Fifth Circuit upholds FDA rulings that semaglutide and tirzepatide shortages have ended

The Fifth Circuit has upheld the FDA's decisions that the shortages of semaglutide and tirzepatide injection drugs have ended, closing the main legal path compounding pharmacies used to make large volumes of copies of Ozempic, Wegovy, Mounjaro and Zepbound ^[1]. The tirzepatide opinion was issued August 27, 2026 by a three-judge panel, which said it was issuing separate opinions in the two appeals ^[2].

Federal law generally bars compounding of drugs that are essentially copies of approved products, but that restriction is suspended while a drug is on the FDA's shortage list ^[1][2]. The FDA removed tirzepatide injection products from the list in October 2024 and confirmed on December 19, 2024 that the shortage was resolved, concluding that Eli Lilly's supply would meet or exceed projected demand ^[2]. For semaglutide, the FDA relied heavily on Novo Nordisk's production, inventory, supply, wholesaler and projected demand information; for tirzepatide it cited Lilly's expanded manufacturing capacity and information from manufacturers, compounders, patients, healthcare professionals, telehealth companies and others ^[1]. The FDA allowed transition periods of 60 or 90 days, depending on the type of compounder, before resuming enforcement ^[2].

The plaintiffs, the Outsourcing Facilities Association and North American Custom Laboratories, which does business as FarmaKeio Custom Compounding, argued that the FDA should have used notice-and-comment rulemaking and that its shortage determination was arbitrary and capricious ^[2]. The court assumed without deciding that the FDA erred procedurally but found no prejudice, because affected parties had actual notice and repeated chances to submit information ^[1][2]. It held that the shortage determination was not arbitrary or capricious and that the FDA reasonably relied on manufacturer supply and inventory data ^[1][2].

The court also upheld the FDA's treatment of screenshots, patient reports, surveys and news articles offered to show that shortages persisted ^[1]. In the tirzepatide case, the FDA discounted information collected through a Hims & Hers website because it did not reliably establish when the reported access problem occurred, where the user was located, why the person could not get the drug, or whether the same person submitted multiple reports ^[1].

Eli Lilly spent approximately $23 billion to expand manufacturing capacity ^[2]. Mounjaro was approved in May 2022 and Zepbound in November 2023, and they are the only FDA-approved tirzepatide products; Lilly's exclusivity runs to 2027 ^[2].

Patient-specific compounding under Section 503A continues to be permitted, but on a narrower footing ^[1]. A prescription for an identified patient is an important part of that pathway, but a patient-specific prescription by itself does not resolve whether the compounded product is essentially a copy or whether the other statutory conditions are satisfied ^[1].

Why it matters for patients

Compounded semaglutide and tirzepatide became a large market while the brand-name drugs were scarce, sold through compounding pharmacies, telehealth companies, weight-loss businesses, medical practices, med spas and online platforms ^[1]. With the shortage exception no longer available, compounders cannot rely on the former shortages to support routine large-scale production of essentially copies of the approved products ^[1]. That can affect which compounded products are offered, how they are prescribed and marketed, and how pharmacy, prescriber and telehealth relationships are arranged ^[1]. The FDA can examine a formulation, prescribing documentation, medical justification, pharmacy operations and marketing when determining whether a program satisfies federal compounding requirements ^[1].

Both opinions were issued unpublished, and the Fifth Circuit decisions apply settled precedent to these challenges; courts considering materially similar challenges would be expected to reach the same result absent different facts, a different administrative record or a different legal theory ^[1]. The decisions do not eliminate legitimate patient-specific compounding, and they do not address whether any particular product or program is lawful ^[1]. Whether specific telehealth programs will stop selling compounded GLP-1 products, and how patients now using them will be affected, has not been reported.