Who needs to file?
You must file a plan with the Department if both of the following applies to you:
- You are an entity that manufactures one or more controlled substances under a U.S. Food and Drug Administration manufacturer's license
- This excludes institutional pharmacies, as defined in M.G.L. c. 112, § 39D, and wholesalers licensed pursuant to M.G.L. c. 112, § 36B
- You sell or distribute any “covered drug” to consumers in the Commonwealth, whether directly or through a wholesaler, retailer, or other agent
Additional Resources
Approved Drug Stewardship Plans
"Covered drugs" - definition and exceptions
A “covered drug” is any brand name or generic Schedule II or Schedule III opioid drug, and benzodiazepines.
The following items are specifically excluded from the definition of “covered drug”:
- Drugs intended for use solely in veterinary care
- Cosmetic products as defined in 21 U.S.C. § 301 et seq., the U.S. Food, Drug & Cosmetic Act
- Drugs compounded under a specialty license pursuant to M.G.L. c. 112, §§ 39G through 39J
- Hypodermic needles, lancets, or other sharps products subject to collection and disposal procedures established under M.G.L. c. 94C, § 27A through 39J
- Drugs approved and used primarily for medication-assisted substance use disorder treatment
Additional Resources
If a manufacturer sells products to a wholesaler
Some pharmaceutical drug manufacturers sell their products to a wholesaler. This means the wholesaler now owns the products and decides to sell the product in any state of their choice.
If the wholesaler distributes the product to the Commonwealth of Massachusetts, the manufacturer still needs to file a plan to operate a Drug Stewardship Program. It doesn’t matter whether the manufacturer sells or distributes directly to Massachusetts consumers, or whether its products travel to Massachusetts consumers indirectly through a wholesaler or other intermediary. The law states that if a manufacturer’s covered products are sold or distributed to consumers in Massachusetts, the manufacturer must file a plan to operate a Drug Stewardship Program.
If the manufacturer’s covered products don't make it to the Massachusetts market in any way, you don't need to file a stewardship plan.
Virtual manufacturers
Virtual manufacturers do not physically manufacture any product. Instead, they contract with contract manufacturing organizations to produce products. Only the virtual manufacturer must follow the Drug Stewardship Program, and not the contract manufacturer. The virtual manufacturer is ultimately responsible for the drug products.
Determining if the Drug Stewardship program applies to you
Each manufacturer is responsible for determining if the Drug Stewardship Program applies to them or not. The Department will not confirm whether it applies to you or not.
A manufacturer that believes it's not required to file a Drug Stewardship Program plan may fill out the Drug Stewardship Non-Participation Form and file it with the Department, which will consider the request.
You can submit a non-participation form if any of the following applies to you:
- You don't manufacture controlled substances under a U.S. Food and Drug Administration manufacturer's license
- You don't sell or distribute to consumers in the Commonwealth of Massachusetts, whether directly or through a wholesaler, retailer, or other agent
- You don't sell or distribute brand name or generic Schedule II or Schedule III opioid drugs, or benzodiazepines
- The only drugs which you sell or distribute, whether directly or through a wholesaler, retailer, or other agent, are any of the following:
- Drugs intended for use solely in veterinary care
- Cosmetic products as defined in 21 U.S.C. § 301 et seq., the U.S. Food, Drug & Cosmetic Act
- Drugs compounded under a specialty license pursuant to M.G.L. c. 112, §§ 39G through 39J
- Hypodermic needles, lancets or other sharps products subject to collection and disposal procedures established in accordance with M.G.L. c. 94C, § 27A through 39J
- Drugs approved and used primarily for medication-assisted substance use disorder treatment
- The only drugs which you sell or distribute to consumers in the Commonwealth of Massachusetts, whether directly or through a wholesaler, retailer, or other agent, are any of the following:
- Drugs intended for use solely in veterinary care
- Cosmetic products as defined in 21 U.S.C. § 301 et seq., the U.S. Food, Drug & Cosmetic Act
- Drugs compounded under a specialty license pursuant to M.G.L. c. 112, §§ 39G through 39J
- Hypodermic needles, lancets or other sharps products subject to collection and disposal procedures established in accordance with M.G.L. c. 94C, § 27A through 39J
- Drugs approved and used primarily for medication-assisted substance use disorder treatment.
We will add a link here to the page "File a non-participation form for the Drug Stewardship Program"
Additional Resources
Are there templates for making a plan?
We don't have a template now for drug manufacturers to use to create their own Drug Stewardship Programs.
Please refer to the statute (M.G.L. c. 94H) and Department guidance, which outline the process and requirements.
If you are a small manufacturer of covered drugs that are sold or distributed in the commonwealth, you can meet the plan requirement in several ways:
- You can create your own individual plan
- You can find one or more other manufacturers and join them to create a joint plan
- You can request to be connected with a group that has already filed a plan. Whether it will be permitted to join, and the conditions of joining, are up to the filing group.
Additional Resources
Are there any alternatives to filing a Drug Stewardship Program Plan?
Pursuant to M.G.L. c. 94H, § 6, the Department will develop an alternative plan for compliance beginning January 1, 2018. For the first year, the Department will not make an alternative plan available as an option, and manufacturers of covered drugs must file their own individual or group plan.
Additional Resources
Laws and regulations
The regulations, with respect to enforcement and appeals, will be drafted and open to public comment in the future.