The Food and Drug Administration is seeking an injunction in federal court against Franck’s Compounding Lab of Ocala, Fla., to prevent the company from introducing adulterated, misbranded, and unsafe animal drugs into interstate commerce.
The FDA is concerned that the company’s continued compounding practices pose a significant public health risk, as evidenced by the deaths of 21 polo ponies April 19, 2009, before a match in the U.S. Open Polo Championships, after having been given a drug compounded by Franck’s.
The complaint for the injunction was filed April 16 by the Department of Justice on behalf of FDA in the U.S. District Court for the Middle District of Florida and would permanently bar the company, officially known as Franck’s Lab Inc., and its chief executive officer, Paul W. Franck, from compounding animal drugs from bulk ingredients without FDA approval.
The compounding pharmacy makes animal drugs, in most instances from active pharmaceutical ingredients (“bulk ingredients”), and distributes them throughout the country. Compounding is the term used for combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.
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Animal drugs compounded from bulk ingredients do not undergo FDA review and are not approved by the agency. Many of Franck’s illegal products are copies very similar to available drugs that have been approved by FDA.
“FDA recognizes the benefit of the traditional practice of pharmacy compounding -- providing a service in response to a valid prescription to accommodate the specialized needs of a particular patient,” said Bernadette Dunham, D.V.M., Ph.D., director of the agency’s Center for Veterinary Medicine. “But when compounders like Franck’s circumvent, and thus undermine, the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding, we are concerned that poorly compounded drugs can jeopardize the health of animals.”
Franck’s has been inspected and warned about its illegal behavior, as recently as December 2009, but it has failed to cease its illegal practices.