The FDA’s review of several peptides continues to move forward following a closely watched vote by the Pharmacy Compounding Advisory Committee (PCAC), which recommended adding six peptides to the FDA’s 503A Bulks List. While the recommendation marks an important milestone, the peptides are not yet approved for compounding, and additional regulatory steps must be completed before they can become legally available through compounding pharmacies.
In an article by CNN Health, Edgar Asebey discusses what comes next. Edgar explains that even if the FDA accepts the advisory committee’s recommendations, the agency must still complete a formal notice-and-comment rulemaking process before the peptides can be added to the 503A Bulks List.
