FDA Resolves Semaglutide Shortage: What It Means for Ozempic®, Wegovy®, and Compounded Versions

FDA Declares End to Semaglutide Shortage

On February 21, 2025, the FDA issued a declaratory order announcing that the shortage of semaglutide injection products — namely Ozempic® and Wegovy® — has been resolved. Semaglutide, a GLP-1 receptor agonist used to manage type 2 diabetes, and obesity, had been in short supply since 2022 due to unprecedented patient demand. FDA confirmed that Novo Nordisk’s current production capacity now meets or exceeds both current and projected national demand, although some localized supply disruptions may still occur as products move through the supply chain.

Compounding Pharmacy Exceptions: FDA Regulations, Drug Shortages, and Clinical Necessity

Compounding is the process by which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under a licensed pharmacist’s supervision, combines, mixes, or alters drug ingredients to create a medication tailored to an individual patient’s needs.

While a drug shortage exists, compounding pharmacies may produce copies of an FDA-approved drug even if this product is under market exclusivity.[1] This flexibility ensures continued access for patients when the approved drug supplier cannot meet demand. Because of increased patient demand, the majority of compounded semaglutide fell under this regulatory exemption that permits compounding during an FDA-declared shortage.

Now that the shortage is resolved, the only permitted pharmaceutical compounding for these medications is under the clinical difference exception.[2] This applies when a specified and documented change is necessary for an identified patient whose medical needs cannot be met by the commercially available product. For example, subject to distinct conditions, 503A compounding pharmacies or 503B outsourcing facilities may “customize” prescriptions for patients with allergies or ingredient sensitivities, who may have difficulty swallowing standard tablets or capsules, or need alternatives to commercial dosing.

Compounding is governed by sections 503A and 503B of the Food, Drug and Cosmetics Act (FD&C Act), with 503A applying to licensed pharmacists in state-licensed pharmacies or federal facilities, as well as licensed physicians, while 503B covers FDA-registered outsourcing facilities.

Semaglutide Compounding Deadline: Key Dates and FDA Transition Guidelines

On its website, the FDA has provided a timeframe for state-licensed pharmacies, physicians, and outsourcing facilities to unwind their compounding activities related to semaglutide. Under this transition period:

• State-licensed pharmacies and physicians compounding under section 503A of the FD&C Act may continue compounding, distributing, or dispensing semaglutide injection products that are essentially copies of FDA-approved drugs until April 22, 2025 (60 days from the FDA’s announcement).
• Outsourcing facilities under section 503B of the FD&C Act may continue these activities until May 22, 2025 (90 days from FDA’s announcement).

After these deadlines, compounding semaglutide will only be permitted under clinical difference exceptions. The FDA has also emphasized that it retains enforcement authority during the transition period and may take action against compounded products that fail to meet regulatory or safety standards, particularly if they are found to be of substandard quality or otherwise unsafe.

Lawsuit Challenges FDA’s Removal of Semaglutide from Shortage List: Impact on Compounding and Patient Access

Following the declaratory order, the Outsourcing Facilities Association (OFA), a trade association representing 503B outsourcing facilities, and a Texas-based pharmaceutical compounder sued the FDA. The complaint alleges that the agency unlawfully and arbitrarily removed semaglutide from the drug shortage list without following the required notice-and-comment rulemaking process. The plaintiffs argue that the shortage remains unresolved despite the FDA’s decision and that the removal effectively bans compounding, cutting off patient access to treatment while benefiting brand-name manufacturers.

This is OFA’s second lawsuit against the FDA over its termination of a drug shortage. Last October, the association sued after the agency removed tirzepatide from the shortage list in a case that is still pending in the U.S. District Court for the Northern District of Texas. The outcome of these litigations is significant as up to 2 million Americans currently use compounded formulations of Novo Nordisk’s semaglutides (Wegovy ®  and Ozempic ®) and Eli Lilly’s tirzepatides (Zepbound ® and Mounjaro ®).

Regulations for Drug Compounding: Licensing, FDA Compliance, and Legal Considerations

Compounding is a regulated practice that requires proper licensing. Under federal law, only licensed professionals—such as pharmacists and physicians—are legally allowed to compound. Additionally, outsourcing facilities must be registered with the FDA and operate under the supervision of a licensed pharmacist. If you are a compounding pharmacy or marketer of GLP-1’s or peptides and have questions regarding the status of regulations affecting your company, do not hesitate to reach out to us at Asebey Life Science Law.