Compounding trade group sues FDA over semaglutide shortage list removal
The lawsuit challenges the FDA's decision that the semaglutide shortage is over, a finding that ends most compounded versions of the drug by late May 2025.
A trade group representing drug compounders and a Texas compounding pharmacy sued the FDA on February 24, 2025, over the agency's decision to remove semaglutide injection products from the national drug shortage list. The complaint, filed in the U.S. District Court for the Northern District of Texas, Fort Worth Division, calls the decision "reckless and arbitrary" and asks the court to intervene [1].
The FDA had delisted semaglutide injection products three days earlier, on February 21, 2025 [1][2]. Semaglutide is the active ingredient in the FDA-approved injections Ozempic and Wegovy [1]. The agency said it determined the manufacturer can meet both current and projected U.S. demand, and that it weighed the manufacturer's production capacity, existing inventory, wholesaler inventory, and information from telehealth companies, pharmacy compounders, trade associations and individuals [2]. Wegovy was added to the shortage list in March 2022 and Ozempic in August 2022, according to an Alston & Bird advisory [2].
The case is No. 4:25-cv-00174. The plaintiffs are the Outsourcing Facilities Association, a Fort Worth-based trade group whose members compound drugs including semaglutide, and North American Custom Laboratories, LLC, which does business as FarmaKeio Superior Custom Compounding. The defendants are the FDA and Sara Brenner, in her official capacity as Acting Commissioner of Food and Drugs [1].
The complaint argues that removing a drug from the shortage list is a substantive rule, which under the Administrative Procedure Act requires notice-and-comment rulemaking. It says the FDA skipped that process [1]. It also points to a February 5, 2025, SEC filing by the manufacturer of the FDA-approved semaglutide products, which the complaint says warned that "supply constraints" and "drug shortage notifications" will continue into the foreseeable future [1]. The complaint states that the FDA itself confirmed a shortage persists and that "many" patients cannot access semaglutide products [1]. The FDA's public position is that the shortage is resolved [2].
Why the shortage list decides who can compound
Under Section 503B of the federal Food, Drug, and Cosmetic Act, outsourcing facilities generally may not compound from bulk drug substances unless the drug appears on the shortage list, or unless it appears on a separate list of ingredients for which there is a clinical need — a standard the complaint says the FDA has construed so narrowly that an approved drug not in shortage will "virtually never" qualify [1].
The shortage listing carries a second effect. Compounding a drug that is "essentially a copy" of an approved product is barred, but the definition exempts drugs that appear on the shortage list at the time of compounding, distribution and dispensing [1]. Once semaglutide came off that list, compounded copies became unlawful for most facilities [1][2].
Why it matters for patients
The FDA is allowing a transition window rather than an immediate stop. State-licensed pharmacies and physicians compounding under Section 503A may compound, distribute or dispense compounded semaglutide injection products that are essentially a copy of an approved product until April 22, 2025. Outsourcing facilities under Section 503B have until May 22, 2025 [2].
The FDA has acknowledged that patients using compounded products may face gaps in treatment and that local shortages could persist [2]. Compounded products have not gone through FDA premarket review for safety, effectiveness or quality, and they differ from approved products in that respect [2]. Patients moving to an approved product may encounter insurance requirements such as prior authorizations, which the advisory lists as an expected barrier during the transition [2].
The FDA's order does not restrict compounding of semaglutide products that are not essentially a copy of an approved drug — for example, a different dose or different inactive ingredients made to meet an individual patient's needs [2].
What happens next
The lawsuit asks the court for immediate intervention, but the complaint does not set a hearing date, and no ruling has been reported [1]. The April 22 and May 22, 2025, enforcement discretion deadlines remain the dates in effect unless a court changes them [2]. State-licensed pharmacies compound under Section 503A; outsourcing facilities compound under Section 503B [2].
Sources
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