FDA to appeal Francks veterinary compounding ruling

The U.S. Food and Drug Administration is appealing the decision of a Florida District Court that ruled the FDA overstepped its authority when it attempted to shut down a veterinary compounding facility.

In 2010, the FDA originally sought a permanent injunction against veterinary compounding facility Franck’s Lab, Inc., alleging that the use of active pharmaceutical ingredients in compounding veterinary preparations for non-food producing animals was illegal.

In September, a Florida District Court ruled that Congress did not give the FDA the ability to take enforcement action against a pharmacy engaged in the traditional practice of compounding. The court also ruled that the 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.

John Herr, R.Ph., FIACP, is president of the International Academy of Compounding Pharmacists (IACP). The IACP is a non-profit association that represents compounding pharmacists and technicians.

Herr released a statement on behalf of the IACP following the FDA’s appeal:

"For seven 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," Herr said. "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."

Trends Today will continue to follow this story as it develops.

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