Open dataset · Event-driven
GLP-1 Compounding and Access Regulatory Timeline
Each event links to the primary regulator and states what changed without extending the claim beyond the source.
Key findings from FormBlends Research
FormBlends Research finding 1
#Access policy and compounding policy are moving independently.
FormBlends Research finding 2
#Regulatory pages should be rechecked before any availability claim is published.
FormBlends Research finding 3
#A proposal, effective program, and registration-list update have different legal weight and should not be blended.
The data
| Date | Authority | Event | Practical effect | Source |
|---|---|---|---|---|
| 2026-04-30 | FDA | Proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list | FDA stated it did not identify a clinical need for 503B outsourcing facilities to compound these substances from bulk under the nomination pathway | U.S. Food and Drug Administration |
| 2026-07-01 | CMS | Medicare GLP-1 Bridge begins | Eligible Medicare Part D beneficiaries can access certain GLP-1 drugs for a published $50 monthly amount | Centers for Medicare & Medicaid Services |
| 2026-08-18 | FDA | Weekly registered outsourcing-facility list update | Current registration, inspection, Form 483, recall, and action fields available for listed 503B facilities | U.S. Food and Drug Administration |
Methodology
- 1. Include only regulator-issued events.
- 2. Record publication date separately from effective date.
- 3. Summarize the narrow operational consequence.
- 4. Link readers to the regulator for current legal interpretation.
Limits
- • This is an editorial timeline, not legal advice.
- • Proposals are not final rules unless the regulator says otherwise.
Source ledger
regulatory · accessed 2026-08-26
U.S. Food and Drug Administration
FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
regulatory · accessed 2026-08-25
Centers for Medicare & Medicaid Services
Medicare GLP-1 Bridge
regulatory · accessed 2026-08-25
U.S. Food and Drug Administration
Registered Outsourcing Facilities