FDA files notice of appeal over veterinary compounding ruling

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Nov 18, 2011
Ocala, Fla. — The federal government appealed the September decision of a Florida district court that ruled the U.S. Food and Drug Administration overstepped its authority when it tried to shut down a veterinary compounding pharmacy.

A notice of appeal filed in the U.S. District Court for the Middle District of Florida Nov. 10 gives no detail about why the court’s earlier decision is being appealed, nor does it indicate when an official appeal will be filed.

The Department of Justice could not be reached for comment by press time.

Paul Franck, owner of Franck’s Pharmacy, says he doesn’t have much to say about the notice, referring DVM Newsmagazine instead to a statement released by the International Academy of Compounding Pharmacists (IACP).

“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,” says IACP President John Herr, RPh, FIACP.

"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. Think of all the money wasted by the FDA prosecuting a case that they have now lost twice ... 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," adds IACP Executive Vice President and Chief Executive Officer David G. Miller, RPh.

FDA scrutiny first surfaced against Franck’s Pharmacy in January 2005. The agency sent 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 its operations 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 the pharmacy resumed in August 2010 after the court denied the agency's motion for a temporary injunction.

In a 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."

FDA failed to back up other claims against Franck's, including allegations of compounding commercially available drugs or compounding drugs in advance of a valid prescription, Corrigan wrote.

Hundreds of pharmacies compound animal medications from bulk ingredients, governed by state regulations, without interference from FDA, Corrigan adds.

"Allowing the FDA to enjoin a pharmacist's traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without the necessary medication," he writes. "Such a result would be especially troublesome because the FDA's longstanding policy has been to permit, and even promote, pharmacists' compounding from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without explanation, especially where its asserted expansion of authority impacts the federal-state balance and potentially subjects many individuals and companies to criminal liability."