Fifth Circuit upholds FDA decisions ending semaglutide and tirzepatide shortages

A federal appeals court has upheld the FDA's decisions ending the shortages of semaglutide and tirzepatide, keeping both medicines off the national drug shortage list ^[1].

The August 27 ruling from the US Court of Appeals for the Fifth Circuit covers semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus, and tirzepatide, the ingredient in Mounjaro and Zepbound ^[1]. The National Consumers League, which says it works on GLP-1 safety issues, welcomed the outcome ^[1].

At the center of the case is a rule that has governed compounding for decades. Tied to the Food and Drug Administration Modernization Act, it lets compounding pharmacies turn out temporary versions of commercially sold drugs while supplies run short — but continued mass production and sale of those copies becomes illegal once the shortage is over ^[1].

The Outsourcing Facilities Association, a trade group representing compounding pharmacies, sued over the two shortage decisions. According to the consumer group's account, the association argued that the FDA was cutting patients off from needed treatment and artificially raising prices, that the agency dismissed evidence the shortages were still going on, and that compounders got neither reasonable notice of the agency's plans nor a chance to comment ^[1].

The appeals court turned those arguments down. It found the FDA stayed inside the statutory framework and applied the statutory definition of shortage to the evidence in front of it ^[1]. The court also backed how the agency reached its conclusions, favoring actual supply figures from the manufacturers over the material compounders submitted — pharmacy screenshots, patient reports, news articles, blog posts and form letters — which the court treated as less probative ^[1].

The market involved is large. Compounded products accounted for an estimated 30% of the overall GLP-1 weight-loss market in 2024, according to the consumer group ^[1].

Why it matters for patients

For people who have been using a compounded version of semaglutide or tirzepatide, often obtained through telehealth services or online pharmacies, the ruling keeps the FDA's position intact: the shortages that once opened the door to large-scale compounding of these two drugs are treated as finished, and that opening has not been restored ^[1].

What the decision does not settle is just as relevant. The statement does not address what the brand-name products cost, whether insurers cover them, or how well supplied they are ^[1]. It also does not say what telehealth companies plan to offer patients who have been getting compounded versions; those plans have not been reported.

The ruling is specific to semaglutide and tirzepatide. It does not cover other GLP-1 medicines, and the dispute concerned the FDA's shortage determinations rather than an assessment of whether compounded copies are safe or effective ^[1].

What happens next

The consumer group described the decision as a marker for policymakers and compounders, and said the FDA's shortage framework has held up because it leans on specific, reliable, comprehensive and current supply data from along the product supply chain ^[1]. No further court dates, deadlines or enforcement steps have been disclosed, and it has not been reported whether the compounding association will seek additional review ^[1].