Regulatory
Apr 15, 2026
FDA announces removal of 12 peptides from the Category 2 list
Jul 23, 2026
PCAC recommends BPC-157, KPV, TB-500 and MOTS-c for the 503A bulks list
Jul 24, 2026
PCAC recommends Epitalon and Semax; does not recommend DSIP
Feb 28, 2027
Remaining five peptides due for committee consideration
Advisory vote
Epitalon was recommended 7–4 (1 abstention) and Semax 8–5 (1 abstention). Emideltide (DSIP) was not recommended, 6–7 (1 abstention).
What this doesn't mean: A 'yes' vote is not approval and does not yet permit compounding; a 'no' vote is not a safety finding against a substance.
Advisory vote
The advisory committee voted 8–6 (1 abstention) on BPC-157, KPV and TB-500, and 7–5 (2 abstentions) on MOTS-c, recommending each be added to the 503A Bulk Drugs List.
What this doesn't mean: Advisory votes are recommendations. FDA must complete rulemaking before any of these can be lawfully compounded, and inclusion on the bulks list is not drug approval.
Compounding list
FDA published a notice scheduling a Pharmacy Compounding Advisory Committee meeting and said it would remove twelve peptides from Category 2 of its interim 503A bulks list after nominators withdrew their nominations.
What this doesn't mean: Removal from Category 2 does not make a substance eligible for compounding, and it is not FDA approval.