Compounding pharmacies not under FDA jurisdictional authority, federal judge rules

HOUSTON — A recent federal court ruling could have big implications for compounding pharmacies.



The case of US v. Franck's Lab, Inc., in the U.S. District Court for the Middle District of Florida, concerned pharmacies that compound medications for animals. The Food and Drug Administration brought the case against Ocala, Fla., pharmacist Paul Franck, saying that the use of active pharmaceutical ingredients in compounding veterinary drugs for nonfood producing animals was illegal. But judge Timothy Corrigan disagreed, ruling that the Food and Drug Administration did not have jurisdictional authority over the compounding of medications by a licensed pharmacy as long as the pharmacy's activities were not manufacturing. Rather, Corrigan ruled, that authority rests with individual state Boards of Pharmacy because Congress did not grant it to the FDA when it enacted the Food Drug and Cosmetic Act of 1938.



"Not only does it clearly refute the FDA's attempts to exert unauthorized jurisdiction over compounding; it is sharply critical of the FDA's approach towards veterinary compounding in particular," International Academy of Compounding Pharmacists president John Herr said. "Judge Corrigan correctly ruled that Congress never intended the FDA to prohibit the use of APIs in veterinary compounding. He also clearly stated what IACP has said for years: The FDA does not have jurisdiction over the traditional practice of pharmacy compounding."