FDA Peptide Compounding Regulatory Limbo Enters Seventh Week Since July 23-24 PCAC Vote; No Proposed Rule, No Interim Enforcement Policy
As of Saturday September 5, 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 extended six weeks past the vote and continues to leave compounding pharmacies operating 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 has 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 with acting Commissioner Kyle Diamantas leading the agency through the interim.