Appeals court upholds delisting of Ozempic and Wegovy in compounding case
The ruling keeps the FDA's semaglutide shortage delisting in place, so compounded copies from outsourcing facilities stay off-limits for patients who had been using them.
The Fifth Circuit has upheld the FDA's removal of the semaglutide drugs Ozempic and Wegovy from the national drug shortage list, turning away an appeal from compounding pharmacies and outsourcing facilities that had challenged the action [1].
The ruling in Outsourcing Facilities Association v. FDA, No. 25-10758, was filed September 1, 2026, and revises an opinion first filed August 27, 2026 [1]. Judges Richman, Duncan and Oldham decided the case per curiam, and the opinion is not designated for publication [1]. The plaintiffs are the Outsourcing Facilities Association and North American Custom Laboratories, L.L.C. Partners, doing business as FarmaKeio Superior Custom Compounding. The FDA and acting commissioner Kyle Diamantas were the defendants, with Novo Nordisk, the maker of both drugs, intervening on the agency's side [1]. The appeal came from the Northern District of Texas, case No. 4:25-CV-174 [1].
The panel concluded that the FDA's decision to drop the two products from the shortage list was not arbitrary or capricious, and that any error from skipping the Administrative Procedure Act's notice-and-comment process was harmless [1]. The judges described the dispute as presenting issues similar to a companion appeal over the tirzepatide drugs Mounjaro and Zepbound, No. 25-10600, decided August 27, 2026, and said they affirmed on the same grounds [1]. Neither opinion is published [1].
Background on the shortage list
Semaglutide is a GLP-1 receptor agonist that helps control blood sugar and is used to treat type 2 diabetes and obesity [1]. The FDA cleared Ozempic in December 2017 and Wegovy in June 2021, and the opinion notes that these two injections are the only FDA-approved semaglutide injection products, with Novo Nordisk the only company offering them [1]. The agency put Wegovy on the shortage list on March 31, 2022, and Ozempic on August 23, 2022, without going through notice-and-comment rulemaking [1].
Federal law generally bars compounding drugs that are essentially copies of approved products, but that restriction is suspended while a drug appears on the shortage list [1]. A shortage is defined in the statute as a stretch when US demand or projected demand runs ahead of supply [1]. Novo Nordisk also holds market exclusivity for the drugs, five years under one provision and three more years under another [1].
Why it matters for patients
Compounded drugs are not FDA-approved [1]. The shortage listings the court left undisturbed had determined whether outsourcing facilities and pharmacies could legally prepare copies of semaglutide. With the delisting upheld, that pathway stays closed, so patients who had been filling semaglutide prescriptions with compounded products from outsourcing facilities may find those products unavailable or no longer offered by the pharmacy they used. What to take instead is a decision for a patient and a prescriber.
The opinion does not address prices, insurance coverage or whether any individual compounded product can still be dispensed, and none of that has been reported. Because the ruling is unpublished, it does not bind other courts in the Fifth Circuit [1].
What happens next
It has not been disclosed whether the compounding groups will ask the full Fifth Circuit to rehear the case or seek review from the Supreme Court. The opinion sets no further deadlines [1].
Sources
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