Regulatory · Reviewed 2026-06-04

Compounded GLP-1 Regulatory Timeline

How the rules for compounded semaglutide and related GLP-1 medications evolved from the 2022 shortage to the 2026 bulks-list proposal.

Quick Answer

Compounding of semaglutide became widespread during the 2022–2024 shortage. The FDA resolved the semaglutide shortage in 2025, narrowing compounding allowances, and in April 2026 proposed removing semaglutide from the 503B bulks list — which would close the remaining large-scale pathway if finalized.

Date	Event
2022	Semaglutide added to the FDA drug shortage list; broad compounding allowed under shortage conditions.
2024	Semaglutide removed from the shortage list, beginning its compounding phase-out.
Feb 2025	FDA declares the semaglutide shortage resolved, triggering a phase-out of shortage-based compounding.
2025	Enforcement and warning letters increase; 503A patient-specific compounding continues under its separate framework.
Apr 30, 2026	FDA proposes excluding semaglutide, semaglutide, and liraglutide from the 503B bulks list.
May 1, 2026	Proposal published in the Federal Register (Docket FDA-2018-N-3240).
Jun 30, 2026	Public comment deadline (per the Federal Register notice).
Pending	Final determination expected after the comment period.

Confirm current status against the Federal Register notice and FDA announcement — this timeline reflects information as of 2026-06-04.

Bottom Line

The trajectory has been a steady narrowing of compounding since the shortage ended. Check the primary sources for the latest status before relying on any compounded program.

Compounded semaglutide is not FDA-approved as a finished drug product. Compounded medications may be prescribed only when clinically appropriate and must be evaluated by a licensed prescriber. Branded medications such as Wegovy and Ozempic are FDA-approved products; compounded semaglutide is different and should not be described as FDA-approved, “generic Wegovy,” or “generic Ozempic.”