Health Secretary Robert F. Kennedy Jr. has unilaterally put in place a policy that allows specialty pharmacies to sell six peptide drugs, overruling scientists at the Food and Drug Administration. The rule was made available on the Federal Register on Wednesday, and its final publication is set for October 30.
The six substances are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. They are popular among supporters of Kennedy's MAHA movement, and many prominent figures in that movement, along with allies of Kennedy, sell them. Kennedy has said he uses some of the peptides himself and described himself as a "big fan."
FDA scientists have taken a different view. They continue to say there is not enough evidence to show whether the peptides work, and they warn that the drugs are potentially dangerous. Those safety concerns led the agency in 2023 to take the six peptides off a list of drugs that compounding pharmacies are allowed to make. Compounding pharmacies prepare customized formulations for individual patients or, as in this case, specialty drugs in bulk.
Kennedy's rule does not formally reverse the 2023 decision. Instead it sidesteps the need to do so. The document is titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," and it leaves the regulatory status of the peptides unchanged.
What it does change is how the rule will be applied. The Department of Health and Human Services (HHS) says it will no longer take enforcement action against compounding pharmacies for making the six peptides. In practice, that gives pharmacies a green light to produce and sell them freely, even though the FDA's earlier removal of the drugs from the approved compounding list remains in place.
The move follows an earlier step by Kennedy. The health secretary had quietly proposed the rule earlier this month, and it has now been issued in final form.
Alongside the Federal Register notice, HHS posted a more detailed explanation of the policy. That document lays out more of Kennedy's rationale for easing enforcement on the six selected peptides.
The outcome leaves a notable gap between the department's leadership and its own scientific agency. The FDA's experts say the evidence on effectiveness is lacking and the drugs may carry risks, while the policy now in effect allows pharmacies to make and sell the peptides without fear of federal enforcement.
