FDA Category 2 additions
This is one entry from the TitrateLab Vendor Graveyard, a dated archive of peptide-market shutdowns, buyer-loss reports and enforcement actions. Documented as September 29, 2023. Evidence tier: Official or peer-reviewed record. Sources for this entry are linked inline below and annotated in the full Vendor Graveyard entry.
FDA’s list of bulk drug substances that may present significant safety risks under its interim compounding policies (“Category 2”) dates 18 entries to September 29, 2023, 16 of them peptides or peptide derivatives. Five more peptide listings for 503A compounding, placed in Category 2 in September 2023, were removed a year later after their nominators withdrew the nominations; FDA still lists them as substances that may present significant safety risks.
As archived on September 28, 2024, FDA’s Category 2 table dates these entries to September 29, 2023: BPC-157, cathelicidin LL-37, dihexa acetate, emideltide (DSIP), Epitalon, GHK-Cu for injectable routes, ibutamoren mesylate (503A), kisspeptin-10, KPV, Melanotan II, pegylated mechano growth factor (PEG-MGF), MOTs-C, Semax and thymosin beta-4 fragment (LKKTETQ) for 503A, and GHRP-2, GHRP-6, ipamorelin acetate and tranilast for 503B. Ibutamoren and tranilast are not peptides.
The five removed peptides are AOD-9604, CJC-1295, ipamorelin acetate (for 503A; it stays in Category 2 for 503B), thymosin alpha-1 and Selank acetate. FDA announced the removal on September 20, 2024, effective seven days later. The same archived FDA page lists all five under “Other bulk drug substances that may present significant safety risks”, and explains that such a substance “might not appear in category 2 because, for example, its nomination was withdrawn.”
For BPC-157 FDA lists possible immunogenicity, “complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization”, and little safety information for the proposed routes. For KPV it reports no human exposure data identified.
Why it matters: these listings are the starting point for the 2024 lawsuit and settlement, the April 2026 removals and the July 2026 advisory votes recorded under Regulatory milestones.
Evidence tier: Official or peer-reviewed record.
Sources: FDA, “Certain bulk drug substances for use in compounding that may present significant safety risks”, as archived September 28, 2024; Reed Smith, via Mondaq, October 4, 2024, on the September 20, 2024 removals.