SECTION 3. Drug stewardship program plan; requirements

[Text of section effective until December 31, 2021. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77.]

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.