This policy is intended to assist manufacturers and/or distributors of medical devices in Massachusetts to ascertain whether they need to obtain a controlled substances registration from the Massachusetts Department of Public Health (MDPH). Such a controlled substances registration would be required under Massachusetts law and regulation (M.G.L. c. 94C and 105 CMR 700.000) if a company were to manufacture, distribute or dispense controlled substances in the Commonwealth, or possess controlled substances with the intent of manufacturing, distributing or dispensing. Please note that in accordance with Massachusetts law the term "controlled substance" denotes any prescription pharmaceutical (i.e., either a federally controlled substance or a "legend" drug). Thus, any medical device that contains a prescription pharmaceutical is considered to be a controlled substance in Massachusetts regardless of its standing as a medical device.
If you are a manufacturer and/or a distributor in Massachusetts and your company does not manufacture, dispense or distribute controlled substances within the Commonwealth, or possess controlled substances for such purposes your company does not need, and has no basis for obtaining, a controlled substances registration from Massachusetts.
Thus, for example, a manufacturer or distributor of a medical device is not required to register if:
- the device does not contain any prescription pharmaceutical;
- the device does contain a prescription pharmaceutical but is not manufactured, stored, dispensed, or distributed from within the Commonwealth (e.g., manufacture, storage and distribution of the device is handled from outside the state and the only activity within Massachusetts is direct delivery to a registered entity in the state).
If you have any questions regarding this policy please contact the Drug Control Program at 617-983-6700.