Compounded GLP-1s Face a Final Countdown as the Compounding Ban Tightens
- Jennifer Hardy
- 8 hours ago
- 2 min read
The window for GLP-1 compounders to tap dance around the compounding ban is almost closed — and anyone still trying to squeeze through could end up with some bruised fingers.
A federal court ruling has backed the FDA’s determination that shortages of Wegovy and Ozempic are officially over, setting up a sharp end to the era of legally available compounded GLP-1s.
What the Court Ruling Actually Means
On April 24, U.S. District Court Judge Mark Pittman upheld the FDA’s call that Novo Nordisk’s GLP-1 medications are no longer in shortage.
The decision — filed under seal — leaves in place the agency’s timeline that gives compounding pharmacies until May 22, 2025, to shut down production of compounded semaglutide.
After that, the FDA is free to start enforcement actions against any 503B outsourcing facilities that don’t comply. Traditional 503A compounding pharmacies, which operate under state oversight, are expected to stop immediately.
Why the Compounding Ban Is Happening
Under federal law, pharmacies can only produce compounded versions of a drug if the branded product is in FDA-declared shortage.
Since Wegovy and Ozempic supply has stabilized, that exemption no longer applies. Even though the Outsourcing Facilities Association argued that shortages are still happening in practice, the court declined to review additional evidence submitted after the case began.
For now, the FDA’s position stands: no shortage, no compounding.
Where Novo Nordisk and the FDA Stand
Novo Nordisk welcomed the court’s decision, saying it’s based on a growing, stable supply of its FDA-approved medications. The company, along with Eli Lilly (which makes Mounjaro and Zepbound), has poured serious money into expanding manufacturing capacity over the past two years.
Some of those new production sites are still coming online, but both companies say they’ve ramped up enough to meet current demand — leading the FDA to officially resolve shortages for tirzepatide in December 2024 and semaglutide in February 2025.
What Happens Next for Compounded GLP-1s
Unless another legal twist happens (and fast), compounded GLP-1s are heading for the exit.
After May 22, outsourcing facilities still making semaglutide versions could be targeted by the FDA. Patients using compounded options should talk with their healthcare providers now about switching to FDA-approved products.
At the same time, access is getting easier. Lilly expanded its LillyDirect platform last year, offering Zepbound directly to patients. Novo Nordisk followed with NovoCare, a new online pharmacy service for Wegovy users. Both moves make it a little harder for compounders to argue there’s no other way for patients to access treatment.
The Bigger Picture for Patients and Providers
This compounding ban marks a real turning point in the GLP-1 landscape. For a lot of patients, compounded GLP-1s filled critical gaps when brand-name medications were nearly impossible to find.
Now, the ground is shifting again. Even as lawsuits continue, the court's message is clear: it’s time to transition back to the approved versions — or be ready for some fallout.
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