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 compounded semaglutide 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, and the FDA is enforcing that limit. On September 18, 2026 it warned Empower Pharmacy, a Houston compounding pharmacy, that its semaglutide/cyanocobalamin (vitamin B12) injections appear to be essentially copies of the approved drug; the letter points to “significant difference” statements repeated verbatim across many prescriptions, which suggests they were pre-generated for prescribers to pick rather than written for an individual patient.

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 Oct 9, 2026 (ET) · status held since Apr 22, 2025

Primary source: Federal Register All 14 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

Sep 18, 2026
FDA warning letter to Empower Pharmacy, a Houston compounding pharmacy: its semaglutide/B12 injections appear to be essentially copies of the approved drug. No rule changed; routine compounding of copies was already restricted.
EnforcementView on fda.gov
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, as announced; the FDA’s Sep 2026 Empower letter dates it Apr 24) / May 22, 2025 (503B); FDA proposed permanent 503B exclusion (Apr 2026). Narrow patient-specific 503A exception remains. Sep 18, 2026: FDA warning letter to Empower Pharmacy over semaglutide/B12 injections that appear to be essentially copies.
Australia (TGA)	Restricted	GLP-1 analogues removed from the pharmacist compounding exemption effective Oct 1, 2024; remains Schedule 4.
United Kingdom (MHRA)	Restricted	Licensed prescription-only medicine; unlicensed copies may not be supplied where the licensed product can meet the patient’s need, and MHRA enforces against unlicensed semaglutide products.
European Union (EMA)	Restricted	Centrally authorised prescription-only medicine; compounded versions hold no EU marketing authorisation, with enforcement against unlicensed supply handled at member-state level.
Canada (Health Canada)	Restricted	Authorized prescription-only medicine (Ozempic, Wegovy), and generic semaglutide has been on sale since May 2026 (Dr. Reddy’s from May 6, Apotex from May 14); both had Type II recalls in Aug-Sep 2026 (an impurity out of specification; a pen showing the wrong dose). Compounded copies of marketed drugs are not permitted outside a shortage, and Health Canada has recalled compounded semaglutide made with an unauthorized API.
Sport / anti-doping (WADA)	Unscheduled	Not prohibited; on the WADA Monitoring Program since 2024. WADA confirmed GLP-1 status is unchanged for 2027 (Sep 21, 2026).

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

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.
FDA - warning letter, Empower Pharmacy (Sep 18, 2026) FDA · primarySemaglutide/cyanocobalamin injections appear to be essentially copies of FDA-approved semaglutide; “significant difference” statements repeated verbatim across many records.
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.
Health Canada recall - compounded Semaglutide + Pyridoxine (21 Jan 2025) Health Canada · primaryBasis for the Canada (Health Canada) status row.
EMA - Ozempic (semaglutide) EPAR EU · primaryBasis for the European Union (EMA) status row.
WADA - 2027 Prohibited List published (Sep 21, 2026) WADA · primaryThe 2027 List takes effect Jan 1, 2027.
Health Canada Drug Product Database - Dr. Reddy’s Semaglutide Injection Health Canada · primaryGeneric semaglutide, marketed since May 6, 2026.
Health Canada Drug Product Database - Apo-Semaglutide Injection Health Canada · primaryGeneric semaglutide, marketed since May 14, 2026.
Health Canada recall - Dr. Reddy’s Semaglutide Injection, impurity out of specification (Aug 27, 2026) Health Canada · primaryType II recall.
Health Canada recall - Apo-Semaglutide Injection, incorrect dose display (Sep 25, 2026) Health Canada · primaryType II recall: the affected lot may show and deliver 0.25 mg or 0.5 mg instead of 1 mg.
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.
GOV.UK - MHRA: No summer shortcut for safe weight loss (24 Jul 2026) AnalysisBasis for the United Kingdom (MHRA) status row.

Last verified by a human: Oct 9, 2026 (ET) · how we verify
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