DRUG STEWARDSHIP PROGRAM

M.G.L. pt. Part I, tit. Title XV, ch. c. 94H

in effect

M.G.L. c. 94H, § 1 Definitions

c. 94H, § 1. Definitions [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 1. As used in this chapter, the following words shall have the following meanings unless the context clearly requires otherwise: ''Covered drug'', any brand name or generic opioid drug placed in Schedule II or Schedule III of section 3 of chapter 94C; provided, however, that ''covered drug'' shall also include benzodiazepines; provided, further, that ''covered drug'' shall not include: (i) drugs intended for use solely in veterinary care; (ii) substances that are regulated as cosmetic products under the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.; (iii) drugs that are compounded under a specialty license pursuant to sections 39G to 39J, inclusive, of chapter 112; (iv) hypodermic needles, lancets or other sharps products subject to collection and disposal procedures established in section 27A of chapter 94C; or (v) drugs approved and used primarily for medication-assisted substance use disorder treatment. ''Department'', the department of public health. ''Drug stewardship program'', a program financed by a pharmaceutical product manufacturer or a group of manufacturers to collect, secure, transport and safely dispose of unwanted drugs. ''Pharmaceutical product manufacturer'' or ''manufacturer'', an entity that manufactures a controlled substance under a United States Food and Drug Administration manufacturer's license, except for an institutional pharmacy, as defined in section 39D of chapter 112 or a wholesaler. ''Prescription drug'', any drug product which may be dispensed pursuant to chapter 94C under a written prescription by an authorized prescriber. ''Stewardship organization'', an organization designated by a manufacturer or a group of manufacturers to act as an agent on behalf of the manufacturer or the group of manufacturers to implement and operate a drug stewardship program. ''Unwanted drug'', a covered drug: (i) that is no longer wanted or intended to be consumed, or that is abandoned, discarded, expired or surrendered by the person to whom it was prescribed; or (ii) voluntarily deposited at collection points co-located with a law enforcement agency; provided, however, that ''unwanted drug'' shall not include: (A) waste or unused drug products from a pharmacy, hospital or health clinic or other commercial sources that the department may determine by regulation to be a nonresidential source; or (B) drug products seized by law enforcement officers in the course of their law enforcement duties. ''Wholesaler'', an entity licensed pursuant to section 36B of chapter 112.

M.G.L. c. 94H, § 2 Operation or participation in drug stewardship program required; powers and duties of department

c. 94H, § 2. Operation or participation in drug stewardship program required; powers and duties of department [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 2. (a) Any pharmaceutical product manufacturer selling or distributing a covered drug to consumers in the commonwealth, whether directly or through a wholesaler, retailer or other agent, shall: (i) operate a drug stewardship program approved by the department individually or jointly with other manufacturers; (ii) enter into an agreement with a stewardship organization that shall operate a drug stewardship program approved by the department; or (iii) enter into an agreement with the department to operate an alternative plan under section 6. (b) The department shall establish a process to review applications for approval and renewal of a manufacturer's drug stewardship plan. The department shall consult with the Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other interested parties in developing the requirements of a drug stewardship program. (c) Each operator of a drug stewardship program shall file an annual written report to the department describing the program's activities for the prior year and the volume and type of unwanted drugs collected not later than March 1. (d) The department shall review for renewal each drug stewardship program at a frequency to be determined by the department. (e) The department shall publish and make publicly available a list and description of each approved drug stewardship program and shall update this list at a frequency determined by the department. (f) The department may promulgate regulations to implement this chapter.

M.G.L. c. 94H, § 3 Drug stewardship program plan; requirements

c. 94H, § 3. Drug stewardship program plan; requirements [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 3. A manufacturer or stewardship organization seeking approval for a drug stewardship program shall submit, in a manner and form determined by the department, a plan that meets, but is not limited to, the following requirements: (i) a collection system to provide convenient, ongoing collection services to all persons seeking to dispose of unwanted drugs; provided, however, that the collection system may accept any covered drug and any other prescription drug in a pill formulation regardless of its schedule, brand or source of manufacture; provided further, that the collection system shall include 2 methods as recommended by the department, which may include, but not be limited to: (A) a mail-back program that provides prepaid and preaddressed packaging for a pharmacy to distribute when filling a prescription for a covered drug or upon request by a consumer; (B) collection kiosks; (C) drop-off day events at regional locations; (D) in-home disposal methods that render a product safe from misuse and that comply with applicable controlled substance regulations and environmental safety regulations; or (E) any other method recommended pursuant to United States Drug Enforcement Administration guidelines; (ii) adequate provisions for the security of unwanted drugs throughout the collection process and the safety of any person involved in monitoring, staffing or servicing the stewardship program; (iii) a plan for public outreach and education about the drug stewardship program; (iv) a plan for the manufacturer or stewardship organization that provides the operational and administrative costs associated with the program; provided, however, that no point-of-sale, point-of-collection, processing fees or other drug cost increases may be charged to individual consumers to recoup program costs; (v) an attestation that the program shall comply with all applicable state and federal requirements for the collection, security, transport and disposal of drug products, including any requirements established by rule or regulation of either the United States Drug Enforcement Administration or the United States Environmental Protection Agency; and (vi) any other requirements established by the department for the safe and effective administration of a drug stewardship program.

M.G.L. c. 94H, § 4 Notice of requirements or of noncompliance; penalty; appeal

c. 94H, § 4. Notice of requirements or of noncompliance; penalty; appeal [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 4. (a) The department shall send a notice to a pharmaceutical product manufacturer that sells or distributes a covered drug in the commonwealth that has not submitted an application for approval under section 2, informing the manufacturer of the requirements to comply with this chapter. Any manufacturer in receipt of a notice shall submit an application for approval under said section 2 within 180 calendar days of receipt of such initial notice. (b) Upon becoming aware that a pharmaceutical product manufacturer has discontinued its drug stewardship program or has altered the program such that the program no longer fulfills the requirements of this chapter, the department shall send a notice of noncompliance to the manufacturer. A manufacturer in receipt of a notice of noncompliance shall take all required corrective steps to reestablish compliance with this chapter or submit a written appeal of the notice of noncompliance to the department within 90 days of receipt of the notice of noncompliance. (c) If after consideration of an appeal or if the manufacturer does not appeal within 90 days of receipt of the notice of noncompliance the department determines that the manufacturer continues to be in noncompliance with this chapter, the department may assess the manufacturer a penalty in a manner to be determined by the department. If the department plans to assess a noncompliance penalty against a manufacturer pursuant to this section, the department shall send notice of the penalty and the right to appeal the penalty to the manufacturer.

M.G.L. c. 94H, § 5 Scope of requirements; application to retail or outpatient pharmacies

c. 94H, § 5. Scope of requirements; application to retail or outpatient pharmacies [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 5. (a) The requirements established by the department, in consultation with Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other stakeholders, may exceed, but shall not conflict with, any obligations imposed on a manufacturer by a risk evaluation and mitigation strategy approved by the United States Food and Drug Administration. (b) Nothing in this chapter shall require a retail pharmacy or a pharmacist practicing in a retail setting to participate in the collection, securing, transport or disposal of unwanted drugs. (c) No stewardship program shall require an outpatient pharmacy to participate in the collection, securing, transport or disposal of unwanted drugs or to provide a space for or to maintain a collection kiosk within an outpatient pharmacy unless the pharmacy certifies, in writing, that this participation is voluntary.

M.G.L. c. 94H, § 6 Alternative plan to drug stewardship program

c. 94H, § 6. Alternative plan to drug stewardship program [Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.] Section 6. The department shall, in consultation with the Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other interested parties, develop an alternative plan to the drug stewardship program established under sections 2 to 5, inclusive. A manufacturer who opts into a plan established under this section shall be exempt from sections 2 to 5, inclusive. A plan established under this section may permit contributions by manufacturers to the Substance Abuse Services Fund established in section 2I of chapter 111, in a manner determined by the department. A manufacturer participating in a plan established under this section shall not pass the cost of any contribution on to the consumer or a health insurance carrier.

Source: Massachusetts General Court (malegislature.gov)URL: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXV/Chapter94HFetched: 10/20/2026