RFK Jr. Draft Policy Would Let Compounders Prepare Six Unapproved Peptides Marketed for Wellness

On Wednesday, Health and Human Services Secretary Robert F. Kennedy Jr. filed a draft policy that could widen access to a group of peptide drugs promoted for wellness but never approved by the Food and Drug Administration. In it, Kennedy said he had determined that compounding pharmacies may prepare six specific peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.

Compounding pharmacies mix ingredients to make customized medications for individual patients. None of the six peptides has FDA approval, yet all are often sold with health claims attached. The draft says HHS "did not intend to take action" against licensed pharmacies or physicians who compound a drug using a peptide bulk substance that is not a component of an FDA-approved drug product.

Peptides are small proteins that can have powerful effects. Some, like insulin, are approved as safe and effective, and the GLP-1 medications used for weight loss and diabetes also contain FDA-approved peptides. The six in Kennedy's policy are not in that category.

Kennedy wrote that limited compounding under appropriate safeguards gives patients "a more controlled alternative." He said the policy advances patient choice and freedom while appropriately protecting safety. He pointed to a recommendation from an advisory panel that voted in July to allow the six peptides to be used in compounding. That vote was not an FDA approval, and it went against the advice of the FDA's own scientists, who said the evidence on safety and effectiveness was insufficient for each of the six to support such a determination.

An HHS spokesperson, in a statement to CBS News, stressed the limits of the move. The policy, the spokesperson said, does not grant FDA approval or establish clinical safety and effectiveness. It requires patient-specific prescriptions, traceable ingredients, quality testing and safety reporting, which the department says will hold compounders accountable and give patients an alternative to unregulated sellers. Under the draft, pharmacies would need an FDA-registered ingredient maker, a lab certificate for the raw ingredients, and reports of serious side effects. HHS argues this would help patients know what is in peptide products now sold by unregulated sources.

The unregulated market is the backdrop. Last week, a laboratory tested a sample of retatrutide, an experimental drug, bought at a bodega in Brooklyn, New York. The sample contained no peptide at all. Retatrutide is a different drug from the six in the policy and remains in clinical trials by Eli Lilly. A CBS News investigation last summer found dozens of clinics nationwide, staffed by licensed physicians and nurse practitioners, openly advertising it despite the lack of FDA review.

The draft policy opens for public comment Friday and runs through Nov. 13. It stays in place until the FDA finalizes a rule on compounded peptides. As of now, the FDA has not proposed one.