Compounding policy, tracked.
Where 503A/503B compounding stands after the 2025 shortage delistings — the dates that matter, with primary sources. Legal status here is dynamic; every claim is dated.
A working timeline, not legal advice. Dates and figures trace to primary sources (FDA, federal register, court filings) cited on the linked pages. Compounding rules are moving — recheck before acting.
The shortage era is closing.
For most of 2023–2024, mass-compounded semaglutide and tirzepatide rested on the FDA drug-shortage exemption. That basis has been withdrawn: the molecules came off the shortage list, the enforcement grace periods lapsed in 2025, and the FDA has now proposed excluding them from the 503B bulks list permanently. What remains is narrow, patient-specific 503A compounding. Full context: compounded vs branded peptides.
- Dec 2024FDA removes tirzepatide from the drug shortage list.
- Feb 2025FDA removes semaglutide from the shortage list.
- Apr 22 2025503A compounding grace period for these GLP-1s ends.
- May 22 2025503B outsourcing-facility grace period ends.
- Apr 30 2026FDA proposes excluding semaglutide, tirzepatide, liraglutide from the 503B Bulks List permanently.
- Apr 15 2026FDA removes BPC-157, TB-500 and ten other peptides from 503A Category 2 after their nominations are withdrawn.
- Jul 23–24 2026Pharmacy Compounding Advisory Committee (PCAC) votes to recommend six of seven research peptides, BPC-157 and TB-500 among them, for the 503A bulks list.
- Jul 30 2026Public comment window on that 503B proposal closes, after an extension from Jun 29.
- Oct 28 2026HHS says it will not act against licensed pharmacies compounding BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon for a named patient under ten conditions. Not an approval. The policy and its conditions.