Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without premarket approval

The Federal Food, Drug, and Cosmetic Act (“FDCA”) authorizes manufacturers known as “outsourcing facilities” to market compounded drugs without obtaining premarket approval from the Food and Drug Administration (“FDA”) and generally preempts enforcement of the Act’s requirements other than by the Federal Government. See Buckman Co. v. Plaintiff’s Legal Committee , 531 U.S. 341, 352 (2001). In conflict with decisions of the First and Ninth Circuits, the decision below by the Fifth Circuit held that state-law claims by private parties to enforce the Act’s premarket-approval requirement against outsourcing facilities for marketing compounded drugs are not preempted. Accordingly, the question presented is: Whether the FDCA preempts private state-law unfair competition and consumer protection claims premised on the marketing of compounded drugs without premarket approval.