FDA Pharmacy Compounding Advisory Committee (PCAC) Has Scheduled a Second Peptide Meeting Before the End of February 2027 to Review Five Additional Peptides for Section 503A Bulks List Inclusion Following the July 23-24, 2026 Session That Recommended 6 of 7 Peptides (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon; DSIP Rejected); The February 2027 Docket Covers Cathelicidin (LL-37, Antimicrobial Peptide With Broad Anti-Infective and Immune-Modulatory Activity), GHK-Cu (Copper Tripeptide Widely Marketed in Cosmetic and Wound-Healing Formulations), Dihexa Acetate (Angiotensin-Derived Nootropic), Melanotan II (α-MSH Analog for Skin Pigmentation and Appetite Suppression), and Pegylated Mechano Growth Factor (PEG-MGF, Muscle Repair Peptide)
The FDA Pharmacy Compounding Advisory Committee (PCAC) has scheduled a second peptide meeting before the end of February 2027 to review five additional peptides for Section 503A Bulks List inclusion. The February 2027 docket covers: cathelicidin (LL-37), a broad-spectrum antimicrobial peptide with anti-infective and immune-modulatory activity; GHK-Cu (glycyl-histidyl-lysine copper tripeptide), a widely-marketed cosmetic and wound-healing peptide previously in FDA Category 2; dihexa acetate, an angiotensin IV-derived nootropic that has been marketed for cognitive enhancement; melanotan II, an alpha-melanocyte-stimulating hormone analog marketed for skin pigmentation (self-tanning) and appetite suppression; and pegylated mechano growth factor (PEG-MGF), a muscle-repair peptide derived from insulin-like growth factor 1 splice variants. The February 2027 review continues the July 23-24, 2026 PCAC session that recommended 6 of 7 peptides for Section 503A Bulks List inclusion (BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon approved; Emideltide/DSIP rejected). FDA has not yet posted the final date and public-comment docket details for the February 2027 meeting. Under standard rulemaking timelines, the FDA's process of Notice of Proposed Rulemaking, public comment period, and final rule after any positive PCAC recommendation takes 12-24 months.