Texas court refuses to freeze FDA finding that ended semaglutide shortage
A Texas court let the FDA's finding that Ozempic and Wegovy are no longer scarce stand, shutting the main legal route compounding pharmacies used to make copies [1].
A federal judge in Texas refused on April 24 to freeze the FDA's determination that injectable semaglutide is no longer in short supply, allowing the agency's finding to remain in force and closing off the main legal path compounding pharmacies used to make copies of Ozempic and Wegovy [1].
The request came from a trade group representing compounders, which asked the court to set the FDA action aside while the case moved forward. The judge ruled for the FDA and for Novo Nordisk, which makes both brand-name drugs, according to a company statement issued April 25 [1].
At the center of the dispute is the FDA's earlier conclusion that every dose of Wegovy and Ozempic is fully available across the country, and that Novo Nordisk's output is meeting or exceeding current and projected nationwide patient demand [1]. Under federal compounding law, pharmacies may generally prepare copies of a commercially available drug only while that drug is listed as scarce. Novo Nordisk says the shortage's end means making or selling imitation "semaglutide" is now unlawful in the US, apart from limited exceptions [1].
Enforcement timing differs by pharmacy type. The FDA may move right away against 503A pharmacies, which mix medicines for individual patients [1]. For 503B outsourcing facilities, which produce in bulk, a window that allowed compounding runs out on May 22, 2025, after which the agency may act [1].
A second ruling in the Southern District of Texas ended a case against MediOak Pharmacy LLC, a 503A pharmacy. A judge entered a final judgment and a permanent injunction that prevents the business from marketing or selling compounded "semaglutide" [1].
"We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy and Ozempic is resolved," said Steve Benz, corporate vice president for legal and US general counsel at Novo Nordisk [1]. He added that the company will keep pressing its lawsuits and "escalate our efforts as necessary" [1].
That docket is large: 111 suits in federal courts across 32 states against sellers of compounded "semaglutide," according to the company, which says some products carried impurity levels as high as 33 percent or listed strengths that did not match their labels [1]. A Delaware court entered an $8.5 million default judgment in a case involving claims that a compounded product was equivalent to Ozempic [1]. In Tennessee, a pharmacy named Midtown Express was permanently barred after Novo Nordisk said the drug it sold contained no semaglutide at all [1].
Novo Nordisk also pointed to a Brookings Institution report, "The Wild East of semaglutide," which found that three Chinese manufacturers accounted for 20 percent of the semaglutide reported as imported into the US between March 2023 and September 2024 and had not been inspected by the FDA as of September 2024 [1]. Three different Chinese firms, linked to nearly 45 percent of reported import volume during those 18 months, drew citations for good-manufacturing-practice violations at their most recent FDA inspection [1]. The company says it does not provide the semaglutide ingredient used in its approved products to anyone for compounding [1].
State and federal officials have raised separate alarms. A bipartisan group of 38 state attorneys general urged the FDA to act against compounders [1]. Ohio's attorney general sent warnings to 14 entities, and Illinois' attorney general issued cease-and-desist letters to five Chicago-area med spas in December 2024 [1]. The FBI cautioned that some providers use "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
For people who have been getting semaglutide from a compounding pharmacy, the supply route is narrowing. The court did not direct any specific pharmacy to stop selling, so what happens at individual counters will depend on choices by pharmacies, prescribers and state regulators that have not been detailed publicly [1]. Wegovy and Ozempic remain on the market as FDA-approved products, and the manufacturer says its supply is keeping pace with demand [1].
How many patients rely on compounded semaglutide has not been disclosed. Nor has it been reported how much of the compounded drug is still being dispensed, whether the trade group will appeal, or when the FDA might bring a first enforcement action [1].
What happens next
May 22, 2025 is the date the 503B outsourcing-facility window closes [1]. For 503A pharmacies, the FDA can act at any time now that the shortage finding survives [1]. Novo Nordisk says it intends to keep filing and pursuing lawsuits [1].
Sources
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