FDA Category 2 peptide list

What "Category 2" means

Under FDA's interim compounding policy, bulk drug substances nominated for the §503A or §503B bulks lists that "may present significant safety risks" are placed in Category 2. The designation reflects FDA-identified risk during review — it is not an approval, and not a DEA schedule. Page content current as of 2026-04-22.S1

Which peptides are in Category 2

An active table currently lists GHRP-2 (503B), GHRP-6 (503B), ipamorelin acetate (503B), and kisspeptin-10 (503A).S1 A larger "nominated but withdrawn" group — peptides once nominated whose nominations were later pulled — includes AOD-9604, BPC-157, Cathelicidin (LL-37), CJC-1295, Dihexa, Emideltide (DSIP), Epitalon, GHK-Cu (injectable), KPV, PEG-MGF, Melanotan II, MOTs-C, Selank, Semax, Thymosin-alpha 1, and the Thymosin beta-4 fragment (TB-500).S1

FDA's stated concerns

For most of these peptides FDA cites the same pattern: possible immunogenicity for certain routes of administration, complexity in peptide-related impurities and active-ingredient characterization, and "no, or only limited, safety-related information" — so the agency "lacks sufficient information to know whether the drug would cause harm".S1

What's changing (July 2026 PCAC)

The Pharmacy Compounding Advisory Committee meets July 23–24, 2026 to discuss adding several of these peptides to the 503A Bulks List, under public docket FDA-2025-N-6895 established by Federal Register notice FR doc 2026-07361.S2S3 Advisory-committee recommendations are non-binding, and list membership or category can change only after FDA's own decisions and rulemaking. As of a 2026-06-30 re-check, no list moves or category shifts had been posted and the agenda was unchanged.S1S2