Peptide regulatory status has moved fast in 2026, and the terminology alone (Category 1 vs Category 2, 503A vs 503B, PCAC review) trips up most readers. This page is a single reference point we’ll keep updated as the July 23-24 PCAC meeting and its aftermath develop.
Current Status by Peptide
| Peptide | Category Status | PCAC Status |
|---|---|---|
| BPC-157 | Off Category 2 (Apr 2026) | Under review, July 23 |
| TB-500 | Off Category 2 (Apr 2026) | Under review, July 23 |
| KPV | Off Category 2 (Apr 2026) | Under review, July 23 |
| MOTS-c | Off Category 2 (Apr 2026) | Under review, July 23 |
| DSIP (Emideltide) | Off Category 2 (Apr 2026) | Under review, July 24 |
| Semax | Off Category 2 (Apr 2026) | Under review, July 24 |
| Epitalon | Off Category 2 (Apr 2026) | Under review, July 24 |
| GHK-Cu (injectable) | Off Category 2 (Apr 2026) | Scheduled for 2nd meeting, before Feb 2027 |
| LL-37 | Off Category 2 (Apr 2026) | Scheduled for 2nd meeting, before Feb 2027 |
| Melanotan II | Off Category 2 (Apr 2026) | Scheduled for 2nd meeting, before Feb 2027 |
| PEG-MGF | Off Category 2 (Apr 2026) | Scheduled for 2nd meeting, before Feb 2027 |
| Compounded semaglutide / tirzepatide | N/A | Proposed 503B bulks exclusion, comment closed June 29, 2026 |
Understanding the Terminology
Category 1 vs Category 2 refers to an older FDA classification of whether a nominated bulk substance could be considered for compounding at all. Category 2 substances were effectively barred; removal from that list is a precondition for the substance to then be nominated to the 503A bulks list.
503A vs 503B distinguishes two different types of compounding pharmacies — 503A pharmacies compound against individual patient prescriptions, while 503B outsourcing facilities can compound in larger batches without a patient-specific prescription, under stricter manufacturing standards.
PCAC is the Pharmacy Compounding Advisory Committee, the FDA advisory body voting on inclusion to the 503A bulks list. Its recommendations are non-binding.