HHS to allow compounding pharmacies to prepare six unapproved peptides

Health and Human Services Secretary Robert F. Kennedy Jr. has taken steps to permit compounding pharmacies to prepare six specific peptides that lack FDA approval, according to a draft policy filed Wednesday and reported by CBS News.

The peptides named in the policy are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. These substances are often marketed with health claims despite not having FDA approval for safety and effectiveness.

Kennedy's policy states that compounding pharmacies and physicians will not face action for preparing drugs using these peptides, aiming to provide patients with a more controlled alternative and to advance patient choice and freedom while safeguarding safety.

The decision follows an FDA advisory panel vote in July recommending allowing these peptides in compounding, despite FDA scientists advising against it due to insufficient evidence on safety and effectiveness.

The Department of Health and Human Services emphasized that pharmacies will need to meet quality standards under the new policy, which reflects a shift toward easing access to these unapproved peptide drugs.