In an August 2026 court opinion, the U.S. Court of Appeals for the Fifth Circuit concluded that any error in the FDA’s decision not to use notice-and-comment procedures was harmless and upheld the agency’s semaglutide shortage determination after a Texas lawsuit brought by compounders.
Fifth Circuit Reviews Challenge to the FDA’s Semaglutide Shortage Determination
On August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit affirmed the district court’s judgment for the FDA and Novo Nordisk in Outsourcing Facilities Association v. FDA, a federal challenge to the agency’s decision that the shortage of Ozempic and Wegovy had resolved. The ruling leaves the FDA’s semaglutide shortage determination in place, with operational relevance for compounding pharmacies, outsourcing facilities, weight-loss clinics, and Med Spas monitoring access to and sourcing of GLP-1 medications.
Fifth Circuit Findings on the FDA’s Semaglutide Delisting Decision
The FDA issued its Declaratory Order on February 21, 2025, determining that the Ozempic and Wegovy shortage had resolved. The Outsourcing Facilities Association and North American Custom Laboratories, doing business as FarmaKeio Superior Custom Compounding, challenged that decision in the U.S. District Court for the Northern District of Texas. The plaintiffs challenged the FDA’s use of notice-and-comment procedures and the evidence supporting the shortage decision. Novo Nordisk intervened as a defendant.
The case then moved through the federal courts:
- April 24, 2025: The district court denied the compounders’ request for a preliminary injunction.
- June 13, 2025: The district court entered summary judgment in favor of the FDA and Novo Nordisk.
- August 27, 2026: The Fifth Circuit issued its opinion affirming the district court’s judgment.
The Fifth Circuit also reviewed the FDA’s shortage analysis:
- Notice-and-comment process: The court found that the lack of a formal public request for comments did not prejudice the compounders because they had notice of the FDA’s continued monitoring of the semaglutide shortage and multiple opportunities to submit information. Over more than three months, the compounders sent the FDA at least 34 separate written submissions.
- Supply and demand review: The court noted that the FDA considered data from September 2024 through February 2025, along with projected demand data for February and March 2025.
- Evidence reviewed: The FDA considered information from Novo Nordisk, the manufacturer of Ozempic and Wegovy, including supply, inventory, wholesaler, and demand data. The agency also reviewed other evidence, including pharmacy availability reports and submissions from compounders, telehealth companies, industry associations, and individuals.
The Fifth Circuit found that the FDA had adequately explained how it evaluated the available information. As of this reporting, semaglutide does not appear on the FDA’s drug shortage list, and the agency’s determination remains in place.
Source Attribution
According to the August 27, 2026 opinion in Outsourcing Facilities Association v. FDA, the U.S. Court of Appeals for the Fifth Circuit affirmed the district court’s judgment in favor of the FDA and Novo Nordisk. The opinion, revised September 1, 2026, details the compounders’ challenge, the FDA’s February 2025 shortage determination, and the evidence the agency considered during its review.
FDA GLP-1 Shortage Decisions and Weight-Management Industry Compliance Context
The Fifth Circuit opinion details how the FDA evaluated whether the national shortage had resolved. Under federal law, a drug shortage exists when demand or projected demand for a drug in the United States exceeds supply.
The opinion outlines areas considered during the FDA’s review:
- Supply data: Manufacturer supply, inventory, wholesaler inventory, and demand information.
- Access reports: Pharmacy availability reports and submissions from compounders, telehealth companies, associations, and individuals.
- Compounded-product volume: The FDA considered 310,000 packages per month produced by outsourcing facilities and another 170,000 packages reported for pharmacy and physician compounders.
- Novo Nordisk supply: The company reported capacity to supply 5.8 million packages of its semaglutide injection products per month, plus finished and semi-finished inventory.
Separately, Novo Nordisk has also been involved in separate 2026 litigation involving semaglutide-based medications. Its lawsuit against Hims & Hers was voluntarily dismissed in March 2026, alongside an agreement for the telehealth platform to offer FDA-approved Wegovy and Ozempic.
At the federal level, shortage status affects when restrictions on compounding products that are essentially copies of approved or commercially available drugs apply under Sections 503A and 503B. Federal GLP-1 activity has continued beyond the shortage decision, including revised FDA product-specific guidances for semaglutide, tirzepatide, and liraglutide issued in July 2026 for generic drug development.
Federal shortage and compounding requirements operate alongside separate state requirements governing prescribing, dispensing, professional licensure, and scope of practice. For Med Spas and weight-management clinics offering GLP-1 services, these federal shortage and compounding rules are relevant when evaluating medication sourcing, while applicable state practice requirements remain separate from the FDA’s national shortage determination.
Under federal law, a drug shortage exists when demand or projected demand for a drug in the United States exceeds supply.
Practical Implications for Med Spas and Weight-Management Clinics
- Review current FDA shortage information when assessing GLP-1 medication access and sourcing options.
- Maintain clear sourcing records for medications used in weight-management services.
- Follow state requirements for prescribing, dispensing, licensure, and scope of practice.
- Differentiate FDA-approved GLP-1 medications from compounded GLP-1 products and other non-FDA-approved products.
- Monitor FDA updates and federal court decisions affecting semaglutide availability and compounding.
What to Watch Next
As of this reporting, the FDA’s determination that the semaglutide injection shortage has resolved remains in place. Future FDA shortage updates, compounding guidance, or additional court filings in the litigation may provide further information affecting semaglutide availability and the federal requirements tied to shortage status.
About Spakinect
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Image Attribution: “Eldon B. Mahon United States Courthouse in Fort Worth, Texas” by Renelibrary, via Wikimedia Commons, licensed under CC BY-SA 4.0.
