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. *hb0028* HOUSE BILL 28 J2, J1 2lr1062 HB 1594/20 – HRU (PRE–FILED) CF SB 62 By: Delegates Bhandari and R. Lewis Requested: October 29, 2021 Introduced and read first time: January 12, 2022 Assigned to: Health and Government Operations Committee Report: Favorable with amendments House action: Adopted Read second time: March 12, 2022 CHAPTER ______ AN ACT concerning 1 Pharmacists – Aids for the Cessation of Tobacco Product Use Nicotine 2 Replacement Therapy Medication 3 FOR the purpose of authorizing a pharmacist who meets the requirements of regulations 4 adopted by the State Board of Pharmacy to prescribe and dispense nicotine 5 replacement therapy medications approved by the U.S. Food and Drug 6 Administration as aids for the cessation of the use of tobacco products for the purpose 7 of aiding in tobacco cessation or smoking cessation; and generally relating to the 8 prescribing and dispensing of aids for the cessation of the use of tobacco products 9 nicotine replacement therapy medications. 10 BY repealing and reenacting, without amendments, 11 Article – Health Occupations 12 Section 12–101(a) and (b) 13 Annotated Code of Maryland 14 (2021 Replacement Volume) 15 BY adding to 16 Article – Health Occupations 17 Section 12–101(o–2) and 12–514 18 Annotated Code of Maryland 19 (2021 Replacement Volume) 20 BY repealing and reenacting, with amendments, 21 2 HOUSE BILL 28 Article – Health Occupations 1 Section 12–101(x) 2 Annotated Code of Maryland 3 (2021 Replacement Volume) 4 BY adding to 5 Article – Health Occupations 6 Section 12–514 7 Annotated Code of Maryland 8 (2021 Replacement Volume) 9 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 10 That the Laws of Maryland read as follows: 11 Article – Health Occupations 12 12–101. 13 (a) In this title the following words have the meanings indicated. 14 (b) “Authorized prescriber” means any licensed dentist, licensed dental hygienist 15 with prescriptive authority under § 4–206.4 of this article, licensed physician, licensed 16 podiatrist, licensed veterinarian, advanced practice nurse with prescriptive authority 17 under § 8–508 of this article, or other individual authorized by law to prescribe prescription 18 or nonprescription drugs or devices. 19 (O–2) “NICOTINE REPLACEMENT THERAPY MEDICATION” MEANS A DRUG OR 20 PRODUCT, REGARDLESS OF WHETHE R IT IS AVAILABLE OV ER THE COUNTER , THAT: 21 (1) DELIVERS SMALL DOSES OF NICOTINE TO AN IN DIVIDUAL; AND 22 (2) IS APPROVED BY THE FE DERAL FOOD AND DRUG 23 ADMINISTRATION FOR TH E SOLE PURPOSE OF AIDING IN TOBACCO CESSATION OR 24 SMOKING CESSATION . 25 (x) (1) “Practice pharmacy” means to engage in any of the following activities: 26 (i) Providing pharmaceutical care; 27 (ii) Compounding, dispensing, or distributing prescription drugs or 28 devices; 29 (iii) Compounding or dispensing nonprescription drugs or devices; 30 (iv) Monitoring prescriptions for prescription and nonprescription 31 drugs or devices; 32 HOUSE BILL 28 3 (v) Providing information, explanation, or recommendations to 1 patients and health care practitioners about the safe and effective use of prescription or 2 nonprescription drugs or devices; 3 (vi) Identifying and appraising problems concerning the use or 4 monitoring of therapy with drugs or devices; 5 (vii) Acting within the parameters of a therapy management contract, 6 as provided under Subtitle 6A of this title; 7 (viii) Administering vaccinations in accordance with § 12–508 of this 8 title or self–administered drugs or maintenance injectable medications in accordance with 9 § 12–509 of this title; 10 (ix) Delegating a pharmacy act to a registered pharmacy technician, 11 pharmacy student, or an individual engaged in a Board approved pharmacy technician 12 training program; 13 (x) Supervising a delegated pharmacy act performed by a registered 14 pharmacy technician, pharmacy student, or an individual engaged in a Board approved 15 pharmacy technician training program; 16 (xi) Providing drug therapy management in accordance with 17 § 19–713.6 of the Health – General Article; [or] 18 (xii) Prescribing and dispensing contraceptive medications and 19 self–administered contraceptive devices approved by the U.S. Food and Drug 20 Administration; OR 21 (XIII) PRESCRIBING AND DISPE NSING NICOTINE REPLA CEMENT 22 THERAPY MEDICATIONS APPROVED BY THE U.S. FOOD AND DRUG 23 ADMINISTRATION AS AN AID FOR THE CESSATIO N OF THE USE OF TOBA CCO 24 PRODUCTS. 25 (2) “Practice pharmacy” does not include the operations of a person who 26 holds a permit issued under § 12–6C–03 of this title. 27 12–514. 28 (A) A PHARMACIST WHO MEETS THE REQUIREMENTS OF THE REGULATIONS 29 ADOPTED UNDER THIS S ECTION MAY PRESCRIBE AND DISPENSE NICOTIN E 30 REPLACEMENT THERAPY MEDICATIONS APPROVED BY THE U.S. FOOD AND DRUG 31 ADMINISTRATION AS AN AID FOR THE CESSATIO N OF THE USE OF TOBA CCO 32 PRODUCTS. 33 4 HOUSE BILL 28 (B) (1) ON OR BEFORE SEPTEMBER 1, 2023, THE BOARD SHALL ADOPT 1 REGULATIONS ESTABLIS HING: 2 (I) STANDARD PROCEDURES T HAT A PHARMACIST SHA LL USE 3 TO: 4 1. PRESCRIBE AND DISPENS E TO A PATIENT THE 5 APPROPRIATE AID FOR THE CESSATIO N OF THE USE OF TOBA CCO PRODUCTS BY THE 6 PATIENT NICOTINE REPLACEMENT THERAPY MEDICATION ; AND 7 2. REFER THE PATIENT TO A PRIMARY CARE 8 PRACTITIONER FOR TRE ATMENT; AND 9 (II) THE CONDITIONS UNDER WHICH A PHARMACIST M AY 10 PRESCRIBE AND DISPEN SE AN AID FOR THE CESSA TION OF THE USE OF T OBACCO 11 PRODUCTS NICOTINE REPLACEMENT THERAPY MEDICATION . 12 (2) THE REGULATIONS SHALL REQUIRE A PHARMACIST TO: 13 (I) EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS 14 SUBSECTION, COMPLETE A TRAINING PROGRAM APPROVED BY THE BOARD FOR 15 PRESCRIBING AND DISP ENSING AIDS FOR THE CES SATION OF THE USE OF TOBACCO 16 PRODUCTS NICOTINE REPLACEMENT THERAPY MEDICATION ; 17 (II) FOLLOW THE STANDARD P ROCEDURES ESTABLISHE D BY 18 THE BOARD; AND 19 (III) AFTER PRESCRIBING AND DISPENSING TO A PATI ENT AN 20 AID FOR THE CESSATIO N OF THE USE OF TOBA CCO PRODUCTS NICOTINE 21 REPLACEMENT THERAPY MEDICATION: 22 1. REFER THE PATIENT FOR ANY ADDITIONAL CARE TO 23 THE PATIENT’S PRIMARY CARE PRACT ITIONER; 24 2. PROVIDE THE PATIENT W ITH: 25 A. A WRITTEN RECORD OF TH E NICOTINE 26 REPLACEMENT THERAPY MEDICATION DISPENSED; AND 27 B. INFORMATION ON THE IM PORTANCE OF THE PATI ENT 28 SEEING THE PATIENT ’S PRIMARY CARE PRACT ITIONER; AND 29 3. RECORD THE PRESCRIBIN G AND DISPENSING OF THE 30 AID FOR THE CESSATIO N OF THE USE OF TOBA CCO PRODUCTS NICOTINE 31 HOUSE BILL 28 5 REPLACEMENT THERAPY MEDICATION IN ANY ELECTRONIC HE ALTH RECORD 1 MAINTAINED FOR THE P ATIENT BY THE PHARMA CIST. 2 (3) THE REGULATIONS SHALL WAIVE THE REQUIREMEN T TO 3 COMPLETE THE TRAININ G PROGRAM UNDER PARA GRAPH (2)(I) OF THIS 4 SUBSECTION FOR A PHA RMACIST WHO ALREADY HAS UNDERGONE THE TRAINING AS 5 PART OF THE PHARMACI ST’S FORMAL EDUCATIONAL PROGRAM. 6 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 7 October 1, 2022. 8 Approved: ________________________________________________________________________________ Governor. ________________________________________________________________________________ Speaker of the House of Delegates. ________________________________________________________________________________ President of the Senate.