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Regulatory & research

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.

How to read this

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.

§ 01 / Where things stand

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 That basis has been withdrawn: the molecules came off the shortage list, the enforcement grace periods lapsed in 2025, and the FDA has now proposed excluding them from the 503B bulks list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.

  1. Dec 2024FDA removes tirzepatide from the drug shortage list.
  2. Feb 2025FDA removes semaglutide from the shortage list.
  3. Apr 22 2025503A compounding grace period for these GLP-1s ends.
  4. May 22 2025503B outsourcing-facility grace period ends.
  5. Apr 30 2026FDA proposes excluding semaglutide, tirzepatide, liraglutide from the 503B Bulks List permanently.
  6. Jun 29 2026Public comment window on that 503B proposal closes.
  7. Jul 2026Pharmacy Compounding Advisory Committee (PCAC) review of research peptides (BPC-157, TB-500, and others).
§ 02 / Go deeper

Source-cited coverage.

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