FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list

An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on the agency’s 503A bulk-compounding list.

The 503A Bulks List identifies drugs that can be compounded in larger quantities by pharmacies, allowing clinicians to create patient-specific formulations. Adding the peptides would give compounding pharmacies a regulatory pathway to produce them for off-label or investigational uses.

While the recommendation moves the peptides closer to wider clinical use, it does not constitute final FDA approval. The agency will still need to review the proposal before the list can be officially updated.