Semaglutide

GLP-1

Recorded history of Semaglutide — FDA records, PCAC review history, and state overlays. Each entry links to its source; entries marked reported rest on reported sources; source classification alone does not authenticate a vote tally.

Latest published federal record

FDA notice recorded — does not establish list inclusion

source-event date Jun 26, 2026

Recorded status is not an eligibility determination. PCAC recommendations are advisory. Category 1 is a nomination under FDA evaluation, distinct from the final 503A Bulks List established by rulemaking. FDA’s January 2025 interim policy describes conditional enforcement discretion, not FDA approval or unconditional permission. Its Category 1 conditions include manufacturer registration, a valid certificate of analysis and all other applicable 503A conditions; that policy does not apply to Category 2. Assess the exact substance, form and route against the applicable monograph, approved-drug-component, final-list and interim-policy provisions.

FDA January 2025 interim guidance ↗

Tracker collector’s last successful poll: not available on this public page. The aggregate polling signal on the tracker index covers multiple sources.

Per-substance authority reconciliation: no documented date is provided here. A recent source event or poll does not establish complete coverage of FDA updates.

Source-event dates and recent source polls do not establish that each substance’s current eligibility has been reverified.

We do not sell, source, or supply Semaglutide. This is a monitoring record from public government sources — not a product, and not advice.

Federal history

Jun 26, 2026503B bulks listFederal
Federal action on record
Stored event summary — not a current eligibility determination: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
2026-12937 · primary source ↗
May 1, 2026503B bulks listFederal
Federal action on record
Stored event summary — not a current eligibility determination: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
2026-08552 · primary source ↗

State overlays

No MSR event recorded in the published state history for Semaglutide. State boards hold independent authority; legislation is monitored via LegiScan and board positions are added as they are verified.

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