Are compounded GLP-1 products still allowed after shortage resolution?
“Compounded tirzepatide and semaglutide are still legal now that the shortages are over.”
Correct wording
FDA resolved the national shortages of tirzepatide (Dec. 19, 2024) and semaglutide (Feb. 21, 2025). After transition periods, compounded copies are generally subject to the usual 503A/503B copy restrictions; local stock-outs do not create a continuing shortage.
Not legal or medical advice.
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Why this is confusing
Patients may still see intermittent pharmacy stock issues and mistakenly believe the national shortage continues.
Sources
- Declaratory Order: Resolution of Shortages of Semaglutide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages
- Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages