The FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend six of the seven peptides under review for inclusion on the Section 503A Bulks List, rejecting FDA staff recommendations that none of the substances be added. If ultimately adopted by the FDA through rulemaking, the recommendations could expand the ability of 503A compounding pharmacies to compound peptides such as BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon, while Emideltide was the only peptide not recommended. The committee’s votes are advisory only, and the FDA is not required to follow them before initiating any formal rulemaking process.
Ahead of the July 23–24 PCAC meeting, Frier Levitt Partners Jesse Dresser and Edgar Asebey hosted a webinar examining the regulatory, legal, and business implications of the FDA’s peptide review. They discussed the competing positions of FDA career scientists and HHS leadership, the possible outcomes of the advisory committee meeting, and the broader implications for compounding pharmacies, healthcare providers, and companies operating in the peptide space. Now that the advisory committee has issued its recommendations, many of the issues raised during the webinar remain highly relevant. Although the vote represents a significant development for the peptide industry, it does not immediately change what may be legally compounded, and stakeholders should continue monitoring the FDA’s next steps as the agency determines whether to adopt the committee’s recommendations through the formal rulemaking process.
