FDA advisory panel backs adding peptide BPC-157 to compounding list

The Food and Drug Administration's Pharmacy Compounding Advisory Committee voted Thursday to add the peptide BPC-157 to a drug-compounding list, with an 8-6 margin and one abstention. The non-binding decision still requires final sign-off from the FDA and is the first of seven peptides under review by the panel.

Committee members who supported the measure said they viewed the potential risks as minimal, while opponents warned that placing the peptide on the list could give the impression it has undergone the same rigorous evaluation as fully approved drugs. FDA staff scientists noted a general lack of quality data on the safety and effectiveness of BPC-157.

BPC-157, promoted online for gut and tissue healing, currently circulates mainly through unregulated channels. Human clinical trial data are limited, and most existing studies involve rodents, which do not always translate to human outcomes. The panel is considering an atypical regulatory pathway that would allow the peptide to be compounded rather than requiring full FDA approval.

The discussion also touched on broader concerns about the influence of financial conflicts of interest among newly appointed PCAC members, a point highlighted by criticism of the Health and Human Services department.