FDA Peptide Compounding Regulatory Limbo Enters Month Six Since July 23-24 PCAC Vote; No Proposed Rule, No Federal Register Notice, No Interim Enforcement Policy
As of Thursday September 3, 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 extends the gray zone that began with the April 16, 2026 removal of 12 peptides from Category 2 and continues to leave compounding pharmacies operating under enforcement risk. CDER warning-letter activity to compounding pharmacies remained elevated through Q3 2026 versus prior years. 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; formal FDA rulemaking to translate PCAC recommendations into a proposed rule typically runs 6 to 18 months. The FDA Commissioner nomination of Dr. Heidi Overton continues to await Senate confirmation, with acting Commissioner Kyle Diamantas leading the agency through the interim.