DIVISION OF DRUGS, DEVICES AND COSMETICS
My company manufactures and/or distributes active pharmaceutical ingredient (“API”) to customers in Florida. Do we need a permit?
Possibly. API’s are “drugs” under Chapter 499, Florida Statutes. DDC regulatory authority over drugs, (medical) devices and cosmetics falls into two main categories:
(a) manufacturing and repackaging of drugs, medical devices and cosmetics conducted in Florida, and
(b) distributing drugs, medical devices and cosmetics in and into Florida.
For further information see FAQ #1.