Texas federal court leaves the FDA shortage decision in place, ending mass compounding of semaglutide

A federal court in Texas on April 24, 2025 denied a compounding trade association's request to freeze the FDA's determination that the shortage of semaglutide injections is resolved, according to an announcement from Novo Nordisk ^[1]. The ruling leaves in place the FDA's finding that all doses of Wegovy and Ozempic are available nationwide, and it removes the main legal justification that allowed pharmacies to mass-produce compounded copies ^[1].

Under US compounding law, pharmacies and outsourcing facilities were permitted to make copies of semaglutide largely because the drug was listed as being in shortage. With that shortage declared over and the court declining to block the decision, Novo Nordisk says it is now illegal to make or sell knockoff "semaglutide drugs," with rare exceptions ^[1]. The company's statement does not spell out what those exceptions are.

The enforcement timeline

Two different deadlines apply. The FDA may immediately take action against 503A compounding pharmacies making copies of Novo Nordisk's approved semaglutide medicines ^[1]. For 503B outsourcing facilities, which operate at larger scale, the grace period expires on May 22, 2025, after which the FDA may take enforcement action ^[1].

The same week, a judge in the Southern District of Texas entered a final judgment and permanent injunction against MediOak Pharmacy LLC, a 503A pharmacy, permanently barring it from marketing or selling compounded "semaglutide" ^[1].

Those cases are part of a much larger campaign. Novo Nordisk says it has filed 111 lawsuits in federal courts across 32 states against entities selling compounded semaglutide, including products it describes as containing impurities as high as 33% or carrying inaccurately labeled strengths ^[1]. A Delaware federal court entered an $8.5 million default judgment against a business that claimed its compounded product was equivalent to Ozempic ^[1]. A Tennessee pharmacy, Midtown Express, was permanently barred after Novo Nordisk sued over a product it says contained no semaglutide at all ^[1]. Another default judgment ended an online marketer's practice of selling compounded semaglutide directly to consumers without a prescription, labeled "Research Use Only" ^[1].

Many of the court orders also require sellers to post disclosures making clear that compounded drugs have not been reviewed or approved by the FDA ^[1].

Questions about the raw ingredient

Novo Nordisk pointed to a Brookings Institution report, "The Wild East of semaglutide," which found that manufacturers of chemically synthesized semaglutide active pharmaceutical ingredient (API) have no external reference standard for quality and set their own specifications ^[1]. According to the report, three Chinese firms accounted for 20% of the reported quantity of semaglutide imported into the US between March 2023 and September 2024 and had never been inspected by the FDA as of September 2024 ^[1]. Three other Chinese firms responsible for nearly 45% of reported import volume over that 18-month period were cited for current good manufacturing practice violations at their most recent FDA inspection ^[1]. Novo Nordisk says it does not distribute the API used in its approved medicines to anyone for compounding ^[1].

Regulators and law enforcement have also weighed in. A bipartisan group of 38 state attorneys general urged the FDA to act against compounders ^[1]. The Ohio Attorney General sent warning letters to 14 entities, and the Illinois Attorney General sent cease-and-desist letters to five Chicago-area med spas in December 2024 ^[1]. The FBI warned that some providers are using "compounded mixtures of unknown drugs that do not contain semaglutide, drugs with high levels of impurities, and unsafe or unapproved drugs" ^[1].

Why it matters for patients

Many people started on compounded semaglutide because it was cheaper or easier to get during the shortage. This ruling means that supply channel is closing. Telehealth platforms, med spas and pharmacies that have been shipping compounded semaglutide face immediate exposure if they are 503A pharmacies, and 503B facilities face the same after May 22, 2025 ^[1].

It is worth noting that the only account of this ruling available here is Novo Nordisk's own press release, which reflects the company's framing. The compounding association's response, the exact scope of the "rare exceptions," and what happens to patients mid-course on compounded product are not addressed in that statement and are not yet known from this source.

What happens next

May 22, 2025 is the date 503B outsourcing facilities lose their grace period ^[1]. Novo Nordisk says it will continue and "escalate" legal actions while working with regulators and law enforcement ^[1].