WASHINGTON, April 19 (UPI) — The U.S. Food and Drug Administration said it is seeking a federal injunction against a Florida company because of production of unsafe animal drugs.
The FDA said the injunction would stop Franck’s Compounding Lab of Ocala, Fla., 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 federal agency said in a statement.
The injunction would permanently bar the company — known as Franck’s Lab Inc. — and its chief executive officer, Paul Franck, from compounding animal drugs from bulk ingredients without FDA approval.
Officials said the company produces animal drugs from active pharmaceutical ingredients and distributes them nationwide. Compounding is the term used for combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.
“FDA recognizes the benefit of the traditional practice of pharmacy compounding,” said Dr. Bernadette Dunham, 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.”
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