An Act relative to medical sharps stewardship

1 of 1 HOUSE DOCKET, NO. 3144 FILED ON: 1/16/2025 HOUSE . . . . . . . . . . . . . . . No. 2417 The Commonwealth of Massachusetts _________________ PRESENTED BY: Carole A. Fiola _________________ To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General Court assembled: The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: An Act relative to medical sharps stewardship. _______________ PETITION OF: NAME: DISTRICT/ADDRESS: DATE ADDED: Carole A. Fiola 6th Bristol 1/16/2025 1 of 4 HOUSE DOCKET, NO. 3144 FILED ON: 1/16/2025 HOUSE . . . . . . . . . . . . . . . No. 2417 By Representative Fiola of Fall River, a petition (accompanied by bill, House, No. 2417) of Carole A. Fiola relative to medical sharps stewardship. Public Health. The Commonwealth of Massachusetts _______________ In the One Hundred and Ninety-Fourth General Court (2025-2026) _______________ An Act relative to medical sharps stewardship. Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows: 1 SECTION 1. Section 1 of chapter 94H of the General Laws, as appearing in the 2022 2 Official Edition, is hereby amended by striking out the second paragraph and inserting in place 3 thereof the following paragraph:- 4 “Covered drug”, any brand name or generic opioid drug placed in Schedule II or 5 Schedule III of section 3 of chapter 94C; provided, however, that “covered drug” shall also 6 include “(i) benzodiazepines, and (ii) sharps subject to collection and disposal procedures 7 established in section 27A of chapter 94C; provided, further, that “covered drug” shall not 8 include (i) drugs intended for use solely in veterinary care; (ii) substances that are regulated as 9 cosmetic products under the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq; 10 (iii) drugs that are compound under a specialty license pursuant to sections 39G to 39J, inclusive, 11 of chapter 112; or (iv) drugs approved and used primarily for medication-assisted substance use 12 disorder treatment. 2 of 4 13 SECTION 2. Said section 1 of chapter 94H, is hereby further amended by inserting the 14 following definition:- 15 “Sharps”, objects with sharp points or edges that can puncture or cut skin, which shall 16 include but are not limited to hypodermic needles, syringes, lancets, auto injectors, infusion sets, 17 and connection needles. 18 SECTION 3. Said section 1 of chapter 94H, is hereby further amended by inserting the 19 following definition:- 20 “Sharps disposal containers”, containers made from rigid puncture-resistant plastic or 21 metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an 22 opening to accommodate depositing a sharp but not large enough for a hand to enter. 23 SECTION 4. Section 3 of chapter 94H, as so appearing, is hereby amended by striking 24 out the section in its entirety and inserting in place thereof the following section:- 25 Section 3. A manufacturer or stewardship organization seeking approval for a drug 26 stewardship program shall submit, in a manner and form determined by the department, a plan 27 that meets, but is not limited to, the following requirements: 28 (i) for all covered drugs not including sharps, a collection system to provide convenient, 29 ongoing collection services to all persons seeking to dispose of unwanted drugs; provided, 30 however, that the collection system may accept any covered drug and any other prescription drug 31 in a pill formulation regardless of its schedule, brand or source of manufacture; provided further, 32 that the collection system shall include 2 methods as recommended by the department, which 33 may include, but not be limited to: (A) a mail-back program that provides prepaid and 3 of 4 34 preaddressed packaging for a pharmacy to distribute when filling a prescription for a covered 35 drug or upon request by a consumer; (B) collection kiosks; (C) drop-off day events at regional 36 locations; (D) in-home disposal methods that render a product safe from misuse and that comply 37 with applicable controlled substance regulations and environmental safety regulations; or (E) any 38 other method recommended pursuant to United States Drug Enforcement Administration 39 guidelines; 40 (ii) for sharps, a mail-back collection system that provides prepaid and preaddressed 41 packaging for a pharmacy to distribute when filling a prescription that includes sharps or upon 42 request by a consumer that shall include but not be limited to: (a) the contact information for the 43 operator of the program and for each entity participating in the program; (b) the list of sharps 44 sold or offered by sale by each participating entity covered by the stewardship program; (c) the 45 name and contact information of the service provider to be used to transport, process, or dispose 46 of sharps collected through the stewardship program; (d) safe and secure processes that collect, 47 track, and properly manage sharps waste from collection through final disposal; (e) sufficient 48 amounts of sharps disposal containers to accommodate the volume of sharps purchased by the 49 consumer over a selected time period; (f) all necessary information for the consumer on the 50 proper disposal of sharps; (g) a label affixed to the sharps disposal container or packaging or on a 51 separate sheet with the program operator’s internet website and toll-free telephone number; (h) 52 all necessary prepaid postage and mail-back packaging; 53 (iii) adequate provisions for the security of unwanted drugs throughout the collection 54 process and the safety of any person involved in monitoring, staffing, or servicing the 55 stewardship program; 4 of 4 56 (iv) a plan for the manufacturer or stewardship organization that provides the operational 57 and administrative costs associated with the program; provided, however that no point-of-sale, 58 point-of-collection, processing fees or other drug cost increases may be charged to individual 59 consumers to recoup program costs; 60 (v) an attestation that the program shall comply with all applicable state and federal 61 requirements for the collection, security, transport and disposal of drug products, including any 62 requirements established by the rule or regulation of either the United States Drug Enforcement 63 Administration or the United States Environmental Protection Agency; and 64 (vi) any other requirements established by the department for the sale and effective 65 administration of a drug stewardship program.