File a Drug Stewardship Program Plan

Manufacturers of covered drugs must file a plan to operate a Drug Stewardship Program with the Department of Public Health (DPH).

Drug Stewardship Program

The Details of File a Drug Stewardship Program Plan

What you need for File a Drug Stewardship Program Plan

Plans can be filed, financed, and operated either individually or by a group of manufacturers.

A Drug Stewardship Program must be fully financed by the filing drug manufacturer or group of manufacturers.

A Drug Stewardship Program plan must include, but is not limited to:

  • A collection system to provide convenient, ongoing collection services to all persons seeking to dispose of unwanted drugs. 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. The collection system must include at least 2 of the following methods, at least one of which must be methods 1 or 2 below:
    1. A mail-back program that provides prepaid and pre-addressed packaging for a pharmacy to distribute when filling a prescription for a covered drug or upon request by a consumer
    2. Collection kiosks
    3. Drop-off day events at regional locations convenient to the public
    4. In-home disposal methods that render a product safe from misuse and that follow applicable controlled substance regulations and environmental safety regulations.
  • Adequate provisions for the security of unwanted drugs throughout the collection process. There mus also be adequate safety provisions of any person involved in monitoring, staffing, or servicing the stewardship program.
  • A plan for public outreach and education about the Drug Stewardship Program
  • A plan for the manufacturer or stewardship organization that provides the operational and administrative costs associated with the program. However, no point-of-sale, point-of-collection, processing fees, or other drug cost increases may be charged to individual consumers to recoup program costs.
  • An attestation that the program will follow all applicable state and federal requirements for the collection, security, transport, and disposal of drug products. This includes any requirements established by rule or regulation of either the U.S. Drug Enforcement Administration or the U.S. Environmental Protection Agency.
  • A list of all manufacturers participating in the proposed plan and the amount each will contribute to the plan financing. Each manufacturer must also identify all covered drug products sold in the Commonwealth during calendar year 2016, and the number of units of each.

A Drug Stewardship Program doesn't need to provide for disposal of the following drugs:

  • Drugs from a non-residential source, such as waste or unused drug products from a pharmacy, hospital or health clinic, or other commercial sources
  • Drug products seized by law enforcement officers in the course of their law enforcement duties

How to file File a Drug Stewardship Program Plan

Plans must be submitted electronically to drugstewardship@massmail.state.ma.us.

Program-related questions may be sent to the same address.

Downloads for File a Drug Stewardship Program Plan

Contact for File a Drug Stewardship Program Plan

Address
239 Causeway St., Suite 500, Boston, MA 02114
Fax
(617) 753-8083

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