U.S. regulatory status

Semaglutide (compounded)

Also known as Ozempic · Wegovy · compounded semaglutide

RestrictedEnforcement discretion ended; routine compounding no longer permitted. 503B exclusion proposed - comments closed Jul 30, 2026, decision pending

Is Semaglutide (compounded) legal right now?

Semaglutide is an FDA-approved drug (Ozempic, Wegovy), not a 503A bulk substance. Pharmacies were permitted to compound copies of it only while it sat on the FDA drug-shortage list. After the FDA declared the shortage resolved in February 2025, that permission wound down - ending April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities - and the FDA now treats mass compounding of "essentially a copy" of the approved drug as an actionable violation. A narrow exception survives for patient-specific products that are not essentially a copy. In April 2026 the FDA proposed to permanently exclude semaglutide - along with tirzepatide and liraglutide - from the 503B bulks list; the public comment period closed July 30, 2026 (extended from June 30) and the FDA's final determination is pending, with no announced date.

Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.

Verified Aug 11, 2026 (ET) · status held since Apr 22, 2025

Primary source: Federal Register All 5 sources Reconstitution calculator Compared: vs Ozempic / Wegovy Compared: vs Tirzepatide

Where it sits in the process

Nominated (passed)
Under review (passed)
Rulemaking (stalled here - not advancing)
Compounding-legal (not reached)

Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.

What changed last

Jul 30, 2026
Public comment period closed on the FDA's proposal to permanently exclude semaglutide from the 503B bulks list (extended from June 30). The proposal is not final - the FDA is now reviewing the record, with no announced decision date.
Comment deadlineView on govinfo.gov
Apr 30, 2026
FDA proposed to permanently exclude semaglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. This is a proposal in a comment period, not a final change.
Review scheduledView on federalregister.gov
May 22, 2025
503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage.
EnforcementView on mcdermottlaw.com

Status elsewhere

Semaglutide (compounded): regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Restricted	Enforcement discretion ended Apr 22, 2025 (503A) / May 22, 2025 (503B); FDA proposed permanent 503B exclusion (Apr 2026). Narrow patient-specific 503A exception remains.
Australia (TGA)	Restricted	GLP-1 analogues removed from the pharmacist compounding exemption effective Oct 1, 2024; remains Schedule 4.
Sport / anti-doping (WADA)	Unscheduled	Not prohibited; on the WADA Monitoring Program since 2024.

Sources & transparency

Sources for this entry

Federal Register - 503B bulk drug substances clinical-need proposal (FR 2026-08552) Federal Register · primaryMay 1, 2026 proposal not to include semaglutide, tirzepatide, and liraglutide on the 503B bulks list (Docket FDA-2018-N-3240); set the original June 30, 2026 comment deadline.
Federal Register - comment-period extension (FR 2026-12937) Government · primaryJune 26, 2026 notice extending the comment deadline on the 503B exclusion proposal to July 30, 2026.
McDermott - semaglutide shortage resolved; compounding wind-down analysis503A enforcement discretion ended Apr 22, 2025; 503B ended May 22, 2025; narrow exceptions only.
Alston & Bird - FDA resolves semaglutide shortage analysisContinued compounding only of products not 'essentially a copy' for individual patient needs.
EMJ - GLP-1 receptor agonists on WADA Monitoring Program analysisSemaglutide monitored, not prohibited.

Last verified by a human: Aug 11, 2026 (ET) · how we verify
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