FDA Appeals Finding that it Lacks Power to Prohibit State-Licensed Veterinary Compounding

Nov 23, 2011   
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On November 11, 2011, the U.S. Food and Drug Administration (FDA) appealed a recent decision issued by the District Court for the Middle District of Florida, finding that the FDA lacked the authority to prohibit state-licensed veterinary compounding. The September 12, 2011 decision being appealed details the longstanding practice of pharmacy compounding in the context of veterinary medicine.

Compounding is commonly defined by state law as the practice of filling prescriptions through individualized preparation, as opposed to the manufacturing of drugs in bulk. Unlike the compounding of human drugs, over which the FDA acknowledges it lacks full regulatory control if the compounding pharmacy meets certain requirements, the FDA maintains that it possesses the authority to regulate veterinary compounding.

The case originated after the accidental death of 21 polo horses that received compounded drugs from Franck’s Lab, Inc. (Franck’s), an incident that was ultimately linked to a mathematical error in the issuing veterinarian’s prescription. In addition, Franck’s had received FDA Warning Letters in 2004 and 2005, alleging that Franck’s was impermissibly manufacturing drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA). In response to the Warning Letters, Franck’s argued that “[s]tate law and good compounding practices . . . allow bulk compounding as long as there is a valid patient physician (veterinarian) relationship.” Because the FDA permits compounding of drugs for human use, Franck’s argued that the FDA must allow the same for veterinary compounding. The FDA, however, rejected this argument and brought suit against Franck’s in April 2010 seeking injunctive relief to stop Franck’s from compounding and distributing animal drugs.

In its order, the District Court found for Franck’s and held that because the states have traditionally exercised authority over pharmacy compounding, the states likewise have the authority to regulate the compounding of animal drugs. By filing its notice of appeal, the FDA has signaled that it is not willing to concede the issue of its authority to regulate veterinary compounding.

Fuerst Ittleman will continue to monitor the Franck’s case. For more information, please contact us at contact@fidjlaw.com.