JAMA Viewpoint warns peptide compounding vote threatens the FDA approval system
Researchers at the Center for Science in the Public Interest say an FDA advisory committee vote backing six unapproved peptides, including BPC 157, for pharmacy compounding could undercut drug approval and put patients at risk.
WASHINGTON
- What's newA JAMA Viewpoint by three Center for Science in the Public Interest researchers says the July advisory committee vote to add six peptides to the 503A Bulks List threatens the drug approval process and patients.
- Why it mattersThe Bulks List is the only lawful compounding route for these peptides, and listing them would let pharmacies supply substances that no company has proven safe and effective to the FDA.
- What's nextThe votes are nonbinding. The FDA must decide whether to propose rules, with public comment, a process reported to run into 2027.