On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend that six of seven nominated peptides be added to the Section 503A bulk drug substances list, the list of ingredients that state-licensed pharmacies may use to compound medicines for individual patients. The committee recommended BPC-157, KPV, TB-500 (thymosin beta-4 fragment), MOTS-c, epitalon, and semax, and voted against emideltide (delta sleep-inducing peptide, DSIP).
The two most closely watched substances, BPC-157 and KPV, each passed 8–6 with one abstention, according to reporting on the meeting; TB-500 passed by the same margin. The votes reverse the practical status quo: BPC-157 had previously sat in Category 2 of the 503A interim list, the bucket of substances FDA flagged over safety or data gaps and effectively kept out of compounding.
FDA review staff had recommended against inclusion. Agency scientists described BPC-157 as "not well-characterized," said quality standards could not be established without more data, and cited the absence of randomized controlled trials in humans. Reported adverse events discussed at the meeting included a patient who developed shortness of breath and went to an emergency room after a BPC-157 injection, though causality was not established.
PCAC recommendations are advisory and do not bind the FDA. Before any of these peptides can lawfully be compounded, the agency must issue a proposed rule, take public comment, and finalize it — a notice-and-comment process that can take more than a year — with sign-off from the Secretary of Health and Human Services. Until final rulemaking is in place, compounding these substances remains outside the 503A pathway.