Court refuses to block the tirzepatide delisting

A federal district court in Texas denied a request for a preliminary injunction on March 5, 2025, in Outsourcing Facilities Association v. FDA, case number 4:24-cv-00953 (N.D. Tex.) ^[1]. The ruling let the Food and Drug Administration's timeline for phasing out special compounding allowances for tirzepatide take effect. Tirzepatide is the active ingredient in Mounjaro and Zepbound ^[1].

The case traces back to FDA's declaration that the tirzepatide shortage was resolved. FDA first made that call, then reevaluated it after litigation forced a remand on October 22, 2024, and on December 19, 2024 issued a new decision again finding the shortage resolved ^[1]. Normally, once a shortage ends, pharmacies and outsourcing facilities lose the ability to keep making copycat versions of the drug. To soften the transition, FDA said it would not enforce this cutoff right away, giving state-licensed pharmacies and physicians compounding under section 503A of federal law until February 18, 2025, and giving FDA-registered outsourcing facilities compounding under section 503B until March 19, 2025 ^[1].

The Outsourcing Facilities Association sought a court order to block those deadlines. On February 11, 2025, FDA clarified that its enforcement discretion would run until whichever came later: the stated deadline or the date of the court's ruling on the injunction request ^[1]. When the court denied that request on March 5, 2025, FDA said the enforcement discretion period for 503A pharmacies and physicians had already ended, while outsourcing facilities under 503B still had until March 19, 2025 before FDA said it would begin taking action over shortage-related violations ^[1].

A similar legal fight played out for semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus. FDA had declared the semaglutide shortage resolved on February 21, 2025, and set parallel deadlines of April 22, 2025 for 503A compounders and May 22, 2025 for 503B outsourcing facilities ^[1]. A separate injunction request in that case, filed as 4:25-cv-00174 (N.D. Tex.), was also denied, on April 24, 2025, ending 503A enforcement discretion for semaglutide as well ^[1].

Why it matters for patients

Patients who get compounded tirzepatide from a state-licensed compounding pharmacy or physician were affected as soon as the March 5, 2025 ruling came down, since FDA said enforcement discretion for those compounders had already ended ^[1]. Patients who instead relied on an FDA-registered outsourcing facility had a few more weeks, until March 19, 2025 ^[1]. FDA has repeated that it can still act against any compounder, regardless of shortage status, if it finds a product is substandard or unsafe ^[1]. As of an FDA update dated April 1, 2026, neither tirzepatide nor semaglutide appears on the agency's list of bulk substances that outsourcing facilities may use, and neither is on the current drug shortage list, which further limits when 503B compounding of these drugs is allowed ^[1]. What this means for the day-to-day cost or availability of compounded products at individual pharmacies is not addressed in the available FDA materials.

What happens next

FDA said enforcement discretion for outsourcing facilities compounding tirzepatide under section 503B ended March 19, 2025 ^[1]. The parallel semaglutide case concluded later, with the court denying an injunction on April 24, 2025 and FDA's 503B enforcement discretion for semaglutide outsourcing facilities running until May 22, 2025 ^[1]. FDA has said it continues to monitor compounding activity and may pursue action for quality or safety violations independent of shortage status ^[1].