RFK Jr. to ease access to unapproved peptides, draft policy states

Health and Human Services Secretary Robert F. Kennedy Jr. took steps Wednesday that could open up access to certain unapproved peptide drugs that are being promoted for wellness. Health and Human Services Secretary Robert F. Kennedy Jr. took steps this week that could open up access to certain unapproved peptide drugs that are being promoted for wellness. In a draft policy filed Wednesday, Kennedy said he had determined that compounding pharmacies could prepare six specific peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax, TB-500 — even though they do not have approval from the Food and Drug Administration. "By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative," Kennedy wrote.

Compounding pharmacies mix ingredients to prepare customized medications for individual patients. Although they are not FDA approved, the six peptides in Kennedy's new policy are often still marketed with health claims. The Department of Health and Human Services "did not intend to take action" against licensed pharmacies or physicians that compound "a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product," Kennedy's policy said. Peptides are small proteins that can have powerful effects. There are several, such as insulin, that are FDA approved as being safe and effective. GLP-1