Fifth Circuit upholds FDA decisions that ended GLP-1 shortages

A federal appeals court has upheld the FDA's decisions that the shortages of semaglutide and tirzepatide injection products are over, narrowing the path for compounding pharmacies that produced copies of Ozempic, Wegovy, Mounjaro and Zepbound while supplies were short ^[1].

The U.S. Court of Appeals for the Fifth Circuit issued two decisions, one involving semaglutide and one involving tirzepatide. The semaglutide case is No. 25-10758 and the tirzepatide case is No. 25-10600. Both decisions are unpublished ^[1].

What the court decided

Compounding interests challenged the FDA under the Administrative Procedure Act. They argued the agency should have used notice-and-comment rulemaking before removing the drugs from the shortage list, that the FDA acted arbitrarily and capriciously in concluding manufacturers could meet demand, and that the agency wrongly favored manufacturer production and inventory information over evidence from compounders, patients, telehealth companies, pharmacies and others ^[1].

The Fifth Circuit rejected those arguments. On the semaglutide case, the court held that any error from skipping notice-and-comment procedures was harmless because affected parties had actual notice and repeated opportunities to submit information to the agency ^[1]. The court also concluded the FDA reasonably relied on manufacturer supply and inventory data and adequately considered contrary evidence in deciding whether the statutory definition of a shortage was still met ^[1].

In the tirzepatide case, the FDA had discounted information collected through a Hims & Hers website because the submissions did not reliably establish when the reported access problem occurred, where the user was located, why the individual could not get the drug, or whether the same person submitted multiple reports. The Fifth Circuit concluded the FDA reasonably found manufacturer data more probative than that evidence ^[1].

For semaglutide, the FDA relied heavily on Novo Nordisk's production, inventory, supply, wholesaler and projected demand information. For tirzepatide, the agency reviewed Eli Lilly's expanded manufacturing capacity plus information from manufacturers, compounders, patients, healthcare professionals, telehealth companies and others. The FDA allowed transition periods before resuming enforcement of restrictions tied to the end of the shortages ^[1].

What this means for compounding

Federal law generally restricts compounding of drugs that are essentially copies of commercially available or approved products. Those restrictions are relaxed while a drug appears on the FDA's shortage list, allowing compounders that meet the applicable statutory requirements to produce compounded versions during a shortage ^[1].

According to a Clark Hill analysis published September 10, 2026, compounding pharmacies can no longer rely on the former semaglutide and tirzepatide shortages to support routine large-scale production of essentially copies of the approved products. Section 503A pharmacies and Section 503B outsourcing facilities remain subject to different statutory requirements, but both face restrictions now that the shortage exception is unavailable, the analysis says. It advises businesses that expanded GLP-1 operations during the shortages to review whether their products, production practices and distribution models satisfy the requirements in force now ^[1].

Why it matters for patients

Patient-specific compounding is still permitted. Under Section 503A, compounding remains allowed for an identified individual patient when the applicable statutory requirements are satisfied, and federal law recognizes circumstances in which a prescriber determines a compounded product produces a significant difference for a particular patient compared with the commercially available product ^[1].

A patient-specific prescription by itself does not resolve whether a compounded product is essentially a copy or whether other statutory conditions are met. According to the analysis, a formulation developed because an individual patient cannot tolerate an ingredient in the approved drug presents a different situation from a program that routinely directs large numbers of patients to substantially the same compounded product. The FDA can examine the formulation, prescribing documentation, medical justification, pharmacy operations, marketing, and relationships among the telehealth company, prescriber and pharmacy when deciding whether a program meets federal compounding requirements ^[1].

Whether individual telehealth companies, pharmacies or weight-loss programs will change, pause or end their compounded GLP-1 offerings in response to these decisions has not been disclosed.

What happens next

Both decisions are unpublished. The Clark Hill analysis states that district courts considering materially similar challenges must apply the same governing standards, which should lead to the same result absent materially different facts, a different administrative record or a different legal theory ^[1]. The analysis also notes continuing FDA scrutiny of compounded GLP-1 products ^[1].

No enforcement deadlines or compliance dates have been set out, and whether compounding interests will seek further review has not been reported.