Compounded GLP-1 Legal Status
The legality of compounded semaglutide and tirzepatide has tightened sharply since both drugs came off the FDA shortage list. This tracks what is — and isn't — permitted now.
- ChangedSemaglutide shortage statusRemoved from FDA shortage list (Feb 2025)
With semaglutide off the shortage list, the legal basis for mass compounding lapsed.
- ChangedTirzepatide shortage statusRemoved from FDA shortage list (Dec 2024)
- CurrentCompounding of semaglutide/tirzepatideBroadly no longer permitted for mass production
Limited case-by-case compounding may remain for documented medical need under 503A; mass compounding ended.
- CurrentRetatrutide / cagrilintide compoundingNot permitted
Not components of FDA-approved drugs.
How we keep this current
Our AI Librarian periodically re-checks each line against primary sources — FDA notices, manufacturer announcements, and clinical-trial registries — and re-stamps the "last verified" date above. Fast-moving regulatory facts can still change between checks; always confirm against the linked primary source before relying on any single line.