The FDA’s Pharmacy Compounding Advisory Committee (PCAC) meeting will evaluate whether seven peptides—including BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, and emedlitide—should be added to the list of bulk drug substances that may be used by 503A compounding pharmacies. While the committee’s recommendation is advisory and not binding on the FDA, the outcome could influence future regulatory policy governing peptide compounding and access.
In an article by Law360, Edgar J. Asebey discussed how the committee’s recommendation is just one step in a broader regulatory process. He noted that it will be important to understand the committee’s rationale for its recommendations and emphasized that, regardless of the outcome, the discussion surrounding peptide regulation is far from over. Edgar also observed that the Department of Health and Human Services could pursue alternative regulatory pathways to expand access to peptide compounding, although any such action would likely face legal challenges.
To learn more about the FDA’s review of these seven peptides and what the PCAC meeting could mean for compounding pharmacies, healthcare providers, and the peptide industry, watch Frier Levitt’s webinar featuring Edgar Asebey and Jesse Dresser.
