On September 12, 2011, the United States District Court for the Middle District of Florida entered an order denying the U.S. Food and Drug Administration’s request for an injunction barring Franck’s Lab, a Florida based pharmacy, from engaging in traditional, state- licensed bulk compounding of animal drugs and granting Franck’s motion for summary judgment. See United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla.). The United States brought this first-of-its-kind enforcement action on the novel theory that all animal medications compounded from bulk ingredients are “new animal drugs” requiring FDA approval under the Food, Drug, and Cosmetic Act (FDCA). The Court rejected FDA’s position and, ruling in Franck’s favor on all issues, held that FDA lacked authority “to enjoin the long-standing, widespread, state regulated practice of pharmacists filling a veterinarian’s prescription for a non food-producing animal by compounding from bulk substances.”

Judge Timothy J. Corrigan’s scholarly and comprehensive 80-page opinion has significant ramifications for all FDA-regulated industries because it rejects FDA’s reliance on non-binding guidances and makes clear that FDA’s enforcement discretion is limited by substantive and procedural legal rules. The rule that FDA sought to enforce against Franck’s—that compounding animal medications from bulk ingredients in accordance with state law is a per se violation of the FDCA—is not clearly stated in the statute itself, and FDA has never created such a rule through notice-and-comment rule making. Judge Corrigan held that FDA therefore lacks authority to enforce such a rule in an injunctive action.

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