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.
Semaglutide (compounded) - Public comment period closed on the FDA's proposal to permanently exclude semaglutide from the 503B bulks list (extended from June 30). The proposal is not final - the FDA is now reviewing the record, with no announced decision date.
Tirzepatide (compounded) - Public comment period closed on the FDA's proposal to permanently exclude tirzepatide from the 503B bulks list (extended from June 30). The proposal is not final - the FDA is now reviewing the record, with no announced decision date.
Emideltide (DSIP) - FDA advisory committee (PCAC) voted 6-7, with 1 abstention, AGAINST recommending Emideltide (DSIP) for the 503A list - the only one of the seven peptides reviewed that it declined to recommend. It stays off the list, with no further FDA action scheduled.
Epitalon - FDA advisory committee (PCAC) voted 7-4, with 1 abstention, to recommend adding Epitalon to the 503A list. Advisory only - Epitalon is still not on the list and still not legal to compound until the FDA accepts the recommendation and completes rulemaking.
Semax - FDA advisory committee (PCAC) voted 8-5, with 1 abstention, to recommend adding Semax to the 503A list. Advisory only - Semax is still not on the list and still not legal to compound until the FDA accepts the recommendation and completes rulemaking.
BPC-157 - FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding BPC-157 to the 503A list, overriding the FDA's own reviewers. Widely reported as "FDA clears BPC-157" - it does not. The vote is non-binding, BPC-157 is not on the list, and compounding it is no more authorised than the day before.
KPV - FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding KPV to the 503A list, against the FDA review staff's own recommendation. Advisory only - KPV is still not on the list and still not legal to compound.
MOTS-c - FDA advisory committee (PCAC) voted 7-5, with 2 abstentions, to recommend adding MOTS-c to the 503A list, against the FDA review staff's own recommendation. Advisory only - MOTS-c is still not on the list and still not legal to compound.
TB-500 (Thymosin Beta-4) - FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding TB-500 to the 503A list - despite FDA reviewers reporting they could not identify a single human clinical study. Advisory only: TB-500 is still not on the list and still not legal to compound.
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.
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.
GHK-Cu - Injectable GHK-Cu removed from Category 2 without being placed on the 503A list - removal did not authorize compounding.
Melanotan II - Moved out of Category 2 and slated for a later PCAC review - the change did not legalize compounding.
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.
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.
Semax - Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.
TB-500 (Thymosin Beta-4) - Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.
Semaglutide (compounded) - 503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage.
Tirzepatide (compounded) - 503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage.
CJC-1295 - FDA advisory committee voted against adding CJC-1295 to the 503A list.
Thymosin Alpha-1 - FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list.
Ipamorelin - FDA advisory committee voted against adding ipamorelin to the 503A list.
Selank - Removed from Category 2 after its nomination was withdrawn - not placed on the 503A list, so compounding remained unauthorized.
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