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Are You a Virtual Manufacturer?

Many of Safety Partners’ clients hold Controlled Substances Registrations (Researcher) for the research use of controlled substances.  In Massachusetts, a controlled substance includes all drugs regulated by the Drug Enforcement Agency (DEA) in schedules I through V as well as Schedule VI, which is defined as all prescription drugs, which are not included in any other schedule.  In addition to Researcher Registrations, the Massachusetts Department of Public health (DPH) has required registrations for controlled substances Manufacturers.

Did you know that the Mass DPH now requires registrations for Virtual Manufacturers?  A Virtual Manufacturer is defined as “a person in the business of manufacturing or distributing a controlled substance and who has a principal place of business located in the Commonwealth, but at no time takes physical possession of any controlled substance in the Commonwealth.”  Under this definition, you would be a virtual manufacturer if your company was using a contract manufacturing organization (CMO) for drug manufacturing.

This change is described in the November 2018 update to 105 CMR 700.000 (Regulations Implementing the Provisions of M.G.L. c. 94C, The Controlled Substances Act).  There is now a specific application for Virtual Manufacturers which can be found on the DPH website. http://www.mass.gov/dph/dcp

Massachusetts is not currently conducting inspections at virtual manufacturers; however, they reserve the right to inspect at any time. Based on information on virtual manufacturer inspections in other states, if an inspection were to occur it may include a review of:

  • Name and address of your contract manufacturer(s)
  • Whether or not there is any drug product on site to confirm that your company is truly a virtual manufacturer
  • Drug distribution policies, procedures, and responsible parties
  • Policies and procedures for returned product accidently being sent to you directly, and not the manufacturer.

 

If you are a virtual manufacturer and have any questions on the new requirements or navigating the Massachusetts Controlled Substances Regulations, please email info@safetypartnersinc.com.

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