FDA Category 2 reclassification of 17 peptides
This is one entry from the TitrateLab Vendor Graveyard, a dated, primary-source archive of peptide-market shutdowns, exit scams, and enforcement actions. Documented as September 2023. Sources for this entry are named inline below and numbered in full on the parent archive page.
Not a single incident but the policy event that made the modern grey market possible.
On or around September 29, 2023, the FDA moved 17 peptide substances from its interim 503A bulks list Category 1 to Category 2. Category 2 substances are those the FDA determines “raise significant safety concerns.” The reclassification cut off legal 503A compounding access to BPC-157, TB-500, CJC-1295, Ipamorelin, AOD-9604, GHK-Cu, Selank, Semax, KPV, MOTS-C, and others overnight.
The FDA cited impurity and API characterization concerns for BPC-157 and MOTS-C, and insufficient human-exposure data for KPV among others.
Why it still matters: this is the single most important policy event in the modern peptide market’s history. Every grey-market vendor that grew to scale between 2024 and 2025 was capturing patient demand that would otherwise have flowed to compounding pharmacies. The subsequent FDA enforcement wave (against grey-market vendors, not against compounders) was in large part an attempt to manage the consequences of this reclassification.
Primary sources: FDA briefing materials for the PCAC meeting; settled into the public record via the subsequent Evexias/Farmakeio litigation (see below).