Compound Animal Drugs Not Under FDA Authority: Court

Law360, New York (September 12, 2011, 6:08 PM EDT) -- The U.S. Food and Drug Administration overstepped its authority when it tried to stop a Florida pharmacy from making compound prescription drugs for animals, a federal judge ruled Monday.

Mixing bulk drug ingredients into custom medications at the request of veterinarians, known as compounding, is a “long-standing, widespread, state-regulated practice” that the FDA does not have the authority to regulate, U.S. District Judge Timothy J. Corrigan said.

He granted a motion for summary judgment filed by the pharmacy, Ocala-based Franck's Lab Inc. The pharmacy compounds both...
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