The FDA’s recent Pharmacy Compounding Advisory Committee (PCAC) meeting continues to generate coverage following the committee’s recommendations to add several peptides to the Section 503A Bulks List. While the recommendations are not binding, they represent an important step in the FDA’s ongoing evaluation process and could ultimately expand access to compounded peptide therapies if adopted through formal rulemaking.
In its coverage of the committee’s recommendations, Mezha quoted Edgar Asebey, who explained that the committee’s vote is only one stage of a broader regulatory process.
“If FDA agrees with the PCAC’s positive recommendations, the process of actually implementing the peptide for compounding will occur through formal rulemaking and discussion of rules.”
