Federal court upholds FDA removal of tirzepatide from shortage list

On May 7, 2025, a federal judge in the Northern District of Texas upheld the FDA's decision to remove two tirzepatide injection products from the agency's drug shortage list, a ruling that narrows the path for compounding pharmacies to make their own versions of the medicine sold as Mounjaro and Zepbound ^[1].

The decision came in Outsourcing Facilities Association v. FDA. The court concluded that the FDA acted within its statutory authority when it determined tirzepatide was no longer in shortage, and it emphasized the agency's discretion in managing the drug shortage list. The court also found that the plaintiffs had not shown sufficient harm to warrant judicial intervention ^[1].

The FDA has considered the tirzepatide shortage resolved since October 2024, despite objections from industry stakeholders. An attempt to pause that determination through a preliminary injunction failed in March 2025. The May 7 decision upheld the denial of that injunction ^[1].

Because the FDA now considers tirzepatide available, compounding pharmacies, outsourcing facilities and healthcare providers generally cannot rely on the shortage-list exception to compound "essentially copies" of tirzepatide injections. They must instead ensure their tirzepatide products are not substantially the same as commercially available products and are not administered by the same route ^[1].

Two transition periods have already closed. The FDA's discretionary period for 503A compounding pharmacies ended on February 18, 2025, and the period for 503B outsourcing facilities ended on March 19, 2025. During those windows, the FDA said it did not intend to take action against compounders for violations of the Food, Drug, and Cosmetic Act based on tirzepatide's earlier place on the shortage list. That general protection from enforcement is no longer in place ^[1]. Legal analysts describe the ruling as clearing the way for increased enforcement against noncompliant compounding practices ^[1].

The tirzepatide decision arrives as the supply picture for other GLP-1 medicines shifts. Semaglutide, the molecule in Ozempic, Wegovy and Rybelsus, has also been removed from the drug shortage data, suggesting the national shortage of certain GLP-1 medications appears to be coming to an end ^[1]. It has not been reported whether any court has ruled on the semaglutide removal.

Why it matters for patients

During the shortage, the FDA's shortage-list exception was one legal basis compounders used to make and sell versions of tirzepatide injections. With that exception effectively closed, the availability of compounded tirzepatide can change, and the clinics and pharmacies that supply it face a different set of rules ^[1].

FDA-approved tirzepatide injections remain on the market under the FDA's determination that the drug is available ^[1]. For people who have been getting tirzepatide from a compounding pharmacy, the practical questions are whether their pharmacy will keep offering it, how it will be formulated, and at what price. Those specifics have not been reported. The court ruling addresses the FDA's authority over the shortage list, not the terms of any individual patient's prescription.

Semaglutide was removed from the shortage data as well, so the same legal logic could affect compounded semaglutide supply ^[1]. What enforcement the FDA will actually pursue, against which compounders, and on what timetable has not been disclosed.

What happens next

The key dates so far are behind us: tirzepatide was classified as resolved in October 2024, the 503A discretionary period ended February 18, 2025, the 503B period ended March 19, 2025, and the court ruling came May 7, 2025 ^[1]. No further court dates, FDA enforcement deadlines, or rulemaking steps have been announced ^[1].