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Status · Compounded tirzepatide · checked Oct 3, 2026

Compounded tirzepatide: off FDA's shortage list since Dec 2024, grace periods ended

As of Oct 3, 2026, FDA says tirzepatide 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 March 2025.

Julian CaraulaniFounder, PriceTracker GLP-1Sources read Oct 3

Question: Is compounded tirzepatide 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, tirzepatide injectionResolvedDec 19, 2024FDA drug shortage database
Grace period for 503A pharmaciesEndedMar 2025FDA, 3/10/2025 update
Grace period for 503B outsourcing facilitiesEndedMar 19, 2025FDA, 3/10/2025 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 tirzepatide; 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 under section 503A of the FD&C Act, the period of enforcement discretion described below has ended."
FDA, 3/10/2025 update (tirzepatide), read Oct 3, 2026
"After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances."
FDA press announcement, Apr 30, 2026, 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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