The U.S. Court of Appeals for the Fifth Circuit has affirmed a lower court's ruling in favor of the FDA and Novo Nordisk in a closely watched case over compounded semaglutide, rejecting a challenge brought by the Outsourcing Facilities Association and a North Carolina compounder, North American Custom Laboratories (operating as FarmaKeio Superior Custom Compounding). The decision, issued August 27, 2026 and revised September 1, 2026, upholds the FDA's February 2025 determination that the national semaglutide shortage had ended, the finding that triggered federal restrictions on compounding pharmacies making copies of the FDA-approved drug.
What the Case Was About
Under the Federal Food, Drug, and Cosmetic Act, compounding pharmacies (both 503A compounding pharmacies and 503B outsourcing facilities, a distinction covered in more detail elsewhere on this site) are generally barred from making essentially-copies of an FDA-approved drug, with an exception when that drug is officially listed as being in shortage. When the FDA removed semaglutide from its drug shortage list in February 2025, it cut off that exception, and the outsourcing-facility trade group sued, arguing the FDA's process for making that determination was procedurally flawed because it skipped formal notice-and-comment rulemaking.
How the Court Ruled
The Fifth Circuit found that even if the FDA's process had some procedural defect, it was harmless, because the compounding industry had, in practice, already received notice and an opportunity to weigh in: the court pointed to more than 34 written submissions compounders and others made to the FDA over roughly three months before the shortage determination was finalized. The panel also found the FDA had adequately reviewed supply and demand data, including pharmacy-level reporting and compounded-product volume, when it concluded manufacturer supply of semaglutide had caught up with demand.
What Changes in Practice
This ruling doesn't change the underlying rule, which has already been in effect since the FDA's 2025 shortage determination; it removes one of the last open legal challenges to that determination's validity. With semaglutide confirmed off the shortage list and that determination now upheld on appeal, the standard restrictions on 503A and 503B compounding of essentially-copies of an approved drug apply without the shortage exception. Practically, that means pharmacies can still compound semaglutide for a specific patient with a documented clinical need the approved product can't meet, such as an allergy to a specific inactive ingredient, but not simply because a patient wants a cheaper or more available alternative to Ozempic or Wegovy.
How This Fits the Broader Compounding Landscape
Tirzepatide and liraglutide have moved through similar shortage-based restriction timelines, discussed elsewhere on this site, and the FDA has separately proposed a permanent ban on compounding all three GLP-1 active ingredients regardless of shortage status, a proposal that remains open as of this writing. This ruling is specific to semaglutide's shortage-list removal and the process the FDA used to reach it; it doesn't resolve that separate, broader proposed rule, which would need its own notice-and-comment process and could itself face legal challenges if finalized.
What This Means for Patients
Anyone currently using compounded semaglutide should understand that its legal availability is narrower than it was during the official shortage period, and should talk to their prescriber about whether a specific, documented clinical justification applies to their situation, or whether the FDA-approved product is now the only lawful option for their case. This is a regulatory and legal development, not new clinical safety data about semaglutide itself.