Medical Center Pharmacy v. Mukasey

The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) gave the Food and Drug Administration (FDA) the power to require approval for any new drug. A new drug was defined as a drug for which the composition is not generally recognized as safe and effective, meaning it had not yet gone through an extensive application and approval process. The FDCA also permits the FDA to regulate the practice of drug compounding. Drug compounding is when pharmacists either combine or alter drug ingredients according to a doctor’s prescription to meet the needs of an individual human or animal patient. For approximately 50 years after the FDCA was enacted, compounded drugs were not explicitly considered to be new drugs under the FDCA and pharmacists were permitted to compound drugs without seeking FDA approval. The classification of compounded drugs was addressed when Congress amended the FDCA with the Food and Drug Modernization Act of 1997 (FDAMA). The FDAMA created a safe harbor from the FDCA’s new-drug approval requirements for drug compounding. The FDAMA required compounding pharmacists to follow several requirements to ensure that the pharmacist was engaged in traditional compounding rather than disguised manufacturing. In 2002, the Supreme Court invalidated advertising-related provisions of the FDAMA but declined to address the validity of the remaining portions. In response, the FDA issued revised Compliance Policy Guides that declared the entire FDAMA invalid and explicitly subjected compounded drugs to the new-drug approval requirements. Ten pharmacies (the pharmacies) (plaintiffs) sued various federal agencies (the FDA) (defendant) for declaratory and injunctive relief permitting them to continue compounding drugs without requiring FDA approval. The pharmacies argued that the FDAMA was still valid and that compounded drugs are not new drugs and therefore not subject to the new-drug approval requirements imposed by the FDCA. The district court agreed with the pharmacies and held that the FDAMA was valid and that compounded drugs are not new drugs.