A US federal district court denied a preliminary injunction on May 30, 2025 in a case brought by a coalition of compounding pharmacies seeking to reverse FDA's October 2024 removal of tirzepatide from the Drug Shortages list. The plaintiffs argued that FDA's delisting was arbitrary in light of continued patient demand and reported regional supply variability.
The court declined to grant the injunction but allowed the case to proceed on the merits. The ruling does not change the operational reality on the ground: compounded tirzepatide preparation under the broad shortage exception remains closed, with continued compounding limited to documented-medical-necessity grounds at the prescriber level.
The case is being watched as a test of FDA's procedural latitude in shortage-list decisions and may shape how the agency handles future delistings.