Is Compounded Tirzepatide Still Legal in 2026?

Yes, in narrower cases than during the shortage. As of October 22, 2026, a state-licensed pharmacy may compound tirzepatide or semaglutide for one patient when the prescriber determines, and documents, that a change made for that patient produces a significant difference from the approved drug. Both shortages have ended, and the temporary compounding grace periods ended in 2025. Compounded medications are not FDA-approved.

What changed since 2024

The shortage is what let compounded GLP-1s spread in 2023 and 2024. Both shortages have ended, and the courts have upheld those decisions.

1. Oct 2, 2024FDA declares the tirzepatide shortage resolved. On Oct 22, FDA announces that it is reevaluating the decision following a court remand.
2. Dec 19, 2024FDA confirms it: the tirzepatide shortage is resolved.
3. Feb 21, 2025FDA declares the semaglutide shortage resolved.
4. Mar 5, 2025A court declines to block the tirzepatide decision, ending the grace period for 503A pharmacies. For 503B facilities it ends Mar 19.
5. Apr 24, 2025The same for semaglutide: the 503A grace period ends. For 503B facilities it ends May 22.
6. Apr 1, 2026FDA restates the rules for 503A pharmacies and 503B outsourcing facilities.
7. Apr 30, 2026FDA proposes keeping tirzepatide, semaglutide and liraglutide off the 503B bulks list. Comments close Jul 30.
8. Aug 27, 2026The Fifth Circuit upholds both shortage decisions.

What is allowed now

• 503A pharmacies are state-licensed and compound for one named patient. They may compound tirzepatide or semaglutide when the prescriber determines, and documents, that a change made for that patient, such as a dose the brand doesn’t come in, makes a significant difference for them. That is one condition, not the whole law. The other 503A conditions still apply, including a valid prescription for an identified patient and ingredients that meet the law’s requirements. This page cannot tell you whether your own prescription qualifies. That is a question for the prescriber who wrote it.
• 503B outsourcing facilities may not compound from bulk tirzepatide or semaglutide, and a prescription doesn’t change that.
• Not a ban. The April 2026 proposal covers 503B bulk compounding only, and no final decision had been published as of October 22, 2026.
• What “not FDA-approved” means for you. The FDA does not review a compounded medication’s safety, effectiveness or quality before you receive it, and it is not a generic of Zepbound or Wegovy. The FDA has also warned about salt forms of semaglutide, which have no lawful basis in compounding, and about dosing mistakes when measuring from a vial. As of May 31, 2026, the FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide. The FDA notes that many match those seen with the approved drugs, that a report does not show the drug caused the event, and that the numbers are likely undercounts.

How to check a provider

1. A prescription for you by name, after an evaluation. A site that sells it without one is not a lawful source.
2. A reason for compounding that is about you, documented by your prescriber.
3. A state-licensed 503A pharmacy. Ask for the pharmacy’s name and check its license in your state.
4. The prescriber’s license in your state, in the state medical board’s lookup. A national provider identifier is not a license.
5. LegitScript certification, if the provider claims it, in LegitScript’s certification checker.

Board of pharmacy lookups: Alabama · Arizona · Arkansas · Colorado · Connecticut · Delaware · Washington, DC · Florida · Georgia · Hawaii · Idaho · Illinois · Indiana · Iowa · Kansas · Kentucky · Louisiana · Maine · Maryland · Michigan · Minnesota · Mississippi · Missouri · Montana · Nebraska · Nevada · New Hampshire · New Jersey · North Carolina · North Dakota · Ohio · Oklahoma · Pennsylvania · South Dakota · Tennessee · Utah · Vermont · Washington · West Virginia · Wisconsin · Wyoming.

How Gentle Health prescribes compounded medication

Every prescription is written by James Simmons, MD, after he reviews the intake himself. Every compounded prescription is compounded for that patient by a state-licensed 503A pharmacy.

• Why Dr. Simmons often prescribes compounded. He sees many side effects at the brands’ starting doses and prefers to titrate more gradually, in smaller steps than the brands’ fixed strengths allow. A compounded vial makes that possible for patients comfortable drawing their own dose. If you’d rather use a prefilled pen, he also prescribes brand-name Zepbound, Wegovy and Foundayo for $28/month of care.
• A written reason on every compounded prescription, entered by Dr. Simmons for that patient; our system will not save one without it. For most patients the reason is the starting dose and the smaller titration steps chosen for them. Ask us and we will share the reason on your prescription.

Our pharmacies. Compounded injections are filled by AllMedRx Specialty Pharmacy, Premium Compounding Pharmacy and Absolute Pharmacy, each a state-licensed 503A pharmacy. Which one fills yours depends on your state and the preparation Dr. Simmons prescribes; ask us and we will tell you, with its license number in your state. Dr. Simmons’s own license is verifiable in every state we serve through our states page.

Frequently asked questions

Is compounded tirzepatide legal in 2026? Yes, in narrower cases than in 2024. A state-licensed pharmacy may compound it for one patient whose prescriber documents a significant difference, such as a dose Zepbound does not come in. It is not FDA-approved.

Is compounded semaglutide still allowed after the shortage? Yes, on the same terms. The semaglutide shortage ended on February 21, 2025, and the 503A grace period on April 24, 2025.

Can I still get compounded tirzepatide online? Yes, with a prescription from a clinician licensed in your state after an evaluation, filled by a pharmacy licensed in your state.

What does 503A mean? It is the section of federal law for state-licensed pharmacies that compound for an identified patient on a valid prescription. Section 503B covers FDA-registered outsourcing facilities, which may not compound tirzepatide or semaglutide from bulk.

Did the FDA ban compounded GLP-1s? No. Its April 2026 proposal covers 503B bulk compounding only and was not final as of October 22, 2026.

Sources

• FDA, “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize”, updated April 1, 2026
• FDA, “FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List”, April 30, 2026
• Federal Register, document 2026-08552 (May 1, 2026) and its comment extension, document 2026-12937 (June 26, 2026), docket FDA-2018-N-3240
• Fifth Circuit, Outsourcing Facilities Association v. FDA, No. 25-10600 (tirzepatide) and No. 25-10758 (semaglutide), August 27, 2026
• FDA, “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss”, updated October 1, 2026
• FDA guidance on essentially-copies under Section 503A; Section 503A of the FD&C Act, 21 U.S.C. 353a

Dr. James Simmons, MD