DIVISION OF DRUGS, DEVICES AND COSMETICS
My company distributes medical convenience kits and other “combination products” to customers in Florida. Do we need a permit?
Possibly. Florida law contains no exemption for “combination products” containing prescription drugs. As such, medical convenience kits that contain prescription drugs are generally regulated as prescription drugs. For a definition of Combination Products check out:
http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm
Unless you are the “manufacturer” of all the prescription drugs contained in the combination product, a (Nonresident) Prescription Drug Manufacturer permit may not provide appropriate licensure under Chapter 499, Florida Statutes.