The U.S. Food and Drug Administration (FDA) essentially banned peptides in 2023 because of safety concerns. But an FDA committee met in July to review the evidence on peptides and recommend whether or not to take the highly unusual step of allowing pharmacies to dispense them absent scientific review. The committee was made up of new appointees who consulted with or were employed by companies that were interested in promoting or dispensing peptides; it recommended allowing specialty pharmacies to dispense six peptides, despite FDA staff advising against the move.
The new policy—which was signed by Kennedy—says that after the July meetings, HHS believed there was “significant interest” in the use of obtaining these peptides from compounding pharmacies. “Therefore, to expand and improve patient access, HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A,” the notice said. The policy said that it was going to be published in the Federal Register on Oct. 30. The peptides listed in Appendix A were BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—the same ones the committee recommended allowing this summer.