What Is Category 2? FDA classification for bulk drug substances with potential safety risks. Compounding isnot permitted. 19 Peptides Affected (Late 2023) BPC-157, TB-500, KPV, MOTS-C, Semax, Epitalon, GHK-Cu (injectable), Melanotan II, CJC-1295, Ipamorelin, Thymosin Alpha-1, and others. Recent Developments (2026) Feb 27, 2026 – RFK Jr. Announcement - Stated ~14 of 19 Category 2 peptides would move back to Category 1 - Called the 2023 reclassification "illegal" April 15, 2026 – FDA Action - 12 peptide bulk substances removed from Category 2 - ⚠️ Critical: Removal ≠ authorization to compound - Peptides remain in regulatory uncertainty July 23–24, 2026 – PCAC Meeting FDA committee to discuss adding 7 peptides to the 503A Bulks List: Day 1 (July 23): - BPC-157 (ulcerative colitis) - KPV (wound healing) - TB-500 (wound healing) - MOTS-C (obesity, osteoporosis) Day 2 (July 24): - Emideltide/DSIP (opioid withdrawal, insomnia) - Semax (cerebral ischemia, migraine) - Epitalon (insomnia) Feb 2027 – Second PCAC Meeting Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF What This Means for Researchers - PCAC recommendations are advisory only - FDA retains final authority - Rulemaking takes 12–24+ months - No formal rule change finalized yet - Access remains primarily through research suppliers Takeaway Regulatory process is ongoing. Removal from Category 2 ≠ compounding authorization. PCAC review will shape future access. 🔬 For research-grade peptides, check OrionPeptide.com. ⚠️ Research only. Not for human consumption.