District court rules in favor of veterinary compounding pharmacy

Judge says FDA overstepped its authority
source-image
Oct 01, 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.

Animal and veterinary drug compounding accounts for about 40 percent of the business at Franck's—which has been compounding medicals for humans and animals since 1985, according to court records. The company receives orders from all over the country and holds valid pharmacy licenses in 47 states, filling roughly 37,000 animal-drug prescriptions annually.

FDA scrutiny first surfaced against Franck's in January 2005, when the agency sent the company a warning letter expressing concern that the pharmacy was manufacturing drugs and that compounding was being performed outside the context of a valid veterinarian-client-patient relationship. Franck's worked with the FDA to address its concerns and continued compounding as usual until the agency filed suit against the compounding pharmacy in April 2010.

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.