FDA Advisory Panel Backs BPC-157 for 503A Bulks List
An FDA advisory panel voted in July 2026 to recommend the inclusion of BPC-157 on the 503A bulks list. The vote was 8-6 in favor.
An advisory panel to the U.S. Food and Drug Administration (FDA) voted in July 2026 to recommend the inclusion of BPC-157 on the list of substances for compounding pharmacies under section 503A of the Food, Drug, and Cosmetic Act.
The panel's recommendation is non-binding and does not constitute FDA approval of BPC-157. FDA staff had proposed against its inclusion. A 2025 systematic review identified 35 preclinical studies and one clinical study related to the substance.
BPC-157 is a peptide that has been investigated for potential therapeutic effects, particularly concerning gastrointestinal health and wound healing. Inclusion on the 503A list would allow its use in specific, limited circumstances prescribed by physicians, without undergoing the full FDA approval process for new drugs.
The panel's decision was based on the evidence presented. The final determination regarding the inclusion of BPC-157 rests with the FDA. Current research includes preclinical investigations and limited clinical trials, with further studies potentially needed to establish safety and efficacy for broader applications.