Is there still a GLP-1 shortage?

Is there still a shortage?

• In its April 1, 2026 update, FDA says semaglutide and tirzepatide are not on its drug shortage list.Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list.fda.gov, Sep 29, 2026(page dated Apr 1, 2026)
• FDA declared the semaglutide injection shortage resolved on February 21, 2025. It had been in shortage since 2022.[2/21/2025] FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.fda.gov, Sep 29, 2026(page dated Feb 21, 2025)
• FDA declared the tirzepatide injection shortage resolved on December 19, 2024, after re-evaluating its first decision.[12/19/2024] FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. Today, FDA has issued a new decision determining the tirzepatide injection shortage is resolved.fda.gov, Sep 29, 2026(page dated Dec 19, 2024)
• FDA says the maker's supply can meet demand, though a local pharmacy may still run short now and then.FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.fda.gov, Sep 29, 2026(page dated Feb 21, 2025)
• FDA calls a shortage resolved when supply is no longer outpaced by demand or projected demand.Resolved - A shortage is considered resolved when FDA determines that supply is no longer exceeded by demand or projected demand.fda.gov, Sep 29, 2026(page dated Dec 18, 2024)
• Resolved shortages stay on FDA's shortage page for only 6 months.Resolved shortages remain on the webpage for 6 months and discontinued shortages remain on the webpage for 1 year.fda.gov, Sep 29, 2026(page dated Dec 18, 2024)

What that means for compounded versions

• Once a shortage is resolved, FDA generally treats the drug as commercially available.When a drug shortage is resolved, FDA generally considers the drug to be commercially available.fda.gov, Sep 29, 2026(page dated Oct 2, 2024)
• FDA says it does not intend to act against a compounder that fills four or fewer prescriptions a month of a copy of a commercially available drug.FDA has stated, at this time, it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month.fda.gov, Sep 29, 2026(page dated Apr 1, 2026)
• Semaglutide: state-licensed pharmacies and physicians were given until April 22, 2025 to stop making copies.For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today’s announcement, until April 22, 2025.fda.gov, Sep 29, 2026(page dated Feb 21, 2025)
• Semaglutide: outsourcing facilities were given until May 22, 2025.For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today’s announcement, until May 22, 2025.fda.gov, Sep 29, 2026(page dated Feb 21, 2025)
• Tirzepatide: state-licensed pharmacies were given until February 18, 2025.For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing tirzepatide injections within 60 calendar days from today’s announcement, until February 18, 2025.fda.gov, Sep 29, 2026(page dated Dec 19, 2024)
• Tirzepatide: outsourcing facilities were given until March 19, 2025.For outsourcing facilities under section 503B compounding, distributing or dispensing tirzepatide injections within 90 calendar days from today’s announcement, until March 19, 2025.fda.gov, Sep 29, 2026(page dated Dec 19, 2024)
• On April 30, 2026, FDA proposed keeping semaglutide, tirzepatide and liraglutide off the list of bulk drugs outsourcing facilities may compound from, finding no clinical need.The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.fda.gov, Sep 29, 2026(page dated Apr 30, 2026)
• Comments on that proposal were due June 29, 2026.The FDA is now inviting interested parties to submit comments electronically through the docket by June 29, 2026.fda.gov, Sep 29, 2026(page dated Apr 30, 2026)

Not found on an official page: A final FDA decision on the April 30, 2026 proposal.