Franck’s Compounding Lab of Ocala, Fla., reported May 17, 2010 that it has voluntarily suspended all compounding drugs for veterinary use, pending the outcome of discussions with the U.S. Food and Drug Administration.
“Customized veterinary medicine — which we had prepared pursuant to a verified prescription – meet the critical needs of veterinarians and their patients,” the company said in a statement. “We are working with the FDA to resolve this issue as quickly as possible to determine whether it will permit us to resume compounding of these important veterinary medicines.”
The FDA is currently seeking a permanent injunction against the company to prohibit Franck’s and its CEO Paul Franck from compounding animal drugs from bulk ingredients without FDA approval. The U.S. Department of Justice filed the civil suit on behalf of the FDA mid April alleging that the company has been introducing adulterated, misbranded and unsafe drugs into interstate commerce as part of the company’s veterinary pharmaceutical compounding business.
Franck’s maintains that its business is both legal and medically vital.
The company 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.
Despite the voluntary suspension of its veterinary drug compounding, most of Franck’s customers will be unaffected, according to the company, as it will continue to compound all human medicines.
Franck’s employs about 67 people, has annual gross sales of about $8 million—$3.5 million from veterinary products—and filled more than 37,600 prescriptions for animal use between Feb. 1 and Dec. 4, 2009, according to the FDA.