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# Court Upholds FDA Shortage Resolution Decision on Lilly’s Tirzepatide
- URL: https://www.fdaweb.com/court-upholds-fda-shortage-resolution-decision-on-lillys-tirzepatide/
- Published: 2026-08-27T12:00:00.000Z
- Updated: 2026-09-14T12:05:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161693

The U.S. Court of Appeals for the Fifth Circuit has upheld FDA’s decision to remove tirzepatide from the agency’s drug shortage list, a ruling that limits the ability of pharmacies and compounding facilities to produce versions of the popular drugs.

The case involved Eli Lilly’s Mounjaro and Zepbound, which both contain the active ingredient tirzepatide. FDA determined in late 2024 that a national shortage of tirzepatide injections had been resolved, citing increased manufacturing capacity and evidence that Lilly’s supply would meet or exceed projected demand. The decision effectively ended the statutory exception that had allowed compounders to make tirzepatide products despite federal restrictions against compounding drugs that are essentially copies of commercially available medications.

Outsourcing Facilities Association and a Texas compounding laboratory challenged FDA's decision, arguing that the agency should have gone through formal notice-and-comment rulemaking and that its determination ending the shortage was arbitrary and capricious.

The Fifth Circuit rejected the challenge. The three-judge [panel ruled](https://www.ca5.uscourts.gov/opinions/unpub/25/25-10600.0.pdf?ref=fdaweb.com) that, even assuming FDA should have used notice-and-comment procedures, the compounders failed to demonstrate that the alleged procedural error prejudiced them. The court also concluded that the agency’s shortage determination was not arbitrary or capricious.

The court noted that FDA initially removed tirzepatide from the shortage list 10/2024\. After the compounders sued, the agency reconsidered the decision and reaffirmed in 12/2024 that the shortage had been resolved.