{"name":"GLP-1 Compounding and Access Regulatory Timeline","description":"A dated ledger of material FDA and CMS actions affecting GLP-1 compounding, access, and verification.","snapshotId":"2026-08-26","updatedAt":"2026-08-26","cadence":"Event-driven","license":"CC BY 4.0","methodology":["Include only regulator-issued events.","Record publication date separately from effective date.","Summarize the narrow operational consequence.","Link readers to the regulator for current legal interpretation."],"columns":[{"key":"date","label":"Date","definition":"Publication or effective date."},{"key":"authority","label":"Authority","definition":"Issuing regulator."},{"key":"event","label":"Event","definition":"Primary-source action."},{"key":"practical_effect","label":"Practical effect","definition":"Narrow effect stated or directly supported."},{"key":"source_id","label":"Source","definition":"Source ledger identifier."}],"rows":[{"date":"2026-04-30","authority":"FDA","event":"Proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list","practical_effect":"FDA stated it did not identify a clinical need for 503B outsourcing facilities to compound these substances from bulk under the nomination pathway","source_id":"fda-503b-bulks-proposal"},{"date":"2026-07-01","authority":"CMS","event":"Medicare GLP-1 Bridge begins","practical_effect":"Eligible Medicare Part D beneficiaries can access certain GLP-1 drugs for a published $50 monthly amount","source_id":"cms-bridge"},{"date":"2026-08-18","authority":"FDA","event":"Weekly registered outsourcing-facility list update","practical_effect":"Current registration, inspection, Form 483, recall, and action fields available for listed 503B facilities","source_id":"fda-503b-list"}],"sources":[{"id":"fda-503b-bulks-proposal","title":"FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list","publishedAt":"2026-04-30","accessedAt":"2026-08-26","sourceType":"regulatory"},{"id":"cms-bridge","title":"Medicare GLP-1 Bridge","publisher":"Centers for Medicare & Medicaid Services","url":"https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge","accessedAt":"2026-08-25","sourceType":"regulatory"},{"id":"fda-503b-list","title":"Registered Outsourcing Facilities","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities","accessedAt":"2026-08-25","sourceType":"regulatory"}],"findings":[{"id":"finding-1","text":"Access policy and compounding policy are moving independently.","url":"https://formblends.com/report/data/glp1-regulatory-timeline#finding-1"},{"id":"finding-2","text":"Regulatory pages should be rechecked before any availability claim is published.","url":"https://formblends.com/report/data/glp1-regulatory-timeline#finding-2"},{"id":"finding-3","text":"A proposal, effective program, and registration-list update have different legal weight and should not be blended.","url":"https://formblends.com/report/data/glp1-regulatory-timeline#finding-3"}],"caveats":["This is an editorial timeline, not legal advice.","Proposals are not final rules unless the regulator says otherwise."],"attribution":"FormBlends Research, GLP-1 Compounding and Access Regulatory Timeline, snapshot 2026-08-26"}