Outsourcing Facilities Association sues FDA over the semaglutide delisting

The Outsourcing Facilities Association (OFA) and a Texas compounder sued the U.S. Food and Drug Administration on February 24, 2025, asking a federal judge to overturn FDA's February 21 declaration that the shortage of injectable semaglutide is resolved ^[1]. The case, No. 4:25-cv-00174-P, was filed in the Northern District of Texas, Fort Worth Division, against FDA and Sara Brenner in her official capacity as Acting Commissioner of Food and Drugs ^[1].

The second plaintiff is North American Custom Laboratories, LLC, doing business as FarmaKeio Superior Custom Compounding ^[1]. OFA is a trade association based in Fort Worth that represents outsourcing facilities, including facilities that compound semaglutide ^[1]. The complaint says all OFA members "will be prohibited from compounding semaglutide" by the FDA action being challenged ^[1].

What the lawsuit argues

The complaint calls FDA's move "a reckless and arbitrary decision" that deprives patients of treatment for type 2 diabetes, obesity and cardiovascular disease, and says the agency "abruptly" changed the rules "with a post to its website" ^[1]. The plaintiffs argue that removing a drug from the shortage list is a substantive rule under the Administrative Procedure Act, which they say required FDA to publish a proposal in the Federal Register, take public comments and explain its reasoning — steps the suit says FDA skipped entirely ^[1].

The filing also points to the manufacturer's own securities disclosure. It says the maker of FDA-approved semaglutide stated in a Form 20-F filed February 5, 2025 — about two weeks before FDA's action — that "supply constraints" and "drug shortage notifications" will continue into the foreseeable future ^[1]. The complaint says FDA itself acknowledged that "many" patients cannot access semaglutide products ^[1].

The legal stakes turn on two provisions. Under Section 503B, compounding from bulk active ingredients is generally not allowed unless the drug is on FDA's shortage list at the time of compounding, distribution and dispensing ^[1]. Separately, the law bars compounding a drug that is "essentially a copy" of an approved drug, but exempts drugs on the shortage list ^[1]. As the complaint puts it, listing "marks the difference between a lawful business enterprise and a federal-law violation" ^[1].

FDA's side and the deadlines

FDA added Wegovy to the shortage list in March 2022 and Ozempic in August 2022 ^[2]. In deciding the shortage was resolved, FDA said it confirmed the manufacturer can meet present and projected U.S. demand, weighing production capability, existing inventory and wholesaler inventory, and said it also considered input from "telehealth companies, pharmacy compounders, associations representing pharmacy compounders and outsourcing facilities, and individuals" ^[2].

To limit disruption, FDA set enforcement discretion periods: 503A state-licensed pharmacies and physicians may compound, distribute or dispense semaglutide injection products that are essentially copies until April 22, 2025, and 503B outsourcing facilities until May 22, 2025 ^[2]. Those windows are longer than FDA's usual 60 days for 503B facilities after a delisting and mirror what FDA did when it resolved the tirzepatide shortage ^[2].

Why it matters for patients

If the dates hold, people who have been getting compounded semaglutide injections face a hard stop. Law firm analysts note that providers should not be ordering, prescribing or dispensing those products after April 22, 2025, if they come from a 503A pharmacy, or after May 22, 2025, if they come from a 503B facility ^[2].

FDA's order does not shut off every compounded option. It does not restrict 503A or 503B compounders from making semaglutide injection products that are not essentially copies and are compounded to meet individual patient needs, such as a different dose or different inactive ingredients ^[2]. FDA also acknowledged in its order that patients using compounded products may face gaps in treatment and that local shortages could persist ^[2].

One practical wrinkle: moving to brand-name semaglutide can run into insurance hurdles, including prior authorization, and a large number of patients are expected to shift at once ^[2].

What happens next

• April 22, 2025 — end of FDA's enforcement discretion for 503A pharmacy compounding of essentially-copy semaglutide injections ^[2].
• May 22, 2025 — end of the window for 503B outsourcing facilities ^[2].

Whether the court will pause or reverse FDA's delisting before those dates is not stated in these sources. The complaint asks for "immediate intervention" ^[1], but no ruling appears in the available documents.