FDA Law Blog Releases Two-Part "Pep(tide) Rally" Regulatory Analysis for Compounders Ahead of July PCAC
Hyman, Phelps & McNamara's FDA Law Blog published a comprehensive two-part analysis April 22 walking compounders and peptide industry stakeholders through the Federal Register notice, the July 23-24 PCAC meeting structure, the distinction between Category 2 removal and Section 503A Bulk Drug Substances List inclusion, and the notice-and-comment rulemaking that must follow any PCAC recommendation. The analysis emphasizes that the July 9, 2026 written comment deadline and June 30 oral presentation notification are critical inflection points for industry engagement.