Fifth Circuit issues its companion semaglutide opinion upholding the FDA delisting

The U.S. Court of Appeals for the Fifth Circuit has affirmed a lower court's judgment for the Food and Drug Administration in the lawsuit challenging the agency's decision to take semaglutide off its drug shortage list. The opinion in Outsourcing Facilities Association v. FDA, No. 25-10758, was filed August 27, 2026 and revised on September 1, 2026 ^[1].

The three-judge panel — Judges Richman, Duncan and Oldham — issued a per curiam opinion that is not designated for publication under Fifth Circuit Rule 47.5, meaning it does not carry the same precedential weight as a published decision ^[1]. The appeal came from the U.S. District Court for the Northern District of Texas, case No. 4:25-CV-174 ^[1].

The plaintiffs were the Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners, doing business as FarmaKeio Superior Custom Compounding. The defendants were the FDA and Acting Commissioner Kyle Diamantas, with Novo Nordisk, Incorporated intervening on the agency's side ^[1].

What the court decided

The panel wrote that the case "presents issues similar to those" in the companion case involving Eli Lilly's tirzepatide drugs Mounjaro and Zepbound, No. 25-10600, decided the same day ^[1]. The court affirmed "for the same reasons," holding that "[a]ny error by the FDA in not proceeding through the APA's notice and comment procedures was harmless, and the FDA's ultimate action was not arbitrary or capricious" ^[1]. According to the court's reasoning, affected parties had actual notice of the FDA's process and repeated opportunities to submit information, and the agency reasonably relied on Novo Nordisk's supply, inventory and demand data ^[1].

The regulatory background

The opinion lays out the statutory machinery behind the fight. Novo Nordisk won FDA approval for Ozempic in December 2017 and for Wegovy in June 2021 ^[1]. Both contain semaglutide, a GLP-1 receptor agonist, and the court noted that they "are the only FDA-approved semaglutide injection products" and that Novo Nordisk "is the only company that offers" them ^[1]. The drugmaker also holds a five-year exclusivity period under 21 U.S.C. § 355(c)(3)(E)(ii), plus an additional three years of more limited exclusivity under a separate provision ^[1].

Federal law generally bars pharmacies and outsourcing facilities from compounding drugs that are "essentially copies" of approved products, but that prohibition is temporarily suspended when a drug appears on the FDA's shortage list ^[1]. The statute defines a drug shortage as the "period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug" ^[1].

The FDA added Wegovy to the shortage list on March 31, 2022 and Ozempic on August 23, 2022, which allowed compounders meeting the statutory conditions to make semaglutide products ^[1]. The agency did not use notice-and-comment rulemaking before adding the drugs to the list ^[1].

Why it matters for patients

The practical effect is that the legal opening that allowed large-scale compounding of semaglutide during the shortage stays closed. The court's ruling leaves the FDA's delisting decision standing, and with it the restriction on compounding copies of Ozempic and Wegovy ^[1].

The opinion also restates a distinction that matters for anyone weighing compounded versions: compounded drugs do not go through the "long, comprehensive, and costly testing process" that FDA-approved drugs undergo, and as the FDA guidance cited by the court puts it, "[c]ompounded drugs are not FDA-approved" ^[1].

The decision is about administrative procedure and the FDA's evidence, not about safety or effectiveness of any particular product. The sources do not address drug prices, insurance coverage, or what compounders or telehealth sellers will do in response.

What happens next

Because the opinion is unpublished, it resolves this appeal but is not binding precedent in future Fifth Circuit cases ^[1]. The tirzepatide companion case, No. 25-10600, was decided August 27, 2026 and is also unpublished ^[1].

It is not yet known from the available sources whether the plaintiffs will seek rehearing, rehearing en banc, or Supreme Court review, and no deadlines for those steps are stated in the opinion ^[1].