Semaglutide and tirzepatide (GLP-1 drugs)
FDA-approved semaglutide injection products include Ozempic and Wegovy. [FDA Declaratory Order] FDA says unapproved versions of semaglutide and tirzepatide can be risky because they do not undergo FDA review before marketing, and that compounded drugs should only be used for patients whose medical needs cannot be met by an FDA-approved drug. [FDA]
The shortage listings ended
- FDA determined the tirzepatide injection shortage resolved on Oct 2, 2024, re-evaluated it, and issued a new decision on Dec 19, 2024 that it is resolved. [FDA]
- FDA determined the semaglutide injection shortage resolved on Feb 21, 2025. [FDA] [FDA Declaratory Order]
- FDA's temporary enforcement-discretion periods for compounders then ended: for tirzepatide, 503A ended after the court ruling of Mar 5, 2025 and 503B ran to Mar 19, 2025; for semaglutide, 503A ended after the court ruling of Apr 24, 2025 and 503B ran to May 22, 2025. [FDA]
What that means for compounding
When a shortage is resolved, FDA generally considers the drug commercially available. Section 503A restricts compounding "essentially copies" of commercially available drugs regularly or in inordinate amounts, and 503B restricts outsourcing facilities from making copies of FDA-approved drugs unless the approved drug is on the shortage list. [FDA] FDA has said it does not intend to take action against a 503A compounder that fills four or fewer prescriptions of such a copy in a calendar month, and that adding another ingredient such as vitamin B12 may still be considered a copy. [FDA]
Other FDA concerns about GLP-1 products
- Retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of FDA-approved drugs, and have not been found safe and effective for any condition. [FDA]
- Salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients from the approved drugs; FDA says it is not aware of a lawful basis for their use in compounding. [FDA]
- FDA has warned companies selling unapproved semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labeled "for research purposes" or "not for human consumption." [FDA]
- FDA reports fraudulent compounded products, counterfeit Ozempic, dosing-error adverse events, and, as of May 31, 2026, 990 adverse event reports tied to compounded semaglutide and more than 730 to compounded tirzepatide. FDA notes causality is not always determinable. [FDA]
Other peptides (BPC-157, TB-500 and more)
See Compounding lists for FDA's published safety concerns about peptides such as BPC-157, TB-500, CJC-1295, ipamorelin and others.