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Case Detail


United States v. Franck’s Lab, Inc.
On April 6, 2012, WLF filed a brief in the U.S. Court of Appeals for the Eleventh Circuit, urging it to prevent FDA from adopting new rules that would, in effect, criminalize the activities of a significant percentage of pharmacies in this country. WLF argued that the “compounding” of drugs by pharmacists has long been regulated by the States, not the federal government, and that Congress never intended to authorize FDA to prohibit compounding. WLF further argued that even if FDA were so authorized, it may not implement its new anti-compounding rules without first complying with notice-and-comment rulemaking requirements. WLF’s brief recognized that some pharmacists engage in the large-scale manufacture of new drugs under the guise of compounding, and that FDA has authority to prevent such activity. But FDA is exceeding its powers when it asserts that all compounding of animal drugs violates federal laws, even when done only in response to a veterinarian’s prescription, WLF argued.
Case Status:
FDA's appeal dismissed following parties' settlement.
More Information and Downloads:
4/6/2012: Download the Brief

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