backIn 2025, federal district and appellate courts have rejected claims by drug compounders that FDA’s removal of certain drugs from its “shortage list” was unlawful and state law unfair trade practices claims by drug manufacturers against compounders are preempted by the FDCA. In a still-pending case, the Outsourcing Facilities Association (a 503B compounder trade association) has argued that FDA lacks discretion to exclude from the “clinical needs” list (for which bulk use in 503B facilities is allowed) any drug substance that is an active pharmaceutical ingredient in an FDA-approved drug.
This presentation offers an up-to-the-minute recap concerning these major drug compounding cases, as well as an overview of trends in private enforcement through state unfair trade practices of statutes.
For questions, or for information about registration, contact Sydney Forte.