RFK Jr. Draft Policy Allows Compounding Pharmacies to Prepare Six Unapproved Peptides

Health and Human Services Secretary Robert F. Kennedy Jr. filed a draft policy on Wednesday that permits compounding pharmacies to prepare six specific peptides that have not yet received approval from the Food and Drug Administration. The substances covered by the new guidance are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.

Kennedy stated in the document that allowing limited compounding under appropriate safeguards offers patients a more controlled alternative. The policy explicitly notes that the department did not intend to take action against licensed pharmacies or physicians who compound drug products using these peptide bulk substances, even when the substance is not part of an FDA-approved drug.

Although these peptides are small proteins with powerful effects, they remain unapproved by the federal agency. Kennedy referenced a July vote by an FDA panel that recommended allowing the use of these six peptides in compounding. That recommendation went against the advice of FDA scientists, who argued there was insufficient evidence of safety and effectiveness for a formal determination.

The HHS spokesperson noted that the policy does not grant FDA approval or establish clinical safety and effectiveness. Instead, it requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting. These measures are designed to hold compounders accountable and provide an alternative to unregulated sellers.

The draft policy imposes strict requirements on the supply chain. It mandates the use of an FDA-registered ingredient maker, a lab certificate for raw ingredients, and the reporting of serious side effects. An HHS spokesperson told CBS News that these steps help patients know what is in the drugs currently sold by unregulated sources.

The timing follows a recent laboratory test on an experimental drug called retatrutide. The sample was purchased from a bodega in Brooklyn, New York, but the test revealed it did not contain a peptide at all. A CBS News investigation last summer found that dozens of clinics with licensed staff have advertised retatrutide, despite it remaining in clinical trials by Eli Lilly and lacking an FDA review.

The public can submit comments on the draft policy starting Friday and continuing through November 13. The policy will remain in effect until the FDA finalizes a rule regarding compounded peptides, although the agency has not yet proposed such a rule.