FDA Seeks Injunction Against Florida Animal Drug Compounder

April 29, 2010 2:59 pm Topics: Compounding

Food and Drug Administration (FDA) is seeking an injunction in federal court against Franck’s Compounding Lab of Ocala, FL, to prevent the company from introducing adulterated, misbranded, and unsafe animal drugs into interstate commerce, as reported in an FDA News Release. On April 19, 2009, 21 polo ponies that were administered a drug compounded by Franck’s died before a match in the United States Open Polo Championships, and FDA is concerned that the company’s continued compounding practices pose a significant public health risk. The complaint for the injunction would permanently bar the company from compounding animal drugs from bulk ingredients without FDA approval. Animal drugs compounded from bulk ingredients do not undergo FDA review and are not approved by the agency. FDA reports that many of this compounder’s illegal products are copies very similar to available drugs that have FDA approval, and the agency is concerned that the company’s poorly compounded drugs could jeopardize the health of animals.