Regulation desk · GLP-1 compounding
Compounded semaglutide and tirzepatide after the shortages ended
How the end of the semaglutide and tirzepatide shortages changed compounding: dates, the 'essentially a copy' rule, and where research GLP-1s fit.
The short answer ·
FDA declared the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage resolved on February 21, 2025. After grace periods ending between February and May 2025, pharmacies could no longer rely on shortage status to compound essentially-copies of those drugs.
Compounding is still possible in narrower cases, such as a documented clinical difference for a patient. 'Research' GLP-1s sold online were never covered.
What are the key dates?
| Date | Event |
|---|---|
| Oct 2, 2024 | FDA first decides the tirzepatide shortage is resolved (later re-evaluated) |
| Dec 19, 2024 | FDA issues a new decision: tirzepatide shortage resolved |
| Feb 18, 2025 | End of 503A tirzepatide wind-down (or later court date in OFA v. FDA) |
| Feb 21, 2025 | FDA: semaglutide shortage resolved |
| Mar 19, 2025 | End of 503B tirzepatide wind-down (or later court date) |
| Apr 22, 2025 | End of 503A semaglutide wind-down |
| May 22, 2025 | End of 503B semaglutide wind-down |
| Sep 9, 2025 | FDA warning letters to sellers of compounded GLP-1s, including false or misleading claims |
What legal mechanism allowed shortage compounding?
Both 503A and 503B restrict compounding drugs that are “essentially a copy” of an approved drug. Drugs on FDA’s shortage list are an exception. During the shortages, that exception allowed mass compounding of semaglutide and tirzepatide. When FDA declared each shortage over, it gave compounders a short period during which it would not act on “violations of the FD&C Act arising from conditions that depend on” the shortage listing. After that, shortage-based copies lost their footing.
What compounding is still possible?
Compounding outside the shortage exception is still assessed under the normal 503A and 503B conditions, including the copy limits. FDA’s September 2025 letters also targeted marketing. It said claims implying compounded products were the same as, or FDA-approved like, the brand drugs were false or misleading under sections 502(a) and 502(bb).
Where do “research” GLP-1s fit?
Online sellers of semaglutide, tirzepatide and retatrutide labeled “research use only” are not pharmacies or outsourcing facilities. The shortage exception never applied to them. The warning letters sent to them before and after the shortages use the unapproved-new-drug analysis instead (explainer). Retatrutide is investigational, has no approval of any kind, and could not have been on the shortage list.
In the news
All news
Frequently asked questions
Is compounded semaglutide still legal?
Pharmacies can no longer compound essentially-copies of semaglutide on the basis of a shortage. Compounding that is not essentially a copy, for example with a prescriber-documented clinically significant difference for a patient, is evaluated under 503A or 503B conditions.
Is retatrutide approved?
No. Retatrutide is an investigational drug. FDA warning letters in 2025 and 2026 treat retatrutide sold online as an unapproved new drug.
Sources
3 linked records- [1] FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize U.S. FDA Primary record
- [2] Warning letter 715883: GLP-1 Solution U.S. FDA · Primary record
- [3] Reuters: Wegovy and Ozempic removed from shortage list Reuters ·
This explainer is general information about law and laboratory methods, not legal or medical advice. Amino Wire does not provide dosing information. Spotted an error? See our corrections policy.