DIVISION OF DRUGS, DEVICES AND COSMETICS
Are there any exceptions to the licensing requirements under Chapter 499, Florida Statutes?
Here are two exceptions:
- Intracompany Transfers to Florida-Located Prescription Drug Wholesale Distributor Permittees. An out-of-state prescription drug wholesale distributor permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesale distributor, in its state of residence, to a licensed prescription drug wholesale distributor in this state, if both wholesale distributors conduct wholesale distributions of prescription drugs under the same business name.
- API Distributions for Research & Development to Florida Prescription Drug Manufacturers. An unlicensed nonresident manufacturer may distribute (i) a prescription drug active pharmaceutical ingredient (not a finished dosage form), (ii) that it manufactures, (iii) to a prescription drug manufacturer permitted in this state, and (iv) in limited quantities intended for research and development and not for resale, or human use other than lawful clinical trials and biostudies authorized and regulated by federal law.