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?
All API’s are “drugs” under Chapter 499, Florida Statutes, and an API is a “prescription drug” if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs. As such, manufacturing or repackaging an API in Florida requires a permit. Distributing an API in or into Florida may require a permit – regardless of where the API is manufactured or by whom.