An FDA advisory committee has voted by a majority to recommend broader access to certain peptides. Peptides are short chains of amino acids that help regulate functions such as metabolism, growth, and tissue repair.
What are Peptides?
Some peptides are used in FDA-approved medications, including insulin and GLP-1 weight-loss drugs, while others are experimental compounds marketed for wellness or performance that remain under federal review.
The FDA’s Pharmacy Compounding Advisory Committee reviewed seven peptides during a two-day hearing held in Maryland last week. The panel considered whether each peptide should be added to the Section 503A Bulks List.
What’s Next?
If ultimately approved by the FDA, licensed compounding pharmacies could prepare them for valid prescriptions instead of leaving patients to rely on unregulated online vendors. The committee voted in favor of loosening restrictions on six peptides.
Jim LaValle, a Texas-based clinical pharmacist and chair of the International Peptide Society, who testified at the hearings, noted that restrictions still exist. LaValle said his work with the International Peptide Society focuses on training clinicians about the potential benefits and risks of peptide therapies as interest in the compounds grows.
LaValle emphasized that the advisory committee’s vote was only a recommendation, not a final FDA decision, and noted that compounded medications are regulated differently than FDA-approved drugs.
Original reporting: Fox News (HLL/CB) — read the source article.