Health and Human Services Secretary Robert F. Kennedy Jr. has introduced a draft policy that could increase access to certain unapproved peptide drugs promoted for wellness. On Wednesday, Kennedy stated that compounding pharmacies could prepare six specific peptides—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—even though the Food and Drug Administration (FDA) has not approved them.
Kennedy wrote that this policy allows limited compounding of these peptides under strict safeguards, offering patients a more controlled option. Compounding pharmacies create custom medications by mixing ingredients for individual patients.
Although these peptides lack FDA approval, they are often marketed with health benefits. The Department of Health and Human Services (HHS) will not penalize licensed pharmacies or doctors that compound drug products using peptides not included in FDA-approved medications. Peptides are small proteins with significant effects; several, like insulin, are approved by the FDA.
An FDA advisory panel in July recommended permitting the use of these peptides in compounding, but their decision did not equate to FDA approval and contradicted FDA scientists who felt insufficient safety and effectiveness evidence existed.
Kennedy highlighted the panel’s recommendation, noting that the policy expands patient choice while ensuring safety. An HHS spokesperson confirmed that pharmacies will conduct quality testing and safety reporting to help patients understand the composition of these peptide drugs, which are often sold by unregulated vendors.
The policy does not confer FDA approval or assert clinical safety and effectiveness. It mandates patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting, holding compounders accountable and providing an alternative to unregulated sources.
The draft policy stipulates that ingredients come from FDA-registered makers, have lab certification, and includes reports of serious side effects.
A CBS News inquiry recently discovered a peptide weight-loss drug, retatrutide, from a Brooklyn bodega, lacked any peptide content. This drug remains unreviewed by the FDA and is in Eli Lilly’s clinical trials, yet many clinics advertise it despite this.
Public comment on Kennedy’s draft policy is open from Friday through November 13. The policy will apply until the FDA establishes a formal rule on compounded peptides, though the FDA has not made such a proposal yet.
Contributions to this report were made by Dr. Céline Gounder, Adam Yamaguchi, and Kerry Breen.