FDA Peptide Compounding Regulatory Limbo Continues 44 Days After July 24 PCAC Meeting; Still No Proposed Rule, No Federal Register Notice
As of Sunday September 6, 2026, the FDA has issued no proposed rule, no Federal Register notice, and no interim enforcement policy following the July 23-24, 2026 Pharmacy Compounding Advisory Committee (PCAC) vote to recommend six peptides — BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon — for inclusion on the Section 503A Bulk Drug Substances List. The regulatory silence has now lasted 44 days since the meeting ended on July 24, and compounding pharmacies continue to operate in the gray zone that began with the April 16, 2026 removal of 12 peptides from Category 2. Center for Drug Evaluation and Research warning-letter activity to compounding pharmacies remained elevated through Q3 2026. The February 2027 PCAC meeting to consider cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II, and pegylated mechano growth factor (PEG-MGF) remains scheduled. Dr. Heidi Overton (nominated FDA Commissioner August 19, 2026) continues to await Senate confirmation. Formal FDA rulemaking to translate the July PCAC recommendation into a proposed rule and then a final rule typically runs 12 to 24 months from PCAC vote; the interval of just over six weeks is within the normal window but longer than industry advocates had modeled.