Compounded tirzepatide: Status (October 2026)

Status

Item	Status	Since	Source
FDA drug shortage list, tirzepatide injection	Resolved	Dec 19, 2024	FDA drug shortage database
Grace period for 503A pharmacies	Ended	Mar 2025	FDA, 3/10/2025 update
Grace period for 503B outsourcing facilities	Ended	Mar 19, 2025	FDA, 3/10/2025 update
503A copies of an approved drug	FDA does not intend to act at four or fewer prescriptions a month	Apr 1, 2026	FDA, 4/1/2026 update
503B bulks list	FDA proposed excluding tirzepatide; comments closed Jun 29, 2026	Apr 30, 2026	FDA press announcement
Mass-marketed compounded GLP-1s	FDA announced intent to restrict GLP-1 APIs for them	Feb 6, 2026	FDA press announcement
FDA approval of compounded versions	Not FDA-approved	Standing	FDA compounding Q&A

FDA’s shortage list today

Straight from FDA’s drug shortage database, last updated by FDA in October 2026.

semaglutide: being discontinued (Rybelsus).
tirzepatide: not on the list.
liraglutide: in shortage (Liraglutide, Saxenda, Victoza); being discontinued (Liraglutide, Saxenda).

FDA drug shortage database · read through openFDA · discontinuation is a maker’s decision, not a shortage

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 October 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 October 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 October 2026

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

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

Status

FDA’s shortage list today

In the regulator’s own words

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