The audit trail

What's changed

Every status change we've recorded, newest first — each one dated and linked to its primary source. This is the same feed the alert emails draw from.

Subscribe via RSS ↗ · Last updated Jul 7, 2026 (ET)

  1. Semaglutide (compounded) — FDA proposed to permanently exclude semaglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. This is a proposal in a comment period, not a final change.

    Review scheduledView source

  2. Tirzepatide (compounded) — FDA proposed to permanently exclude tirzepatide from the 503B bulks list, alongside semaglutide and liraglutide. This is a proposal in a comment period, not a final change.

    Review scheduledView source

  3. GHK-Cu — Injectable GHK-Cu removed from Category 2 without being placed on the 503A list — removal did not authorize compounding.

    Not legalizedView source

  4. Melanotan II — Moved out of Category 2 and slated for a later PCAC review — the change did not legalize compounding.

    Not legalizedView source

  5. TB-500 (Thymosin Beta-4) — Removed from FDA Category 2 after nominations were withdrawn — but it was never in Category 1, so it is still not legal to compound.

    Not legalizedView source

  6. BPC-157 — Placed on the July 23, 2026 FDA advisory committee agenda (Docket FDA-2025-N-6895); FDA's briefing proposes not adding it to the 503A list.

    Review scheduledView source

  7. Semax — Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.

    Review scheduledView source

  8. TB-500 (Thymosin Beta-4) — Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.

    Review scheduledView source

  9. Semaglutide (compounded) — 503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage.

    EnforcementView source

  10. Tirzepatide (compounded) — 503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage.

    EnforcementView source

  11. CJC-1295 — FDA advisory committee voted against adding CJC-1295 to the 503A list.

    Not legalizedView source

  12. Thymosin Alpha-1 — FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list.

    Not legalizedView source

  13. Ipamorelin — FDA advisory committee voted against adding ipamorelin to the 503A list.

    Not legalizedView source

  14. Selank — Removed from Category 2 after its nomination was withdrawn — not placed on the 503A list, so compounding remained unauthorized.

    Not legalizedView source