Is Compounded Semaglutide or Tirzepatide Legal in 2026?
Yes, but under much tighter rules than in 2023–2024. The FDA ended the tirzepatide and semaglutide shortages (in late 2024 and February 2025), and a federal appeals court upheld both decisions in August 2026. Pharmacies may no longer routinely make copies of the brand-name drugs, but a state-licensed pharmacy can still compound for an individual patient when their prescriber documents a clinical reason. Compounded versions are not FDA-approved, and regulators are cracking down on misleading marketing.
The timeline
| Date | What happened |
|---|---|
| Oct 2 & Dec 19, 2024 | FDA declares the tirzepatide shortage over, then reconfirms it. source |
| Feb 18 / Mar 19, 2025 | Grace period for compounding tirzepatide copies ends (503A pharmacies / 503B outsourcing facilities). source |
| Feb 21, 2025 | FDA declares the semaglutide shortage over. source |
| Apr 22 / May 22, 2025 | Grace period for compounding semaglutide copies ends (503A / 503B). source |
| Sep 5, 2025 | FDA starts a "green list" so only approved foreign makers can ship GLP-1 ingredients into the U.S. source |
| Sep 9, 2025 | FDA and HHS crack down on misleading drug ads, including warning letters to GLP-1 telehealth companies. source |
| Feb 6, 2026 | FDA says it will restrict GLP-1 ingredients used in mass-marketed compounded drugs. source |
| Mar 3, 2026 | FDA announces warning letters to 30 more telehealth companies over misleading compounded GLP-1 claims. source |
| Apr 30, 2026 | FDA proposes keeping semaglutide, tirzepatide and liraglutide off the list of ingredients outsourcing facilities may compound in bulk. Comments closed July 30, 2026; no final decision yet. source |
| Aug 27, 2026 | The Fifth Circuit Court of Appeals upholds FDA's decisions that both shortages are over. tirzepatide ruling, semaglutide ruling |
What's allowed now
Federal law has two kinds of compounders. 503A pharmacies are state-licensed pharmacies that fill prescriptions for individual patients and are regulated mainly by state pharmacy boards. 503B outsourcing facilities register with the FDA, follow manufacturing (CGMP) standards and can produce in larger volumes. source
- With the shortages over, neither type may routinely make drugs that are essentially copies of the FDA-approved brand-name semaglutide and tirzepatide drugs. source
- A 503A pharmacy can still compound for an individual patient when the prescriber documents a significant clinical difference (for example, a different dose or formulation the patient needs). source
- Compounded drugs are not FDA-approved: the FDA doesn't review them for safety, effectiveness or quality before they reach patients, and they are not generics. source
- Salt forms (semaglutide sodium or acetate) are different ingredients from the approved drugs, and the FDA says it has no safety data on them. source
Safety warnings from the FDA
- As of May 31, 2026, the FDA had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide. source
- Dosing errors with multi-dose vials have led to patients taking 5 to 20 times the intended dose. Confirm exactly how to measure your dose with your provider or pharmacy. source
- The FDA has found fake pharmacy names on some compounded product labels, and has issued multiple counterfeit brand-name semaglutide alerts. source
Lawsuits
- Eli Lilly sued several telehealth sellers of compounded tirzepatide in April 2025, including Mochi Health, Fella Health, Willow and Henry Meds. In April 2026 a judge let Lilly's claims against Mochi proceed. source
- Novo Nordisk said it had filed 111 lawsuits in 32 states over compounded semaglutide by April 2025. It sued Hims & Hers in February 2026, then dropped the case in March 2026 as part of a deal under which Hims offers brand-name semaglutide and stops advertising compounded GLP-1s except where medically necessary. source
States are adding their own rules
Some states go further than federal law. For example, California's pharmacy board requires pharmacists to verify and document a clinically significant difference before compounding a copy, and Ohio's pharmacy board has said GLP-1 copies may not be compounded now that the shortages are over. See your state's page for details: California, Ohio, Connecticut, Washington, New Jersey, Alabama, or all states.
How to check a provider before you pay
- Check the pharmacy's license in your state board of pharmacy database (linked from the FDA's BeSafeRx site). source
- Look for FDA's safe signs: a valid prescription is required, there's a U.S. address and phone number, and a licensed pharmacist is available. source
- Check LegitScript certification with its free public lookup (LegitScript is a private certifier, not a government agency). source
- Red flags: claims of an "FDA-approved pharmacy" (the FDA doesn't approve pharmacies), calling a compounded drug "generic" or "the same as brand-name semaglutide", salt forms, and any "research-grade" peptide sold without a prescription. source
Our provider reviews list each provider's pharmacy disclosures, LegitScript status and any FDA warning letters, with sources.
FAQ
Is compounded tirzepatide legal in 2026?
Yes, in limited circumstances. The shortage ended in late 2024, so routine copies are no longer allowed, but a state-licensed 503A pharmacy can compound for an individual patient when the prescriber documents a significant clinical difference. It is not FDA-approved.
Is compounded semaglutide legal in 2026?
Under the same rules: the shortage ended February 21, 2025, routine copies are barred, and patient-specific compounding with a documented clinical reason is still permitted. It is not FDA-approved.
Did a court overturn the FDA shortage decisions?
No. A Texas federal court declined to block them in 2025, and on August 27, 2026 the Fifth Circuit upheld FDA on both tirzepatide and semaglutide.
Is the FDA banning compounded GLP-1s?
Not outright. In April 2026 the FDA proposed keeping semaglutide, tirzepatide and liraglutide off the bulk list for 503B outsourcing facilities; comments closed July 30, 2026 and no final decision has been issued. The proposal does not end patient-specific 503A compounding.
Is compounded the same as generic?
No. The FDA stresses that compounded drugs are not generics and are not FDA-approved.
Prices change often; always confirm the current price and terms with the provider. Compounded medications are not FDA-approved finished drug products. This page is not medical advice.