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.