EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*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
A BILL ENTITLED
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 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
BY repealing and reenacting, with amendments, 22
Article – Health Occupations 23
Section 12–101(x) 24
Annotated Code of Maryland 25
(2021 Replacement Volume and 2023 Supplement) 26 2 HOUSE BILL 127
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
That the Laws of Maryland read as follows: 2
Article – Health – General 3
SUBTITLE 52. NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS (NPEP) 4
STANDING ORDER PROGRAM. 5
13–5201. 6
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 7
INDICATED. 8
(B) “BOARD” MEANS THE STATE BOARD OF PHARMACY. 9
(C) “CDC GUIDELINES” MEANS THE “UPDATED GUIDELINES FOR 10
ANTIRETROVIRAL POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION 11
DRUG USE, OR OTHER NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES 12
2016” OR ANY SUBSEQUENT GU IDELINES PUBLISHED B Y THE CENTERS FOR 13
DISEASE CONTROL AND PREVENTION. 14
(D) “NONOCCUPATIONAL POSTE XPOSURE PROPHYLAXIS ” OR “NPEP” 15
MEANS MEDICATION USE D IN ACCORDANCE WITH CDC GUIDELINES TO REDUCE 16
THE CHANCES OF A PAT IENT DEVELOPING HIV AFTER POTENTIAL EXPO SURE TO 17
THE DISEASE. 18
(E) “PHARMACIST” MEANS A PHARMACIST LICENSED IN THE STATE UNDER 19
TITLE 12 OF THE HEALTH OCCUPATIONS ARTICLE. 20
(F) “PRIVATE OR PUBLIC ENT ITY” MEANS A HEALTH CARE PROVIDER, 21
LOCAL HEALTH DEPARTM ENT, COMMUNITY –BASED ORGANIZATION , OR OTHER 22
PERSON THAT ADDRESSE S MEDICAL OR SOCIAL ISSUES RELATED TO HIV 23
EXPOSURE. 24
(G) “PROGRAM” MEANS THE NONOCCUPATIONAL POSTEXPOSURE 25
PROPHYLAXIS (NPEP) STANDING ORDER PROGRAM. 26
(H) “STANDING ORDER ” MEANS A DIRECTIVE AUTHORIZING PHARMACI STS 27
AND HEALTH CARE PROV IDERS TO DISPENSE TH E NPEP REGIMENS LISTED IN T HE 28
ORDER WITHOUT A PRES CRIPTION. 29
13–5202. 30
HOUSE BILL 127 3
(A) THERE IS A NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS 1
(NPEP) STANDING ORDER PROGRAM. 2
(B) THE PROGRAM SHALL : 3
(1) AUTHORIZE A PHARMACIS T WHO IS REGISTERED WITH THE 4
PROGRAM TO DISPENSE N PEP THROUGH A STANDIN G ORDER IN ACCORDANC E 5
WITH § 13–5203 OF THIS SUBTITLE; 6
(2) AUTHORIZE A LICENSED HEALTH CARE PROVIDER WITH 7
PRESCRIBING AUTHORIT Y TO PRESCRIBE AND D ISPENSE NPEP THROUGH A 8
STANDING ORDER IN AC CORDANCE WITH § 13–5204 OF THIS SUBTITLE ; AND 9
(3) OPERATE IN ACCORDANCE WITH THE PROCEDURES APPROVED BY 10
THE DEPARTMENT WITH THE A DVICE AND APPROVAL O F THE BOARD. 11
(C) THE DEPARTMENT SHALL ADOP T REGULATIONS NECESS ARY FOR THE 12
ADMINISTRATION OF TH E PROGRAM. 13
(D) THE DEPARTMENT MAY : 14
(1) COLLECT FEES NECESSAR Y FOR THE ADMINISTRATION OF THE 15
PROGRAM; 16
(2) ADMINISTER THE PROGRAM AND ESTABLISH A STANDARDIZED 17
SET OF GUIDELINES FO R PRIVATE AND PUBLIC ENTITIES PARTICIPATI NG IN THE 18
PROGRAM TO USE IN DEV ELOPING AND CONDUCTI NG PATIENT EDUCATION AND 19
TRAINING ON NPEP THAT INCLUDES: 20
(I) AVOIDING EXPOSURE TO HIV; 21
(II) RESPONDING TO EXPOSUR E TO HIV WITH THE 22
APPROPRIATE USE OF N PEP; 23
(III) ACCESS TO NPEP AND THE APPROPRIATE FOLLOW–UP 24
AFTER THE ADMINISTRA TION OF NPEP; AND 25
(IV) ENGAGEMENT IN ADDITIO NAL CARE INCLUDING : 26
1. ACCESS TO PRE –EXPOSURE PROPHYLAXIS (PREP); 27
AND 28
4 HOUSE BILL 127
2. HARM REDUCTION PROGRA MS FOR PATIENTS WITH 1
CONTINUING RISK OF E XPOSURES; AND 2
(3) COLLECT AND REPORT DA TA ON THE OPERATION AND RESULTS 3
OF THE PROGRAM. 4
13–5203. 5
(A) AT THE TIME OF DISPEN SING NPEP, A PHARMACIST REGISTE RED WITH 6
THE PROGRAM SHALL : 7
(1) SCREEN THE PATIENT TO DETERMINE THAT HIV EXPOSURE 8
OCCURRED WITHIN 72 HOURS BEFORE THE DIS PENSING; 9
(2) DETERMINE WHETHER THE PATIENT MEETS CLINIC AL CRITERIA 10
CONSISTENT WITH CDC GUIDELINES, INCLUDING THE IDENTI FICATION OF ANY 11
CONTRAINDICATED MEDI CATIONS; 12
(3) SUBJECT TO SUBSECTION (B) OF THIS SECTION , DETERMINE 13
WHETHER AN AVAILABLE STANDING ORDER IS AP PROPRIATE FOR THE PA TIENT AND 14
DISPENSE NPEP IN ACCORDANCE WITH CDC GUIDELINES; 15
(4) REFER THE PATIENT TO A DISEASE INTERVENTION SPECIALIST 16
WITHIN THE DEPARTMENT FOR ONGOIN G TREATMENT ; AND 17
(5) DETERMINE WHETHER THE PATIENT HAS A PRIMAR Y CARE 18
PROVIDER AND : 19
(I) IF THE PATIENT HAS A PRIMARY CARE PROVIDE R, NOTIFY 20
THE PROVIDER THAT TH E PATIENT WAS DISPENSED N PEP; OR 21
(II) IF THE PATIENT DOES N OT HAVE A PRIMARY CA RE 22
PROVIDER, PROVIDE THE PATIENT WITH A LIST OF PRIMA RY CARE PROVIDERS AN D 23
CLINICS. 24
(B) IF AN AVAILABLE STAND ING ORDER IS NOT APP ROPRIATE FOR THE 25
PATIENT, THE PHARMACIST SHALL REFER THE PATIENT TO A PRIMARY CARE 26
PROVIDER. 27
(C) A PHARMACIST MAY DISPE NSE NPEP IN ACCORDANCE WITH A THERAPY 28
MANAGEMENT CONTRACT UNDER TITLE 12, SUBTITLE 6A OF THE HEALTH 29
OCCUPATIONS ARTICLE. 30
HOUSE BILL 127 5
13–5204. 1
(A) A LICENSED HEALTH CARE PROVIDER WITH PRESCR IBING AUTHORITY 2
WHO IS REGISTERED WI TH THE PROGRAM MAY DELEGATE THE DISPENSING OF 3
NPEP UNDER A STANDING ORD ER TO AN EMPLOYEE OR A VOLUNTEER OF AN 4
AUTHORIZED PRIVATE O R PUBLIC ENTITY IN A CCORDANCE WITH A WRI TTEN 5
AGREEMENT UNDER § 13–5205 OF THIS SUBTITLE. 6
(B) ANY LICENSED HEALTH C ARE PROVIDER WHO HAS DISPENSING 7
AUTHORITY MAY DISPEN SE NPEP TO AN INDIVIDUAL IN ACCORDANCE WITH A 8
STANDING ORDER IN AC CORDANCE WITH THIS S UBSECTION. 9
13–5205. 10
AN AUTHORIZED PRIVATE OR PUBLIC ENTITY SHA LL ENTER INTO A WRIT TEN 11
AGREEMENT WITH A LIC ENSED HEALTH CARE PR OVIDER WITH PRESCRIB ING 12
AUTHORITY TO ESTABLI SH PROTOCOLS FOR THE PRESCRIBING AND DISP ENSING OF 13
NPEP TO ANY INDIVIDUAL IN ACCORDANCE WITH THIS SUBTITLE. 14
Article – Health Occupations 15
12–101. 16
(a) In this title the following words have the meanings indicated. 17
(x) (1) “Practice pharmacy” means to engage in any of the following activities: 18
(i) Providing pharmaceutical care; 19
(ii) Compounding, dispensing, or distributing prescription drugs or 20
devices; 21
(iii) Compounding or dispensing nonprescription drugs or devices; 22
(iv) Monitoring prescriptions for prescription and nonprescription 23
drugs or devices; 24
(v) Providing information, explanation, or recommendations to 25
patients and health care practitioners about the safe and effective use of prescription or 26
nonprescription drugs or devices; 27
(vi) Identifying and appraising problems concerning the use or 28
monitoring of therapy with drugs or devices; 29
6 HOUSE BILL 127
(vii) Acting within the parameters of a therapy management contract, 1
as provided under Subtitle 6A of this title; 2
(viii) Administering vaccinations in accordance with § 12–508 of this 3
title or self–administered drugs or maintenance injectable medications in accordance with 4
§ 12–509 of this title; 5
(ix) Delegating a pharmacy act to a registered pharmacy technician, 6
pharmacy student, or an individual engaged in a Board approved pharmacy technician 7
training program; 8
(x) Supervising a delegated pharmacy act performed by a registered 9
pharmacy technician, pharmacy student, or an individual engaged in a Board approved 10
pharmacy technician training program; 11
(xi) Providing drug therapy management in accordance with § 12
19–713.6 of the Health – General Article; 13
(xii) Prescribing and dispensing contraceptive medications and 14
self–administered contraceptive devices approved by the U.S. Food and Drug 15
Administration; [or] 16
(xiii) Prescribing and dispensing nicotine replacement therapy 17
medications; OR 18
(XIV) IF THE PH ARMACIST IS REGISTER ED WITH THE 19
NONOCCUPATIONAL POSTEXPOSURE PROPHYLAXIS (NPEP) STANDING ORDER 20
PROGRAM ESTABLISHED U NDER § 13–5202 OF THE HEALTH – GENERAL ARTICLE, 21
PRESCRIBING AND DISP ENSING NONOCCUPATION AL POSTEXPOSURE PROP HYLAXIS 22
(NPEP) MEDICATION APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION 23
AND IN ACCORDANCE WI TH “UPDATED GUIDELINES FOR ANTIRETROVIRAL 24
POSTEXPOSURE PROPHYLAXIS AFTER SEXUAL, INJECTION DRUG USE, OR OTHER 25
NONOCCUPATIONAL EXPOSURE TO HIV – UNITED STATES 2016” OR SUBSEQUENT 26
GUIDELINES PUBLISHED BY THE FEDERAL CENTERS FOR DISEASE CONTROL AND 27
PREVENTION. 28
(2) “Practice pharmacy” does not include the operations of a person who 29
holds a permit issued under § 12–6C–03 of this title. 30
SECTION 2. AND BE IT FURTHER ENACTED, That this Act s hall take effect 31
October 1, 2024. 32