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Status · Compounded semaglutide · checked Oct 3, 2026

Compounded semaglutide: off FDA's shortage list since Feb 2025, grace periods ended

As of Oct 3, 2026, FDA says semaglutide is not on its drug shortage list or the 503B bulks list, so pharmacies may compound it only under the ordinary limits of sections 503A and 503B; the shortage-era grace periods ended in 2025.

Julian CaraulaniFounder, PriceTracker GLP-1Sources read Oct 3

Question: Is compounded semaglutide still legal? · Checked Oct 3, 2026 · Re-checked monthly

Cheapest GLP-1 right now$69/mo at SnagRx, billed monthly. Checked Oct 2.

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Status

ItemStatusSinceSource
FDA drug shortage list, semaglutide injectionResolvedFeb 21, 2025FDA drug shortage database
Grace period for 503A pharmaciesEndedApr 2025FDA, 4/28/2025 update
Grace period for 503B outsourcing facilitiesEndedMay 22, 2025FDA, 4/28/2025 update
503A copies of an approved drugFDA does not intend to act at four or fewer prescriptions a monthApr 1, 2026FDA, 4/1/2026 update
503B bulks listFDA proposed excluding semaglutide; comments closed Jun 29, 2026Apr 30, 2026FDA press announcement
Mass-marketed compounded GLP-1sFDA announced intent to restrict GLP-1 APIs for themFeb 6, 2026FDA press announcement
FDA approval of compounded versionsNot FDA-approvedStandingFDA compounding Q&A

In the regulator’s own words

"Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list."
FDA, 4/1/2026 update, read Oct 3, 2026
"For a state-licensed pharmacy or physician compounding, dispensing or distributing semaglutide injection products under section 503A of the FD&C Act, the period of enforcement discretion (described below) has ended."
FDA, 4/28/2025 update, read Oct 3, 2026
"Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."
FDA, Compounding and the FDA: Questions and Answers, read Oct 3, 2026

This page reports what the regulator has published, in its words. It is not legal or medical advice.

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