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HOUSE DOCKET, NO. 3144 FILED ON: 1/16/2025
HOUSE . . . . . . . . . . . . . . . No. 2417
The Commonwealth of Massachusetts
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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.
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PETITION OF:
NAME:DISTRICT/ADDRESS :DATE ADDED:Carole A. Fiola6th Bristol1/16/2025 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
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In the One Hundred and Ninety-Fourth General Court
(2025-2026)
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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
2Official Edition, is hereby amended by striking out the second paragraph and inserting in place
3thereof the following paragraph:-
4 “Covered drug”, any brand name or generic opioid drug placed in Schedule II or
5Schedule III of section 3 of chapter 94C; provided, however, that “covered drug” shall also
6include “(i) benzodiazepines, and (ii) sharps subject to collection and disposal procedures
7established in section 27A of chapter 94C; provided, further, that “covered drug” shall not
8include (i) drugs intended for use solely in veterinary care; (ii) substances that are regulated as
9cosmetic 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,
11of chapter 112; or (iv) drugs approved and used primarily for medication-assisted substance use
12disorder treatment. 2 of 4
13 SECTION 2. Said section 1 of chapter 94H, is hereby further amended by inserting the
14following definition:-
15 “Sharps”, objects with sharp points or edges that can puncture or cut skin, which shall
16include but are not limited to hypodermic needles, syringes, lancets, auto injectors, infusion sets,
17and connection needles.
18 SECTION 3. Said section 1 of chapter 94H, is hereby further amended by inserting the
19following definition:-
20 “Sharps disposal containers”, containers made from rigid puncture-resistant plastic or
21metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an
22opening 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
24out 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
26stewardship program shall submit, in a manner and form determined by the department, a plan
27that meets, but is not limited to, the following requirements:
28 (i) for all covered drugs not including sharps, a collection system to provide convenient,
29ongoing collection services to all persons seeking to dispose of unwanted drugs; provided,
30however, that the collection system may accept any covered drug and any other prescription drug
31in a pill formulation regardless of its schedule, brand or source of manufacture; provided further,
32that the collection system shall include 2 methods as recommended by the department, which
33may include, but not be limited to: (A) a mail-back program that provides prepaid and 3 of 4
34preaddressed packaging for a pharmacy to distribute when filling a prescription for a covered
35drug or upon request by a consumer; (B) collection kiosks; (C) drop-off day events at regional
36locations; (D) in-home disposal methods that render a product safe from misuse and that comply
37with applicable controlled substance regulations and environmental safety regulations; or (E) any
38other method recommended pursuant to United States Drug Enforcement Administration
39guidelines;
40 (ii) for sharps, a mail-back collection system that provides prepaid and preaddressed
41packaging for a pharmacy to distribute when filling a prescription that includes sharps or upon
42request by a consumer that shall include but not be limited to: (a) the contact information for the
43operator of the program and for each entity participating in the program; (b) the list of sharps
44sold or offered by sale by each participating entity covered by the stewardship program; (c) the
45name and contact information of the service provider to be used to transport, process, or dispose
46of sharps collected through the stewardship program; (d) safe and secure processes that collect,
47track, and properly manage sharps waste from collection through final disposal; (e) sufficient
48amounts of sharps disposal containers to accommodate the volume of sharps purchased by the
49consumer over a selected time period; (f) all necessary information for the consumer on the
50proper disposal of sharps; (g) a label affixed to the sharps disposal container or packaging or on a
51separate sheet with the program operator’s internet website and toll-free telephone number; (h)
52all necessary prepaid postage and mail-back packaging;
53 (iii) adequate provisions for the security of unwanted drugs throughout the collection
54process and the safety of any person involved in monitoring, staffing, or servicing the
55stewardship program; 4 of 4
56 (iv) a plan for the manufacturer or stewardship organization that provides the operational
57and administrative costs associated with the program; provided, however that no point-of-sale,
58point-of-collection, processing fees or other drug cost increases may be charged to individual
59consumers to recoup program costs;
60 (v) an attestation that the program shall comply with all applicable state and federal
61requirements for the collection, security, transport and disposal of drug products, including any
62requirements established by the rule or regulation of either the United States Drug Enforcement
63Administration or the United States Environmental Protection Agency; and
64 (vi) any other requirements established by the department for the sale and effective
65administration of a drug stewardship program.