Fifth Circuit upholds FDA removal of tirzepatide from shortage list

The Fifth Circuit Court of Appeals has upheld the FDA's decision to remove tirzepatide injection products from the federal drug shortage list, affirming a lower court and closing the compounders' main legal route back to shortage-based mass compounding of the drug ^[1]. The unpublished per curiam opinion in No. 25-10600 was filed August 27, 2026, by a panel of Judges Richman, Duncan and Oldham ^[1].

The plaintiffs are the Outsourcing Facilities Association and North American Custom Laboratories, doing business as FarmaKeio Custom Compounding ^[1]. They argued the FDA violated the Administrative Procedure Act in two ways: by not using notice-and-comment rulemaking before delisting the drugs, and by reaching a shortage determination that was arbitrary and capricious ^[1]. Eli Lilly, which makes Mounjaro and Zepbound, intervened on the FDA's side ^[1].

The court assumed, without deciding, that the FDA erred by skipping notice and comment, then concluded the compounders had not shown prejudice, making any such error harmless ^[1]. It also concluded the FDA's shortage determination was not arbitrary or capricious ^[1].

The FDA added Mounjaro to its shortage list in December 2022 and Zepbound in April 2024 ^[1]. On October 2, 2024, the agency posted that the tirzepatide injection shortage was resolved; after a voluntary remand, it confirmed on December 19, 2024 that Eli Lilly's supply would "meet or exceed projected demand" ^[1]. While the products were on the list, Eli Lilly spent approximately $23 billion expanding manufacturing capacity in the United States and Europe and won FDA approval to sell single-dose vials in addition to the pens already approved ^[1].

The FDA memorialized its decision in a Declaratory Order and Decision Memorandum, describing the action as an informal adjudication with notice published on its website and an opportunity for affected parties to submit information ^[1]. The agency said Eli Lilly, individual patients, pharmacy compounders, outsourcing facilities, associations representing them, and telehealth companies did submit information, and that it would not take action against compounders for 60 or 90 days depending on the type of compounder to allow an orderly transition ^[1].

A companion opinion, No. 25-10758, resolved the semaglutide appeal the same day, affirming the delisting of Ozempic and Wegovy for the same reasons: any notice-and-comment error was harmless, and the action was not arbitrary or capricious ^[4]. There, the FDA relied on Novo Nordisk's production and inventory data, including quantities supplied and demanded, inventory held for all strengths, projected supply and demand, and wholesaler inventory data, while also considering information from telehealth companies, compounders, associations and individuals ^[4]. The FDA concluded Novo Nordisk's data had more probative value ^[4].

A law firm analysis of the two rulings notes that the FDA discounted information collected through a Hims & Hers website because the submissions did not reliably establish when the reported access problem occurred, where the user was located, why the individual could not obtain the drug, or whether the same person submitted multiple reports, and that the Fifth Circuit found the FDA reasonably treated manufacturer data as more probative ^[3]. Both opinions are unpublished ^[1][4].

Why it matters for patients

Compounded versions of these drugs, made by pharmacies rather than Eli Lilly or Novo Nordisk, were widely sold while the shortages lasted ^[3]. Once a product is off the shortage list, federal law generally bars physicians, pharmacies and outsourcing facilities from compounding drugs that are essentially copies of approved products, which the court said made compounding of tirzepatide injection products unlawful ^[1]. The law firm analysis states that compounding pharmacies can no longer rely on the former shortages to support routine large-scale production of essentially copies of the approved products ^[3].

That analysis adds that legitimate patient-specific compounding is not eliminated: Section 503A still permits compounding for an identified patient when statutory requirements are met, and federal law recognizes situations where a prescriber determines a compounded product makes a significant difference for a particular patient ^[3]. It also notes that a patient-specific prescription by itself does not resolve whether a product is essentially a copy ^[3].

What happens next

The FDA's semaglutide and tirzepatide shortage determinations remain in place following the rulings ^[3]. Eli Lilly's exclusive right to manufacture tirzepatide products extends to 2027 ^[1]. It has not been reported whether the compounders will ask for further review, such as a rehearing or a petition to the Supreme Court.