§ 291 — Drug take back

New York § 291

• Jurisdiction: New York
• Law PBH: Public Health
• Art. 2-B: Drug Take Back

Text

§ 291. Drug take back. 1. Any manufacturer of a covered drug shall:\n (a) operate a drug take back program approved by the department\nindividually or jointly with other manufacturers;\n (b) enter into an agreement with a drug take back organization which\nshall operate a drug take back program approved by the department; or\n (c) enter into an agreement with the department to operate a drug take\nback program on its behalf.\n 2. Any manufacturer of a covered drug, individually or jointly, or a\ndrug take back organization contracted by a manufacturer of a covered\ndrug shall within one hundred eighty days from the effective date of\nthis section submit to the department, in a manner and form determined\nby the department, a proposed drug take back program that meets, at a\nminimum, the following requirements:\n (a) Certifies the drug take back program will accept all covered drugs\nregardless of who produced them;\n (b) Provides contact information for the person submitting the planned\ndrug take back program with whom the department shall direct all\ninquiries;\n (c) Details a collection system to provide convenient, ongoing\ncollection services to all persons seeking to dispose of covered drugs\npursuant to section two hundred ninety-two of this article that is\ngeographically distributed in a way to ensure access in rural and\nunderserved areas;\n (d) Describes other collection methods by which covered drugs will be\ncollected by authorized collectors;\n (e) Explains how covered drugs will be safely and securely tracked and\nhandled from collection through final disposal and destruction, policies\nto ensure security and compliance with all applicable laws and\nregulations including disposal and destruction at a permitted waste\ndisposal facility meeting federal requirements;\n (f) Describes the public education and outreach activities that will\nbe undertaken which shall include advertising of collection locations on\na website and through use of signage and other written materials, and\nhow effectiveness will be evaluated;\n (g) Details how the costs of pharmacy collection and other authorized\ncollectors will be reimbursed which shall include costs retroactive to\nthe effective date of this article, and where more than one manufacturer\nwill be involved in the planned drug take back program, a plan for the\nfair and reasonable manner of allocated costs among the participants in\nsuch program such that the costs paid by each manufacturer is reasonably\nrelated to the volume or value of covered drugs sold in the state; and\n (h) Provides any further information deemed appropriate by the\ndepartment.\n 3. Within thirty days of the effective date of this section, each\nwholesaler that sells covered drugs in or into the state shall provide\nthe department with a list of manufacturers that produce covered drugs.\nThe department may request updated lists at its discretion.\n 4. A manufacturer, individually or jointly, must pay all\nadministrative and operational fees associated with the drug take back\nprogram, including the cost of collecting, transporting and disposing of\ncovered drugs from pharmacies and other authorized collectors and the\nrecycling or disposal, or both, of packing collected with the covered\ndrug. Manufacturers shall also pay costs incurred by the state in the\nadministration and enforcement of the drug take back program. Exclusive\nof fines and penalties, the state shall only recover its actual cost of\nadministration and enforcement. In instances where manufacturers jointly\nconduct a drug take back program, the costs of administration and\nenforcement shall be fairly and reasonably allocated such that the\nportion of costs is reasonably related to the volume or value of covered\ndrugs the manufacturers sell in the state. No manufacturer may charge a\npoint-of-sale or other fee to consumers, or a fee that could be passed\non to consumers, to recoup the cost of their drug take back program.\n 5. Within sixty days of receipt of a proposed drug take back program,\nthe department, in consultation with the department of environmental\nconservation, shall determine whether such proposed drug take back\nprogram complies with the requirements of this article and notify the\napplicant. The department may conduct a noticed public hearing prior to\napproval. If the drug take back program is approved, the department\nshall notify the applicant in writing. If the drug take back program is\nnot approved, the department shall notify the applicant in writing and\nthe applicant shall submit a revised drug take back program proposal\nwithin thirty days. If the department rejects the subsequent proposal,\nthe manufacturer or manufacturers at issue shall be out of compliance\nwith this article and subject to the enforcement provisions pursuant to\nsection two hundred ninety-four of this article. The department shall\nprovide, and update annually, on its website a list of all manufacturers\nparticipating in a drug take back program approved by the department.\n 6. At least every three years, a manufacturer, jointly or\nindividually, or a drug take back organization shall update its drug\ntake back program and submit an updated proposal to the department. A\nmanufacturer who begins to offer a covered drug in the state after the\neffective date of this article, shall provide evidence of joining an\nexisting approved drug take back program or submit a proposal for a drug\ntake back program within ninety days following the initial offer for\nsale of a covered drug. Any proposed change to a drug take back program\nshall be submitted in writing and approved by the department prior to\nany change.\n 7. Each approved drug take back program shall report to the department\nat a date and manner set by the department. The department shall submit\nan annual report to the governor, speaker of the assembly and temporary\npresident of the senate by January first detailing all program\nactivities, the weight collected by each program, a description of\ncollection activities, the name and location of all collection sites,\npublic education and outreach activities, an evaluation of the efficacy\nof the program and each collection method, and any manufacturer out of\ncompliance or subject to penalties pursuant to section two hundred\nninety-four of this article.\n