FDA appeals U.S. District Court ruling on pharmacy compounding

November 22, 2011

FDA has appealed the September 2011 ruling made by the U.S. District Court for the Middle District of Florida in U.S. v. Franck’s Lab, Inc. The ruling had favored pharmacy compounding for veterinary patients.

FDA has appealed the September 2011 ruling made by the U.S. District Court for the Middle District of Florida in U.S. v. Franck’s Lab, Inc. The ruling had favored pharmacy compounding for veterinary patients.

FDA had filed a lawsuit against Paul Franck, RPh, of Franck’s Lab in Ocala, Fla., alleging that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food-producing animals was illegal. To read more about the case, click here.

In the court’s decision, the International Academy of Compounding Pharmacists (IACP) said in a statement that Judge Timothy Corrigan ruled that:

  • FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy's activities are not manufacturing.  That rests with individual state Boards of Pharmacy.

  • When it enacted the Food, Drug and Cosmetic Act in 1938, Congress did not give FDA jurisdictional authority to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.

  • FDA cannot use its compliance policy guide for veterinary compounding issued in 2003 as the basis for enforcement action.

  • The regulations enacted by FDA based upon the Animal Medicinal Drug Use Clarification Act are in error - the act did not give FDA authority to prohibit the use of bulk APIs in veterinary compounding.

  • Size and scope of compounding do not mean that a pharmacy is a manufacturer.

  • The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food-producing animals is an illogical position for FDA to take and is contraindicated by its own actions over the past 50+ years.

"Despite Judge Corrigan's clear ruling that the FDA once again attempted to exceed its jurisdictional authority, the agency seems determined to waste taxpayers' money with another lengthy and unnecessary legal case," said IACP President John Herr, RPh, FIACP.  "Given its track record with other cases affecting compounding pharmacists, the FDA again refuses to recognize that both the U.S. Constitution and the U.S. Congress limit its role in the state-governed practice of medicine and pharmacy - a practice rightfully regulated by the state Boards of Pharmacy.”

David G. Miller, RPh, IACP executive vice president and CEO, said, "For 7 years, IACP and members of Congress continued to send a clear and simple message to the FDA … 'Fix the Veterinary Compounding Compliance Policy Guidance document.'  Had the FDA fulfilled its commitment to do so in 2004, this case would never have been brought to the courts in the first place. Think of all the money wasted by the FDA prosecuting a case which they have now lost twice, all the money wasted by Community Pharmacist Paul Franck in defending his business, all the money that will be spent on appeals and defense of appeals … simply because a government agency refused to solve a problem of their own creation. Despite rulings in other cases in addition to the recent US v. Franck Labs, Inc. and in language accompanying each of its own documents, the FDA appears unable to accept that its Compliance Policy Guidelines are not enforceable documents."