Compounders sue FDA over tirzepatide shortage list removal
The lawsuit paused enforcement deadlines for compounded copies of Mounjaro and Zepbound and previewed the legal fight that followed semaglutide's removal from the same shortage list.
The Outsourcing Facilities Association and North American Custom Laboratories, LLC, which does business as Farmakeio Custom Compounding, sued the FDA in the U.S. District Court for the Northern District of Texas on October 7, 2024, over the agency's decision to remove tirzepatide injection products from its drug shortage list [1][3]. The suit, No. 4:24-cv-953, came days after the FDA posted on October 2, 2024 that the shortage of tirzepatide injection products was resolved [1][2].
Tirzepatide is the active ingredient in Mounjaro, approved in May 2022 for type 2 diabetes, and Zepbound, approved in November 2023 for obesity and weight-related conditions [1]. Mounjaro was added to the shortage list in December 2022 and Zepbound in April 2024, both because of high demand [1][2]. A drug's place on that list temporarily suspends federal limits on compounding copies of it. Once tirzepatide came off the list, it became unlawful for physicians, pharmacies and outsourcing facilities to compound tirzepatide injection products [2].
On October 11, 2024, at the FDA's request, a court order sent the decision back to the agency for re-evaluation [1]. The FDA issued a new declaratory order on December 19, 2024 that revoked and replaced the October 2 decision and again concluded the shortage was resolved [1]. The agency said data from Eli Lilly, the maker of Mounjaro and Zepbound, showed supply was "currently meeting or exceeding demand" and would meet or exceed projected demand [1]. Lilly has said it spent approximately $23 billion to build and expand manufacturing capacity [2]. The order set compliance windows for compounders: 60 calendar days for state-licensed pharmacists and physicians compounding under section 503A, until February 18, 2025, and 90 days for 503B outsourcing facilities, until March 19, 2025 [1]. During those periods, the FDA said it did not intend to take action against compounders for violations tied to the drug's shortage-list status [1].
The FDA also said it heard from patients, pharmacists and compounders who reported that people could not get the approved drugs and that substantial tirzepatide compounding was occurring [1]. The agency said that information had important limitations and did not outweigh Lilly's data. It added that some patients may still face intermittent, localized supply problems after a shortage is declared over, because of how product moves from manufacturers through wholesalers to pharmacies [1].
The case continued for nearly two years. In an opinion filed August 27, 2026, the Fifth Circuit Court of Appeals affirmed the district court, which had ruled for the FDA and Lilly [2]. The appeals court assumed without deciding that the FDA erred by not using notice-and-comment rulemaking, but concluded the compounders had not shown prejudice. It also found the FDA's shortage determination was not arbitrary or capricious [2]. The court noted Lilly's exclusive right to manufacture tirzepatide products extends to 2027 [2].
Semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus, followed a similar path. The FDA removed semaglutide from the shortage list on February 21, 2025, with grace periods ending April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities [3][4]. That action is separate from the tirzepatide case and did not change the tirzepatide deadlines, which at that point depended on the district court's ruling in the tirzepatide lawsuit [3].
Why it matters for patients
The litigation shaped when compounded copies of tirzepatide, and later semaglutide, could still legally be made. Compounded drugs are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality before they reach patients [2]. With the shortage declared over, the legal supply of compounded tirzepatide injection products narrowed to a 60-day or 90-day window depending on the compounder [1]. The FDA has said it will keep monitoring supply and demand and can add products back to the shortage list if needed [1], and it acknowledged that patients may still encounter intermittent local supply disruptions even though a shortage is resolved [1]. What patients who currently use compounded versions would pay for the approved products, or whether insurance would cover a switch, has not been reported.
What happens next
It has not been reported whether the compounders appealed further after the August 27, 2026 Fifth Circuit ruling [2]. Separately, Eli Lilly has petitioned the FDA to place tirzepatide on its list of drugs with demonstrable difficulties for compounding, and Novo Nordisk has nominated semaglutide for the same list; if granted, that step would bar pharmacists, physicians and outsourcing facilities from compounding them [4]. A decision date on those petitions has not been disclosed [4].
Sources
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