The Governor of Massachusetts recently approved legislation that will require pharmaceutical product manufacturers that sell or distribute a covered drug to consumers in Massachusetts, whether through a wholesaler, retailer, or other agent, to:
- Finance and operate a drug stewardship program, either individually or jointly with other manufacturers, approved by the Massachusetts Department of Health ("Department"); or
- Enter into an agreement with a stewardship organization to operate a Department-approved drug stewardship program.
The new law defines a "pharmaceutical product manufacturer" as an "entity that manufactures a controlled substance under a United States Food and Drug Administration manufacturer's license, except for…a wholesaler." The term "covered drug" includes any Schedule II or III brand name or generic opioid drug and benzodiazepines.
This law will require each manufacturer or stewardship organization to submit to the Department for approval a plan implementing its drug stewardship program. In addition to any other requirement established by the Department, the plan must meet the following requirements:
- The collection system must provide convenient, ongoing collection services to all persons seeking to dispose of unwanted drugs. The system may also accept any covered drug and any other prescription drug in a pill form regardless of its schedule, brand or source of manufacture. The collection system must include two, Department-recommended methods including, but not be limited to:
- 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 consumer request;
- Collection kiosks;
- Regional drop-off day events;
- In-home disposal methods; or
- Any other method recommended pursuant to United States Drug Enforcement Administration guidelines.
- The collection system must provide for adequate security of unwanted drugs throughout the collection process and the safety of those involved in monitoring, staffing or servicing the stewardship program.
- There must be a plan for public outreach and education about the drug stewardship program.
- There must be a plan for the manufacturer or stewardship organization that provides the operational and administrative costs associated with the program; no point-of-sale, point-of-collection, processing fees or other drug cost increases may be charged to individual consumers to recoup program costs.
- There must be an attestation that the program complies with all applicable state and federal requirements for the collection, security, transport and disposal of drug products.
Each operator of a drug stewardship program will be required to file with the Department an annual written report describing the program's activities for the prior year, and the volume and type of drugs collected. This law will require the Department to approve each program and review for renewal each program at an established frequency. The Department must also publish and make publicly available a list and description of each approved drug stewardship program and must update the list at a determined frequency.
This law will permit the Department to develop, in consultation with interested parties, an alternative plan to the drug stewardship program. Manufacturers who opt into this plan will not be required to develop a drug stewardship program as discussed above. The alternative plan may permit contributions by manufacturers to Massachusetts' Substance Abuse Services Fund. Manufacturers participating in this alternative plan may not pass the cost of any contribution on to the consumer or a health insurance carrier.
This portion of the law will go into effect on January 1, 2017.
Click here to view the law.