EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*hb0127*
HOUSE BILL 127
J1, J2 4lr0194
(PRE–FILED) CF SB 246
By: Chair, Health and Government Operations Committee (By Request –
Departmental – Health)
Requested: September 13, 2023
Introduced and read first time: January 10, 2024
Assigned to: Health and Government Operations
Committee Report: Favorable with amendments
House action: Adopted
Read second time: February 23, 2024
CHAPTER ______
AN ACT concerning 1
Public Health – Nonoccupational Postexposure Prophylaxis (nPEP) Standing 2
Order Program – Establishment 3
FOR the purpose of establishing the Nonoccupational Postexposure Prophylaxis (nPEP) 4
Standing Order Program to authorize pharmacists and health care providers to 5
prescribe or dispense nPEP under certain circumstances; authorizing the Maryland 6
Department of Health to administer the Program, collect fees necessary for the 7
administration of the Program, and establish guidelines for training related to the 8
Program; and generally relating to the Nonoccupational Postexposure Prophylaxis 9
(nPEP) Standing Order Program. 10
BY adding to 11
Article – Health – General 12
Section 13–5201 through 13–5205 13–5203 to be under the new subtitle “Subtitle 52. 13
Nonoccupational Postexposure Prophylaxis (nPEP) Standing Order Program” 14
Annotated Code of Maryland 15
(2023 Replacement Volume) 16
BY repealing and reenacting, without amendments, 17
Article – Health Occupations 18
Section 12–101(a) 19
Annotated Code of Maryland 20
(2021 Replacement Volume and 2023 Supplement) 21 2 HOUSE BILL 127
BY repealing and reenacting, with amendments, 1
Article – Health Occupations 2
Section 12–101(x) 3
Annotated Code of Maryland 4
(2021 Replacement Volume and 2023 Supplement) 5
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MA RYLAND, 6
That the Laws of Maryland read as follows: 7
Article – Health – General 8
SUBTITLE 52. NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS (NPEP) 9
STANDING ORDER PROGRAM. 10
13–5201. 11
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 12
INDICATED. 13
(B) “BOARD” MEANS THE STATE BOARD OF PHARMACY. 14
(C) “CDC GUIDELINES” MEANS THE “UPDATED GUIDELINES FOR 15
ANTIRETROVIRAL POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION 16
DRUG USE, OR OTHER NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES 17
2016” OR ANY SUBSEQUENT GU IDELINES PUBLISHED BY THE CENTERS FOR 18
DISEASE CONTROL AND PREVENTION. 19
(D) “NONOCCUPATIONAL POSTE XPOSURE PROPHYLAXIS ” OR “NPEP” 20
MEANS MEDICATION USE D IN ACCORDANCE WITH THE MOST RECENT CDC 21
GUIDELINES TO REDUCE THE CHANCES OF A PAT IENT DEVELOPING HIV AFTER 22
POTENTIAL EXPOSURE T O THE DISEASE. 23
(E) “PHARMACIST” MEANS A PHARMACIST L ICENSED IN THE STATE UNDER 24
TITLE 12 OF THE HEALTH OCCUPATIONS ARTICLE. 25
(F) “PRIVATE OR PUBLIC ENT ITY” MEANS A HEALTH CARE PROVIDER, 26
LOCAL HEALTH DEPARTM ENT, COMMUNITY –BASED ORGANIZATION , OR OTHER 27
PERSON THAT ADDRESSE S MEDICAL OR SOCIAL ISSUES RELATED TO HIV 28
EXPOSURE. 29
(G) (F) “PROGRAM” MEANS THE NONOCCUPATIONAL POSTEXPOSURE 30
PROPHYLAXIS (NPEP) STANDING ORDER PROGRAM. 31
HOUSE BILL 127 3
(H) (G) “STANDING ORDER ” MEANS A DIRECTIVE AU THORIZING 1
PHARMACISTS AND HEALTH CARE PROV IDERS TO DISPENSE THE N PEP REGIMENS 2
LISTED IN THE ORDER WITHOUT A PRESCRIPTI ON. 3
13–5202. 4
(A) THERE IS A NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS 5
(NPEP) STANDING ORDER PROGRAM. 6
(B) THE PROGRAM SHALL : 7
(1) AUTHORIZE A PHARMACIS T WHO IS REGISTERED WITH THE 8
PROGRAM TO DISPENSE N PEP THROUGH A STANDING O RDER IN ACCORDANCE 9
WITH § 13–5203 OF THIS SUBTITLE; AND 10
(2) AUTHORIZE A LICENSED HEALTH CARE PROVIDER WITH 11
PRESCRIBING AUTHORIT Y TO PRESCRIBE AND D ISPENSE NPEP THROUGH A 12
STANDING ORDER IN AC CORDANCE WITH § 13–5204 OF THIS SUBTITLE ; AND 13
(3) OPERATE IN ACCORDANCE WITH THE PROCEDURES APPROVED BY 14
THE DEPARTMENT WITH THE A DVICE AND APPROVAL O F THE BOARD. 15
(C) THE DEPARTMENT SHALL ADOP T REGULATIONS NECESSARY: 16
(1) NECESSARY FOR THE ADMINISTRATI ON OF THE PROGRAM; AND 17
(2) THAT ADDRESS THE NEED S OF SPECIFIC POPULA TIONS 18
INCLUDING VICTIMS OF SEXUAL ASSAULT AND P EDIATRIC PATIENTS . 19
(D) THE DEPARTMENT MAY : 20
(1) COLLECT FEES NECESSAR Y FOR THE ADMINISTRA TION OF THE 21
PROGRAM, UNLESS THE PATIENT Q UALIFIES FOR NPEP THROUGH THE PROGRAM 22
FOR PREVENTING HIV INFECTION FOR RAPE VICTIMS ESTABLISHED U NDER § 23
11–1008 OF THE CRIMINAL PROCEDURE ARTICLE; 24
(2) ADMINISTER THE PROGRAM AND ESTABLISH A STANDARDIZED 25
SET OF GUIDELINES FO R PRIVATE AND PUBLIC E NTITIES PHARMACISTS 26
PARTICIPATING IN THE PROGRAM TO USE IN DEV ELOPING AND CONDUCTI NG 27
PATIENT EDUCATION AN D TRAINING ON NPEP THAT INCLUDES : 28
(I) AVOIDING EXPOSURE TO HIV; 29
4 HOUSE BILL 127
(II) RESPONDING TO EXPOSUR E TO HIV WITH THE 1
APPROPRIATE USE OF N PEP; 2
(III) ACCESS TO NPEP AND THE APPROPRIATE FOLLOW–UP 3
AFTER THE ADMINISTRA TION OF NPEP; AND 4
(IV) ENGAGEMENT IN ADDITIO NAL CARE INCLUDING : 5
1. ACCESS TO PRE –EXPOSURE PROPHYLAXIS (PREP); 6
AND 7
2. HARM REDUCTION PROGRA MS FOR PATIENTS WITH 8
CONTINUING RISK OF E XPOSURES; AND 9
(3) COLLECT AND REPORT DA TA ON THE OPERATION AND RESULTS 10
OF THE PROGRAM. 11
13–5203. 12
(A) AT THE TIME OF DISPEN SING NPEP, A PHARMACIST REG ISTERED WITH 13
THE PROGRAM SHALL : 14
(1) SCREEN THE PATIENT TO DETERMINE THAT HIV EXPOSURE 15
OCCURRED WITHIN 72 HOURS BEFORE THE DIS PENSING; 16
(2) DETERMINE WHETHER THE PATIENT MEETS CLINIC AL CRITERIA 17
CONSISTENT WITH THE MOST RECENT CDC GUIDELINES, INCLUDING THE: 18
(I) THE IDENTIFICATION OF AN Y CONTRAINDICATED 19
MEDICATIONS ; AND 20
(II) IF APPLICABLE, EXPOSURE AS THE RESU LT OF AN ALLEGED 21
RAPE OR SEXUAL OFFEN SE OR ALLEGED CHILD SEXUAL ABUSE ; 22
(3) SUBJECT TO SUBSECTION (B) OF THIS SECTION , DETERMINE 23
WHETHER AN AVAILABLE STANDING ORDER IS AP PROPRIATE FOR THE PA TIENT AND 24
DISPENSE NPEP IN ACCORDANCE WITH THE MOST RECENT CDC GUIDELINES; 25
(4) REFER THE PATIENT TO A DISEASE INTERVENTI ON SPECIALIST 26
WITHIN THE DEPARTMENT FOR ONGOIN G TREATMENT ; AND 27
(5) DETERMINE WHETHER THE PATIENT HAS A PRIMAR Y CARE 28
PROVIDER AND : 29
HOUSE BILL 127 5
(I) IF THE PATIENT HAS A PRIMARY CARE PROVIDE R, NOTIFY 1
THE PROVIDER THAT TH E PATIENT WAS DISPEN SED NPEP; OR 2
(II) IF THE PATIENT DOES N OT HAVE A PRIMARY CA RE 3
PROVIDER, PROVIDE THE PATIENT WITH A LIST OF LOCAL PRIMARY CARE 4
PROVIDERS AND CLINIC S PROVIDED BY THE DEPARTMENT . 5
(B) IF AN AVAILABLE STAND ING ORDER IS NOT APP ROPRIATE FOR THE 6
PATIENT, THE PHARMACIST SHALL REFER THE PATIENT TO A P RIMARY CARE 7
PROVIDER. 8
(C) A PHARMACIST MAY DISPE NSE NPEP IN ACCORDANCE WITH A THERAPY 9
MANAGEMENT CONTRACT UNDER TITLE 12, SUBTITLE 6A OF THE HEALTH 10
OCCUPATIONS ARTICLE. 11
13–5204. 12
(A) A LICENSED HEALTH CARE PROVIDER WITH PRESCR IBING AUTHORITY 13
WHO IS REGISTERED WI TH THE PROGRAM MAY DELEGATE THE DISPENSING OF 14
NPEP UNDER A STANDING ORD ER TO AN EMPLOYEE OR A VOLUNTEER OF AN 15
AUTHORIZED PRIVATE O R PUBLIC ENTITY IN A CCORDANCE WITH A WRI TTEN 16
AGREEMENT UNDER § 13–5205 OF THIS SUBTITLE. 17
(B) ANY LICENSED HEALTH C ARE PROVIDER WHO HAS DISPENSING 18
AUTHORITY MAY DISPEN SE NPEP TO AN INDIVIDUAL IN ACCORDANCE WITH A 19
STANDING ORDER IN AC CORDANCE WITH THIS S UBSECTION. 20
13–5205. 21
AN AUTHORIZED PRIVATE OR PUBLIC ENTITY SHA LL ENTER INTO A WRIT TEN 22
AGREEMEN T WITH A LICENSED HE ALTH CARE PROVIDER W ITH PRESCRIBING 23
AUTHORITY TO ESTABLI SH PROTOCOLS FOR THE PRESCRIBING AND DISP ENSING OF 24
NPEP TO ANY INDIVIDUAL IN ACCORDANCE WITH THIS SUBTITLE. 25
Article – Health Occupations 26
12–101. 27
(a) In this title the following words have the meanings indicated. 28
(x) (1) “Practice pharmacy” means to engage in any of the following activities: 29
(i) Providing pharmaceutical care; 30
6 HOUSE BILL 127
(ii) Compounding, dispensing, or distributing prescription drugs or 1
devices; 2
(iii) Compounding or dispensing nonprescription drugs or devices; 3
(iv) Monitoring prescriptions for prescription and nonprescription 4
drugs or devices; 5
(v) Providing information, explanation, or recommendations to 6
patients and health care practitioners about the safe and effective use of prescription or 7
nonprescription drugs or devices; 8
(vi) Identifying and appraising problems concerning the use or 9
monitoring of therapy with drugs or devices; 10
(vii) Acting within the parameters of a therapy management contract, 11
as provided under Subtitle 6A of this title; 12
(viii) Administering vaccinations in accordance with § 12–508 of this 13
title or self–administered drugs or maintenance injectable medications in accordance with 14
§ 12–509 of this title; 15
(ix) Delegating a pharmacy act to a registered pharmacy technician, 16
pharmacy student, or an individual engaged in a Board approved pharmacy technician 17
training program; 18
(x) Supervising a delegated pharmacy act performed by a registered 19
pharmacy technician, pharmacy student, or an individual engaged in a Board approved 20
pharmacy technician training program; 21
(xi) Providing drug therapy management in accordance with § 22
19–713.6 of the Health – General Article; 23
(xii) Prescribing and dispensing contraceptive medications and 24
self–administered contraceptive devices approved by the U.S. Food and Drug 25
Administration; [or] 26
(xiii) Prescribing and dispensing nicotine replacement therapy 27
medications; OR 28
(XIV) IF THE PHARMACIST IS REGISTERED WITH THE 29
NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS (NPEP) STANDING ORDER 30
PROGRAM ESTABLISHED U NDER § 13–5202 OF THE HEALTH – GENERAL ARTICLE, 31
PRESCRIBING AND DISPENSING NONOCCUPA TIONAL POSTEXPOSURE PROPHYLAXIS 32
(NPEP) MEDICATION APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION 33
AND IN ACCORDANCE WI TH “UPDATED GUIDELINES FOR ANTIRETROVIRAL 34 HOUSE BILL 127 7
POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION DRUG USE, OR OTHER 1
NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES 2016” OR SUBSEQUENT 2
GUIDELINES PUBLISHED BY THE FEDERAL CENTERS FOR DISEASE CONTROL AND 3
PREVENTION. 4
(2) “Practice pharmacy” does not include the operations of a person who 5
holds a permit issued under § 12–6C–03 of this title. 6
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 7
October 1, 2024. 8
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.