The 5th U.S. Circuit Court of Appeals affirmed Aug. 27 that the FDA acted lawfully when it declared Eli Lilly’s tirzepatide shortage resolved, according to court documents reviewed by Becker’s The ruling delivers a defeat to compounding pharmacies that had sued to keep making cheaper, unapproved versions of Mounjaro and Zepbound.
Here are five things to know:
- The FDA first declared the tirzepatide shortage over Oct. 2, 2024, then reversed course three weeks later after the Outsourcing Facilities Association sued and public pressure mounted. The agency reaffirmed the delisting in December 2024.
- Eli Lilly joined Outsourcing Facilities’ lawsuit in January 2025 to defend the FDA’s decision. The Outsourcing Facilities Association and Farmakeio Custom Compounding argued the agency should have used formal notice-and-comment rulemaking and that its shortage determination was arbitrary and capricious.
- The 5th Circuit rejected both arguments. It found the compounders had actual notice and a real chance to weigh in — the FDA’s reevaluation period ran nearly 60 days, double the Administrative Procedure Act’s standard comment window — so any procedural misstep was harmless. On the merits, the panel said the FDA reasonably relied on Eli Lilly’s supply data, which showed an 11.6 million-dose surplus by November 2024 after about $23 billion in manufacturing investment, over less-reliable evidence such as wholesaler screenshots and patient surveys.
- A parallel case over Novo Nordisk’s semaglutide products, filed in February 2025, is pending before the same panel.
- The tirzepatide ruling lands amid a broader FDA-Lilly push against compounders. The FDA told pharmacies in April 2026 to stop compounding GLP-1s once brand versions clear the shortage list, and Lilly has separately raised safety concerns about compounded tirzepatide-B12 products, claims the Alliance for Pharmacy Compounding has disputed.
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