FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list

The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ulcerative colitis, and KPV, aimed at wound treatment and other inflammatory conditions.

Both compounds have generated controversy, but the committee’s vote signals a move toward allowing pharmacies to compound them under the FDA’s existing framework for bulk drugs.

Separately, a JAMA Network Open study reported that nearly nine out of ten FDA‑approved drugs have completed their post‑marketing study requirements, with most results posted on ClinicalTrials.gov or published elsewhere.