Tracker / Compounded GLP-1s
Is compounded semaglutide or tirzepatide still legal?
Short answer · as of Oct 17, 2026
Only in narrow cases. The drug shortages that allowed broad compounding ended in 2024 and 2025. A state-licensed pharmacy can still compound semaglutide or tirzepatide for an individual patient when a prescriber documents a medical need the approved drug can't meet.
Lower cost doesn't count as a medical need under FDA policy. Mass-marketed copies are what the FDA is going after.
Medically reviewed by Hara Rosen Berger, DO — double board-certified endocrinologist and Voluntary Assistant Professor of Clinical Medicine, University of Miami Miller School of Medicine. Review covers this page.
GLP-1 status at a glance
Compounding rules here have moved through the courts and change more often than the peptide list.
| Drug | Approval | Where it stands | Status |
|---|---|---|---|
| Semaglutide Wegovy, Ozempic | FDA-approved | Prescribable today through a licensed provider, with brand-name versions filled at pharmacies. | Approved |
| Tirzepatide Zepbound, Mounjaro | FDA-approved | Prescribable today through a licensed provider, with brand-name versions filled at pharmacies. | Approved |
| Compounded semaglutide and tirzepatide | Not FDA-approved | Limited to a documented patient-specific need. The FDA is enforcing against mass-marketed copies, and has proposed closing the outsourcing-facility route. | Narrow exception |
| Retatrutide investigational | Not approved | Can't be compounded under federal law. Clinical trials are the only legitimate access. | No legal route |
How we got here
The broad compounding era rested on drug shortages. Once those ended, the legal basis narrowed step by step.
- Dec 2024Tirzepatide shortage declared overThe FDA confirms the shortage has ended, which starts the end of broad compounding of tirzepatide copies.
- Feb 2025Semaglutide shortage declared overThe same happens for semaglutide. After wind-down periods in 2025, pharmacies lose the shortage basis for making copies.
- Mar 2026Warning letters to 30 telehealth companiesThe FDA targets how compounded GLP-1s are marketed, including claims that imply they're the same as approved drugs.
- Apr 30, 2026FDA proposes closing the 503B routeThe FDA proposes leaving semaglutide, tirzepatide, and liraglutide off the list outsourcing facilities can compound from, finding no clinical need absent a shortage. Published in the Federal Register May 1.
- Aug 27, 2026Appeals court upholds the shortage decisionsA federal appeals court sides with the FDA on its decisions that the shortages had ended.
- Sep 18, 2026Warning letter to Empower PharmacyOver semaglutide and tirzepatide combined with B12 or niacinamide, which the FDA called essentially copies of approved drugs. A warning letter states the agency's allegations and isn't a final finding.
503A and 503B, in plain English
Compounded drugs come from one of two kinds of facility, and the rules differ.
503A: state-licensed pharmacies
These pharmacies compound for an individual patient's prescription. They generally can't regularly make copies of a commercially available drug, like semaglutide or tirzepatide. The exception is when the prescriber determines that a change makes a significant difference for that patient. That's why a provider's documented clinical reason matters.
503B: outsourcing facilities
These facilities register with the FDA and can make larger batches. They can compound from bulk ingredients only when a drug is on the FDA's shortage list or on the 503B bulks list. Semaglutide and tirzepatide are on neither. The FDA's April 2026 proposal would formally keep them off the bulks list, closing that route if finalized.
Liraglutide is different for now. As of the May 2026 proposal, liraglutide injection was still on the shortage list, so outsourcing facilities could compound it.
What the FDA has flagged about compounded GLP-1s
The FDA's public guidance on unapproved GLP-1s lists several specific concerns:
- Dosing errors. Some adverse event reports, including hospitalizations, may be tied to dosing mistakes with compounded injectable semaglutide. As of May 31, 2026, the FDA had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide.
- Salt forms. Semaglutide sodium and semaglutide acetate aren't the same active ingredient as the approved drug, and the FDA says they shouldn't be used to compound semaglutide.
- Shipping temperature. Injectable GLP-1s need refrigeration, and the FDA has received complaints of compounded products arriving warm.
- Fraudulent products. The FDA advises checking compounded GLP-1 labels for warning signs such as spelling errors.
- Misleading marketing. Compounded drugs aren't generics, and claims like “same ingredients as Ozempic” imply an FDA review that never happened.
If you're on a compounded GLP-1 now
A compounded GLP-1 can still be prescribed legally when a clinician documents a specific medical reason you can't use the approved product. If your provider only offers compounded versions, ask:
- What's the clinical basis for compounding in my case?
- Which pharmacy fills it, and is it licensed in my state?
- Is the active ingredient the same form as the approved drug, not a salt form?
- Is a brand-name option available, and what would it cost me?
Semaglutide and tirzepatide aren't the only approved options. Exenatide (Byetta, Bydureon), liraglutide (Victoza, Saxenda), lixisenatide (available as Soliqua), and dulaglutide (Trulicity) are also FDA-approved GLP-1 receptor agonists, and Eli Lilly now markets an oral GLP-1, Foundayo (orforglipron). Which one fits is a question for your prescriber.
Thinking about an approved option? Here's how to vet a provider →
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