH C ARE PROVIDER WHO HAS DISPENSING
AUTHORITY MAY DISPEN SE NPEP TO AN INDIVIDUAL IN ACCORDANCE WITH A
STANDING ORDER IN AC CORDANCE WITH THIS S UBSECTION.
13–5205.
AN AUTHORIZED PR IVATE OR PUBLIC ENTI TY SHALL ENTER INTO A WRITTEN
AGREEMENT WITH A LIC ENSED HEALTH CARE PR OVIDER WITH PRESCRIB ING
AUTHORITY TO ESTABLI SH PROTOCOLS FOR THE PRESCRIBING AND DISP ENSING OF
NPEP TO ANY INDIVIDUAL IN ACCORDANCE WITH THIS SUBTITLE.
Article – Health Occupations
12–101.
(a) In this title the following words have the meanings indicated.
(x) (1) “Practice pharmacy” means to engage in any of the following activities:
(i) Providing pharmaceutical care;
(ii) Compounding, dispensing, or distributing prescription drugs or
devices;
(iii) Compounding or dispensing nonprescription drugs or devices;
(iv) Monitoring prescriptions for prescription and nonprescription
drugs or devices;
(v) Providing information, explanation, or recommendations to
patients and health care practitioners about the safe and effective use of prescription or
nonprescription drugs or devices;
(vi) Identifying and appraising problems concerning the use or
monitoring of therapy with drugs or devices;
(vii) Acting within the parameters of a therapy management contract,
as provided under Subtitle 6A of this title; Ch. 753 2024 LAWS OF MARYLAND
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(viii) Administering vaccinations in accordance with § 12–508 of this
title or self–administered drugs or maintenance injectable medications in accordance with
§ 12–509 of this title;
(ix) Delegating a pharmacy act to a registered pharmacy technician,
pharmacy student, or an individual engaged in a Board approved pharmacy technician
training program;
(x) Supervising a delegated pharmacy act performed by a registered
pharmacy technician, pharmacy student, or an individual engaged in a Board approved
pharmacy technician training program;
(xi) Providing drug therapy management in accordance with §
19–713.6 of the Health – General Article;
(xii) Prescribing and dispensing contraceptive medications and
self–administered contraceptive devices approved by the U.S. Food and Drug
Administration; [or]
(xiii) Prescribing and dispensing nicotine replacement therapy
medications; OR
(XIV) IF THE PHARMACIST IS REGISTERED WITH THE
NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS (NPEP) STANDING ORDER
PROGRAM ESTABLISHED U NDER § 13–5202 OF THE HEALTH – GENERAL ARTICLE,
PRESCRIBING AND DISPENSING NONOCCUPA TIONAL POSTEXPOSURE PROPHYLAXIS
(NPEP) MEDICATION APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION
AND IN ACCORDANCE WI TH “UPDATED GUIDELINES FOR ANTIRETROVIRAL
POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION DRUG USE, OR OTHER
NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES 2016” OR SUBSEQUENT
GUIDELINES PUBLISHED BY THE FEDERAL CENTERS FOR DISEASE CONTROL AND
PREVENTION.
(2) “Practice pharmacy” does not include the operations of a person who
holds a permit issued under § 12–6C–03 of this title.
SECTION 2. AND BE IT FURTHER ENACTED, That t his Act shall take effect
October 1, 2024.
Approved by the Governor, May 16, 2024.