Massachusetts Enacts First-in-Country Opioid Take Back Law
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On March 14, 2016, Governor Charlie Baker of Massachusetts signed a bill entitled “An Act Relative to Substance Use, Treatment, Education and Prevention.” This legislation contains multiple provisions designed to control opioid abuse and addiction. It also includes the nation’s first statewide opioid take back program, under which manufacturers of opioid drugs must establish, implement, and pay for an opioid product stewardship program in Massachusetts.
Below are the essential features of the new Massachusetts Drug Stewardship Program.
Is the Massachusetts Drug Stewardship Program limited to opioids? Yes. The drug stewardship program is only required to address unwanted (abandoned, discarded, expired, surrendered) opioid drugs from residents. The phrase “opioid drugs” refers to opioid drugs in Schedule II or III of the Massachusetts Controlled Substances Act and to benzodiazepines with certain exceptions.
What is required? The Massachusetts Drug Stewardship Program requires manufacturers of brand name and generic opioids to participate in an opioid stewardship program approved by the Massachusetts Department of Public Health (“Department”) for the collection, transport and disposal of unwanted opioid drugs from residents, or enter into an alternative plan developed by the Department in consultation with stakeholders.
What is the Massachusetts Drug Stewardship Program? It is a program to collect, secure, transport, and safely dispose of unwanted household opioid drugs.
How will opioid drugs from residents be collected and disposed? The statute requires that any drug stewardship program include two of the following collection and disposal methods: (a) a mail–back program; (b) collection kiosks; (c) drop-off-days at regional locations; (d) in-home disposal methods that render the product safe and comply with controlled substance and environmental regulations; and (e) any other method recommended by U.S. Drug Enforcement Administration guidelines.
Who will finance the programs? The manufacturers of opioid drugs are required to pay for all costs of the unwanted household opioid drug collection and disposal programs, at no cost to consumers or governmental entities.
When will drug stewardship programs be in place? Likely 2018. The section of the statute covering the Massachusetts Drug Stewardship Program does not become effective until January 1, 2017. We expect that the development of regulations will begin in 2016.
Beveridge & Diamond regularly helps clients understand and comply with local, state and regulatory requirements for discarded pharmaceuticals and other consumer products, including waste management requirements under hazardous waste and medical/infectious waste programs, transport requirements under the federal Hazardous Materials Transportation Act, and Drug Enforcement Administration requirements applicable to the takeback of controlled substances. For more information on the Massachusetts Drug Stewardship Program, please contact Jeanine Grachuk ([email protected], 781.416.5713) or Don Patterson ([email protected], 202.789.6032).