Court rules in favor of veterinary compounding pharmacy; judge says FDA overstepped its authority

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Sep 15, 2011
Ocala, Fla. — The U.S. Food and Drug Administration lost its first attempt at shutting down a veterinary compounding operation Sept. 12, when a U.S. District Court denied its motion for a permanent injunction against Franck’s Pharmacy of Ocala, Fla.

“Obviously we’re very happy with the opinion of the judge,” says Paul Franck, RPh, FIACP, chief executive office and owner of Franck’s Pharmacy. “But it’s really good for all compounders so we have a better understanding now of what we can and can’t do legally.”

Attention was brought to Franck’s compounding practices in April 2009, after medication error that resulted in high doses of selenium concentration killed 21 polo ponies from Venezuela at the U.S. Open Polo Championship. Franck’s had prepared the compounded medication for the polo team’s veterinarian. Neither the veterinarian nor Franck’s noticed the mathematical error in the conversion of an ingredient that lead to the compounding error.

The suit, filed in U.S. District Court for the Middle District of Florida, claimed that animal medications compounded from bulk ingredients could not be distributed without an FDA-approved new animal drug application. But Franck’s argued that the traditional, state-licensed practice of compounding commercially unavailable veterinary medications from bulk ingredients is a legal practice followed by licensed pharmacies across the nation.

Franck’s voluntarily stopped compounding veterinary drugs in May 2010 following the FDA’s filing, but resumed in August 2010 after the court denied the agency’s motion for a temporary injunction.

In his Sept. 12 decision in favor of summary judgment for Franck’s Pharmacy and denying FDA’s motion for a permanent injunction, U.S. District Judge Timothy J. Corrigan writes “FDA has long been on notice that its statutory authority to regulate traditional, state-licensed veterinary pharmacy compounding was questionable … It has decided to proceed with this enforcement action, asserting a ‘maximalist’ interpretation of its authority.”

Read more in the October issue of DVM Newsmagazine.