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 on federalregister.gov

  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 on federalregister.gov

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

    Not legalizedView on frierlevitt.com

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

    Not legalizedView on boesensnowlaw.com

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 TB-500 (Thymosin Beta-4) - Removed from FDA Category 2 after nominations were withdrawn - but it was never in Category 1, so it is still not legal to compound.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

  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 on federalregister.gov

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

    Review scheduledView on federalregister.gov

  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 on federalregister.gov

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

    EnforcementView on mcdermottlaw.com

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

    EnforcementView on pharmacytimes.com

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

    Not legalizedView on federalregister.gov

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

    Not legalizedView on federalregister.gov

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

    Not legalizedView on a4pc.org

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 Selank - Removed from Category 2 after its nomination was withdrawn - not placed on the 503A list, so compounding remained unauthorized.

    Not legalizedView on onhealthcare.tech