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RegulationJune 12, 20263 min read

The FDA is moving to permanently shut down compounded versions of Ozempic, Wegovy and Mounjaro

The FDA has proposed formally barring pharmacies from making compounded copies of semaglutide, tirzepatide and liraglutide. It is the end of the cheaper, copied versions that filled the shortage years.

What happened

During the GLP-1 shortages of recent years, US pharmacies were temporarily allowed to make their own "compounded" copies of these drugs, often sold cheaply through telehealth sites, med-spas and wellness clinics.

Now the FDA has proposed closing that door for good. The agency wants to formally exclude semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound) and liraglutide from the list of drugs that compounding pharmacies are allowed to make in bulk. The shortages are over, so the legal basis for compounding is going away.

Why this matters

Compounded versions are not FDA-approved. They are not tested for purity or dose the way the branded drugs are, and reports of dosing errors and contamination have followed them. The proposal is, on balance, a safety move.

But it has a real cost for many women: compounded versions were often far cheaper, and for some they were the only affordable option. If you have been relying on one, the supply you have may not continue.

What it means for you

If you are on a compounded GLP-1, this is the moment to talk to your prescriber, before your refill, not after. Ask about the approved versions, about manufacturer savings programmes, and, in the US, about the new Medicare coverage that begins this summer.

Two practical things help that conversation go well: knowing your current dose and start date, and bringing a clear record of how you have actually responded. Our guide to getting more from a GLP-1 appointment walks through exactly what to bring.

People also ask
Is the FDA banning compounded Ozempic and Mounjaro?
It has proposed closing the door for good. The agency wants to formally exclude semaglutide, tirzepatide and liraglutide from the list of drugs that compounding pharmacies are allowed to make in bulk. During the shortages, US pharmacies were temporarily allowed to make compounded copies, often sold cheaply through telehealth sites, med spas and wellness clinics. The shortages are over, so the legal basis for compounding is going away.
What does the compounding crackdown mean if I buy a compounded GLP-1?
If you have been getting a compounded version from a telehealth service or a spa, this affects you directly and your supply is likely to change. It is worth understanding what is changing, and talking to a prescriber about the licensed product, before the supply stops rather than after.
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