Franck’s Compounding Lab of Ocala, Fla., reported today that it has resumed its veterinary compounding practice, effective immediately, after voluntarily suspending it in May.
Franck’s decision comes shortly after a federal judge denied a U.S. Food and Drug Administration request for a preliminary injunction that would have shut down the veterinary compounding business.
“Veterinary compounding is a longstanding, recognized and medically vital service,” Paul Franck, owner of Franck’s Compounding Lab, said in a prepared statement. “We are resuming this practice so that we can help veterinarians and pet owners who rely on compounded medicines to stay healthy and treat life-threatening conditions. We have been compounding human and veterinary medications for more than 27 years and we are as committed as ever to meeting the special needs of doctors, veterinarians and their patients.”
However, the FDA’s complaint is not being dismissed entirely. The court just was not convinced at this preliminary stage that the FDA’s legal theory was correct and that a preliminary injunction was warranted, according to Franck’s.
The FDA maintains that animal medications compounded from bulk ingredients constitute “new animal drugs” that cannot be distributed without an FDA-approved new animal drug application.
Franck’s contends that “the traditional, state-licensed pharmacy practice of compounding commercially unavailable veterinary medications from bulk ingredients is lawful.”
Franck’s had voluntarily suspended all compounding drugs for veterinary use in May when the FDA first announced that it was seeking a permanent injunction against the company’s veterinary compounding practice. Franck’s had said that it would suspend its veterinary compounding pending the outcome of discussions with the FDA.
The FDA’s lawsuit does not apply to Franck’s human compounding practice.
Franck’s drew media attention when 21 polo horses died shortly before the U.S. Open Polo Championship in Palm Beach County, Fla., in April 2009. Franck’s admitted that it incorrectly prepared medication used to treat the horses.