Judge denies injunction on compounded semaglutide, letting FDA deadlines stand
A Texas court refused to pause the FDA's wind-down for compounded semaglutide, so small pharmacies must stop now and large facilities by May 22, 2025.
On April 24, 2025, a federal district court in Texas denied a preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.), a case about compounded semaglutide [1]. The ruling leaves the FDA's wind-down deadlines for compounded copies of the drug in place [1].
With that decision, the FDA says its period of enforcement discretion has ended for state-licensed pharmacies and physicians that compound, dispense or distribute semaglutide injection products under section 503A of the Food, Drug, and Cosmetic Act [1]. That discretion was set to run until April 22, 2025, or until the court ruled, whichever came later [1]. For larger outsourcing facilities under section 503B, the FDA does not intend to take action for violations that depend on semaglutide injection products' inclusion on the agency's drug shortage list until May 22, 2025 [1].
The FDA declared the semaglutide injection shortage resolved on February 21, 2025; the products had been in shortage since 2022 because of increased demand [1]. The agency said it confirmed with the manufacturer that stated product availability and manufacturing capacity can meet present and projected national demand [1]. It also said patients and prescribers may still see intermittent, limited local supply disruptions [1].
The Outsourcing Facilities Association, a trade group that represents FDA-sanctioned compounding pharmacies, sued over the shortage decision [2]. The FDA had said it would not take enforcement action against compounders until after the court ruled [2]. By denying the injunction, the FDA's timeline for large compounders remains in place, according to the American Med Spa Association [2]. Smaller compounding pharmacies, which fill prescriptions for individual patients and are mainly overseen by states, must immediately stop making copies of semaglutide [2].
Tirzepatide, the active ingredient in Mounjaro and Zepbound, went through a similar process. On March 5, 2025, a district court denied a preliminary injunction motion in a related case [1]. Enforcement discretion ended for section 503A compounders, and for outsourcing facilities the FDA said it would not take action until March 19, 2025 [1]. The FDA dates its decision finding the tirzepatide shortage resolved to December 19, 2024, after re-evaluating an earlier determination [1], while the American Med Spa Association describes the tirzepatide shortage as having been listed as resolved in August 2024 [2].
Some compounding can continue. Under the FDA's guidance on products that are "essentially a copy" of a commercially available drug, a compounded product that combines semaglutide with another active ingredient such as vitamin B12 may be treated as an essentially-a-copy product when it is given the same way and each ingredient is within 10 percent of the strength of the commercially available products [1]. The FDA has said it does not intend to act against a compounder for making an essentially-a-copy product regularly or in inordinate amounts if it fills four or fewer prescriptions of that product in a calendar month [1]. Separately, outsourcing facilities may not compound with bulk drug substances unless the substance is on the 503B bulks list or the drug is on the shortage list when it is compounded, distributed and dispensed; semaglutide and tirzepatide are on neither list [1].
There is also a patient-specific medical necessity exception. An authorized provider must determine that a patient needs a personalized medication for a specific, medically necessary reason and document it on the prescription and in the patient's medical records [2]. The exception applies only when a patient's needs cannot be met by an available FDA-approved drug, such as an allergy to an ingredient or an inability to swallow pills [2]. Drug cost is not a sufficient reason, and adding a substance such as vitamin B12 would not comply, per FDA guidance [2].
Why it matters for patients
People who have been getting compounded semaglutide from a state-licensed pharmacy face the end of that supply now, while those supplied by larger outsourcing facilities have until May 22, 2025 [1][2]. The FDA has said approved supply can meet national demand, but it also warned of intermittent, limited local disruptions [1]. Cost alone will not qualify someone for the medical necessity exception [2]. A person with a documented medical reason, such as an allergy to an ingredient in the approved formulation, may still be able to get a compounded version if a prescriber documents it [2]. How many patients currently use compounded semaglutide, and how they will be moved to approved products, has not been reported.
What happens next
May 22, 2025 is the date through which the FDA says it does not intend to take action against outsourcing facilities for violations that depend on semaglutide injection products' shortage-list status [1]. After that, the agency says it may still act on other violations, such as findings that a product is substandard or otherwise unsafe [1]. The FDA's update does not say whether the association will appeal the April 24 decision [1].
Sources
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