Almost every argument about whether a compounded GLP-1 is lawful comes down to a date. Here they are, in order, each with the FDA document it comes from. Where FDA's own pages give a date, we use that; where the only source is a news report or a trade association, we leave it out.
March 2022
Wegovy (semaglutide) added to FDA's drug shortage list
FDA's GLP-1 policy page gives March 2022 for Wegovy and August 2022 for Ozempic. While a drug is listed, a compounded version is not treated as essentially a copy of a commercially available product.
August 2022
Ozempic (semaglutide) added to the shortage list
Both semaglutide injection products were now listed. 503B facilities could compound semaglutide from bulk because the finished drug was on the list.
December 15, 2022
Tirzepatide injection added to the shortage list
Date stated in FDA's December 19, 2024 declaratory order. Mounjaro was the only tirzepatide product at the time; Zepbound was approved in November 2023.
October 2, 2024
FDA declares the tirzepatide shortage resolved
Tirzepatide injection products removed from the list. The order later noted that FDA had received reports that some patients and pharmacists still could not obtain the approved drugs.
October 7, 2024
Outsourcing Facilities Association sues FDA
Outsourcing Facilities Association v. FDA, No. 4:24-cv-953 (N.D. Tex.), as cited in the December 19, 2024 order. FDA moved for a voluntary remand.
October 11, 2024
Court remands the tirzepatide decision to FDA
FDA re-evaluated. In an October 17, 2024 letter to the Alliance for Pharmacy Compounding FDA said it would not act against compounders in the meantime.
December 19, 2024
Declaratory order: tirzepatide shortage resolved (again)
The order revokes and replaces the October 2 decision, finds Lilly's supply meets or exceeds demand, and gives 503A compounders 60 days (to February 18, 2025) and 503B facilities 90 days (to March 19, 2025) before FDA intends to act on shortage-dependent conditions.
February 18, 2025
503A enforcement discretion for tirzepatide ends
February 21, 2025
FDA declares the semaglutide shortage resolved
FDA determined the shortage of semaglutide injection products (Ozempic and Wegovy) was resolved. 503A discretion ran 60 days to April 22, 2025; 503B discretion 90 days to May 22, 2025.
March 19, 2025
503B enforcement discretion for tirzepatide ends
April 24, 2025
District court denies the preliminary injunction on semaglutide
FDA's page states that following this decision the 503A enforcement discretion period for semaglutide ended. The 503B window continued to May 22, 2025.
May 22, 2025
503B enforcement discretion for semaglutide ends
From this date, an outsourcing facility compounding semaglutide from bulk needs the substance on the 503B bulks list, which it is not.
September 9, 2025
FDA warning letters to online sellers and telehealth firms
A group of letters dated September 9, 2025 cites false or misleading claims about compounded semaglutide and tirzepatide. Detail on the enforcement timeline page.
March 3, 2026
FDA press release: 30 telehealth companies warned
Letters cite claims implying sameness with approved products and branding that obscures who compounds the drug.
April 30, 2026
FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list
Comment period to June 29, 2026. If finalised, outsourcing facilities could not compound these drugs from bulk substance while the approved products are available.
How to read the windows
The discretion periods were not extensions of the shortage. FDA's language was that it "does not intend to take action" for violations "arising from conditions that depend on" the drug's inclusion on the shortage list. Those conditions are named in the tirzepatide order: section 503A(b)(1)(D), essentially a copy of a commercially available product; and sections 503B(a)(2)(A) and (a)(5), bulk substances and essentially a copy of an approved product. Everything else in the statute still applied during the windows, including the requirement for a valid prescription and the ban on false or misleading labelling.
What changed for each kind of compounder
For a 503A pharmacy, the end of the window meant the copy analysis came back. Compounding for a patient with a documented significant difference remained available; compounding the same thing for everyone at scale did not. The essentially a copy page walks through the test.
For a 503B facility the change was harder. Its bulk-substance condition depends on the shortage list or the 503B bulks list, and neither semaglutide nor tirzepatide is on the bulks list. FDA's April 30, 2026 proposal would make that exclusion formal.
Where to check for changes
FDA's drug shortage database is the source of truth for whether a drug is currently listed, and the GLP-1 policy page carries a "content current as of" date at the bottom. If either changes, the analysis on this page changes with it; we update the date at the top when we re-check. For what is lawful today, continue to what compounders may do now. For how FormBlends describes its own position on these dates, see its regulatory status page.
Questions people ask
Why did tirzepatide come off the list twice?
FDA first declared the shortage resolved on October 2, 2024. The Outsourcing Facilities Association sued on October 7, 2024 and on October 11, 2024 the court remanded the decision to FDA for re-evaluation at FDA's request. FDA re-evaluated and on December 19, 2024 issued a declaratory order that revoked and replaced the October decision with the same conclusion.
What did the enforcement discretion windows actually allow?
During the windows FDA said it did not intend to act against compounders for violations that depended on the drug's shortage-list status, meaning the essentially-a-copy condition in 503A and the bulk-substance and copy conditions in 503B. They were wind-down periods so patients mid-course could be transitioned, not a licence to keep enrolling.
Are the shortages over for good?
FDA said in the tirzepatide order that it will keep monitoring supply and demand and could relist a product. As of the content date on FDA's GLP-1 policy page, April 1, 2026, neither drug had been relisted.
Sources
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of April 1, 2026) Accessed September 4, 2026.
- FDA Declaratory Order, December 19, 2024: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound) Accessed September 4, 2026.
- Archived copy of the FDA GLP-1 policy page (Wayback Machine, March 13, 2026) Accessed September 4, 2026.
- FDA Drug Shortages database: tirzepatide injection (resolved) Accessed September 4, 2026.
Canonical URL: https://formblendscompounding.com/explainers/glp1-shortage-timeline. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.