U.S. District Court defends pharmacy compounding

Landmark decision puts authority for compounding in hands of state boards of pharmacy, not FDA.

FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy, determined Judge Timothy Corrigan of the U.S. District Court for the Middle District of Florida in the case of U.S. v Franck’s Lab, Inc.

The lawsuit, brought by FDA against Paul Franck, BSPharm, FIACP, President and CEO of Franck’s Lab in Ocala, FL, alleged that Franck’s use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non–food producing animals was illegal. The agency contended that Franck’s Lab and all other pharmacists compounding veterinary preparations with APIs were in violation of the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, the FDA Compliance Policy Guide (CPG), and the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938. FDA argued that the veterinary preparations should be considered new drugs and are thus subject to FDA review and approval.

Corrigan determined that the authority for regulating the compounding of medications by licensed pharmacies rests with state boards of pharmacy, not FDA, as long as a pharmacy’s activities are not manufacturing. Corrigan added that AMDUCA did not give FDA the authority to prohibit the use of bulk APIs in veterinary compounding, that FDA’s 2003 CPG on veterinary compounding cannot be used as the basis for regulatory action, and that FDCA did not give FDA jurisdiction over pharmacy compounding.

In his decision, Corrigan wrote that while he “appreciates FDA’s difficult task in protecting the health of both humans and animals … FDA’s authority is not unlimited and courts have a role to play in determining whether the agency’s actions exceed the statutory powers given to it by Congress.”

“This ruling is a significant victory for compounding pharmacists and the veterinary patients and practitioners they serve,” said John Herr, BSPharm, FIACP, President of the International Academy of Compounding Pharmacists, in a news release. “Not only does it clearly refute FDA’s attempts to exert unauthorized jurisdiction over compounding, it is sharply critical of FDA’s approach towards veterinary compounding in particular.”

Corrigan’s ruling also noted that a the size and scope of a pharmacy’s compounding do not necessarily mean that it is a manufacturer and that it was contradictory to prohibit the use of bulk APIs in veterinary compounding while permitting their use in compounding for humans.