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2 | 2 | | HOUSE DOCKET, NO. 3144 FILED ON: 1/16/2025 |
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3 | 3 | | HOUSE . . . . . . . . . . . . . . . No. 2417 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Carole A. Fiola |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act relative to medical sharps stewardship. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :DATE ADDED:Carole A. Fiola6th Bristol1/16/2025 1 of 4 |
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16 | 16 | | HOUSE DOCKET, NO. 3144 FILED ON: 1/16/2025 |
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17 | 17 | | HOUSE . . . . . . . . . . . . . . . No. 2417 |
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18 | 18 | | By Representative Fiola of Fall River, a petition (accompanied by bill, House, No. 2417) of |
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19 | 19 | | Carole A. Fiola relative to medical sharps stewardship. Public Health. |
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20 | 20 | | The Commonwealth of Massachusetts |
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21 | 21 | | _______________ |
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22 | 22 | | In the One Hundred and Ninety-Fourth General Court |
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23 | 23 | | (2025-2026) |
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24 | 24 | | _______________ |
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25 | 25 | | An Act relative to medical sharps stewardship. |
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26 | 26 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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27 | 27 | | of the same, as follows: |
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28 | 28 | | 1 SECTION 1. Section 1 of chapter 94H of the General Laws, as appearing in the 2022 |
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29 | 29 | | 2Official Edition, is hereby amended by striking out the second paragraph and inserting in place |
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30 | 30 | | 3thereof the following paragraph:- |
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31 | 31 | | 4 “Covered drug”, any brand name or generic opioid drug placed in Schedule II or |
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32 | 32 | | 5Schedule III of section 3 of chapter 94C; provided, however, that “covered drug” shall also |
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33 | 33 | | 6include “(i) benzodiazepines, and (ii) sharps subject to collection and disposal procedures |
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34 | 34 | | 7established in section 27A of chapter 94C; provided, further, that “covered drug” shall not |
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35 | 35 | | 8include (i) drugs intended for use solely in veterinary care; (ii) substances that are regulated as |
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36 | 36 | | 9cosmetic products under the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq; |
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37 | 37 | | 10(iii) drugs that are compound under a specialty license pursuant to sections 39G to 39J, inclusive, |
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38 | 38 | | 11of chapter 112; or (iv) drugs approved and used primarily for medication-assisted substance use |
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39 | 39 | | 12disorder treatment. 2 of 4 |
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40 | 40 | | 13 SECTION 2. Said section 1 of chapter 94H, is hereby further amended by inserting the |
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41 | 41 | | 14following definition:- |
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42 | 42 | | 15 “Sharps”, objects with sharp points or edges that can puncture or cut skin, which shall |
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43 | 43 | | 16include but are not limited to hypodermic needles, syringes, lancets, auto injectors, infusion sets, |
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44 | 44 | | 17and connection needles. |
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45 | 45 | | 18 SECTION 3. Said section 1 of chapter 94H, is hereby further amended by inserting the |
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46 | 46 | | 19following definition:- |
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47 | 47 | | 20 “Sharps disposal containers”, containers made from rigid puncture-resistant plastic or |
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48 | 48 | | 21metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an |
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49 | 49 | | 22opening to accommodate depositing a sharp but not large enough for a hand to enter. |
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50 | 50 | | 23 SECTION 4. Section 3 of chapter 94H, as so appearing, is hereby amended by striking |
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51 | 51 | | 24out the section in its entirety and inserting in place thereof the following section:- |
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52 | 52 | | 25 Section 3. A manufacturer or stewardship organization seeking approval for a drug |
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53 | 53 | | 26stewardship program shall submit, in a manner and form determined by the department, a plan |
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54 | 54 | | 27that meets, but is not limited to, the following requirements: |
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55 | 55 | | 28 (i) for all covered drugs not including sharps, a collection system to provide convenient, |
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56 | 56 | | 29ongoing collection services to all persons seeking to dispose of unwanted drugs; provided, |
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57 | 57 | | 30however, that the collection system may accept any covered drug and any other prescription drug |
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58 | 58 | | 31in a pill formulation regardless of its schedule, brand or source of manufacture; provided further, |
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59 | 59 | | 32that the collection system shall include 2 methods as recommended by the department, which |
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60 | 60 | | 33may include, but not be limited to: (A) a mail-back program that provides prepaid and 3 of 4 |
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61 | 61 | | 34preaddressed packaging for a pharmacy to distribute when filling a prescription for a covered |
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62 | 62 | | 35drug or upon request by a consumer; (B) collection kiosks; (C) drop-off day events at regional |
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63 | 63 | | 36locations; (D) in-home disposal methods that render a product safe from misuse and that comply |
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64 | 64 | | 37with applicable controlled substance regulations and environmental safety regulations; or (E) any |
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65 | 65 | | 38other method recommended pursuant to United States Drug Enforcement Administration |
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66 | 66 | | 39guidelines; |
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67 | 67 | | 40 (ii) for sharps, a mail-back collection system that provides prepaid and preaddressed |
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68 | 68 | | 41packaging for a pharmacy to distribute when filling a prescription that includes sharps or upon |
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69 | 69 | | 42request by a consumer that shall include but not be limited to: (a) the contact information for the |
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70 | 70 | | 43operator of the program and for each entity participating in the program; (b) the list of sharps |
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71 | 71 | | 44sold or offered by sale by each participating entity covered by the stewardship program; (c) the |
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72 | 72 | | 45name and contact information of the service provider to be used to transport, process, or dispose |
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73 | 73 | | 46of sharps collected through the stewardship program; (d) safe and secure processes that collect, |
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74 | 74 | | 47track, and properly manage sharps waste from collection through final disposal; (e) sufficient |
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75 | 75 | | 48amounts of sharps disposal containers to accommodate the volume of sharps purchased by the |
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76 | 76 | | 49consumer over a selected time period; (f) all necessary information for the consumer on the |
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77 | 77 | | 50proper disposal of sharps; (g) a label affixed to the sharps disposal container or packaging or on a |
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78 | 78 | | 51separate sheet with the program operator’s internet website and toll-free telephone number; (h) |
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79 | 79 | | 52all necessary prepaid postage and mail-back packaging; |
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80 | 80 | | 53 (iii) adequate provisions for the security of unwanted drugs throughout the collection |
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81 | 81 | | 54process and the safety of any person involved in monitoring, staffing, or servicing the |
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82 | 82 | | 55stewardship program; 4 of 4 |
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83 | 83 | | 56 (iv) a plan for the manufacturer or stewardship organization that provides the operational |
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84 | 84 | | 57and administrative costs associated with the program; provided, however that no point-of-sale, |
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85 | 85 | | 58point-of-collection, processing fees or other drug cost increases may be charged to individual |
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86 | 86 | | 59consumers to recoup program costs; |
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87 | 87 | | 60 (v) an attestation that the program shall comply with all applicable state and federal |
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88 | 88 | | 61requirements for the collection, security, transport and disposal of drug products, including any |
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89 | 89 | | 62requirements established by the rule or regulation of either the United States Drug Enforcement |
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90 | 90 | | 63Administration or the United States Environmental Protection Agency; and |
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91 | 91 | | 64 (vi) any other requirements established by the department for the sale and effective |
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92 | 92 | | 65administration of a drug stewardship program. |
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