Medical Center Pharmacy v. Mukasey

JERRY E. SMITH, Circuit Judge:

In this appeal we clarify the extent to which the Federal Food Drug and Cosmetic Act of 1938 (the “FDCA” or the “Act”), 21 U.S.C. §§ 301-397, permits the Food and Drug Administration (“FDA”) to regulate a common practice of pharmacies known as “compounding.” Ten pharmacies specializing in compounding prescription drugs for human and animal use (the “Pharmacies”) sued various federal agencies (collectively, the “FDA”) for declaratory and injunctive relief permitting them to continue compounding drugs without obtaining the FDA approval required for “new drugs”…