Fifth Circuit upholds FDA's removal of tirzepatide and semaglutide from the shortage list
Two Fifth Circuit opinions uphold FDA's removal of tirzepatide and semaglutide from the shortage list. The compounders' appeal is over, and copies of the approved drugs are back under the statutory ban.
On August 27, 2026 a Fifth Circuit panel affirmed two Northern District of Texas judgments for FDA: No. 25-10600 on Mounjaro and Zepbound (tirzepatide) and No. 25-10758 on Ozempic and Wegovy (semaglutide), the latter revised September 1. The Outsourcing Facilities Association and FarmaKeio brought both appeals.
The court held that any failure to use notice and comment was harmless because the compounders had actual notice and repeated chances to submit data, and that FDA's reliance on manufacturer supply data was not arbitrary or capricious. With both drugs off the shortage list, compounding essentially a copy of them is prohibited outside the narrow patient specific exceptions.
- 503A and 503B facilities still compounding semaglutide or tirzepatide copies.
- Telehealth platforms built on compounded GLP-1 supply, and the pharmacies filling for them.
The opinions are unpublished, so they bind the parties and persuade elsewhere. The shortage list removals they uphold apply nationwide.
| Source published | August 27, 2026 | Both opinions filed. The semaglutide opinion was revised on September 1, 2026. |
|---|---|---|
| Decided | August 27, 2026 |
The pending litigation was the last cover for volume compounding of these drugs, and it is gone. A general offer of compounded semaglutide or tirzepatide on a pharmacy website is now the fact a reviewer, a processor or FDA will act on. The patient specific exception has to be documented, not assumed.
- List every semaglutide and tirzepatide product you offer and the statutory basis for each.
- Take down any public offer of compounded GLP-1 copies that does not rest on a documented patient specific need.
- Ask each telehealth partner in writing how it is changing prescribing and marketing after this decision.
Compounding (503A and 503B). The Compounding domain of the ScriptSafe standard covers 503A and 503B status and whether the substances a pharmacy offers fall within the statutory exceptions. Shortage list status is one of the inputs to that question.
- Outsourcing Facilities Association v. FDA (Eli Lilly, intervenor), No. 25-10600, per curiam opinion PrimaryU.S. Court of Appeals for the Fifth CircuitNo. 25-10600; USDC No. 4:24-CV-953Retrieved Sep 21, 2026
Pages 2 to 5 (background and holding); the opinion closes with an affirmance.
- Outsourcing Facilities Association v. FDA (Novo Nordisk, intervenor), No. 25-10758, per curiam opinion, revised September 1, 2026 PrimaryU.S. Court of Appeals for the Fifth CircuitNo. 25-10758; USDC No. 4:25-CV-174Retrieved Sep 21, 2026
Page 2: affirmed for the same reasons as the tirzepatide appeal; harmless error and not arbitrary or capricious.
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