The department commits not to take enforcement action against pharmacies for making the drugs. The policy does not grant approval or establish safety or effectiveness, but opens a route to supply.
The US Department of Health and Human Services (HHS) made public a policy on October 28 committing not to take enforcement action against compounding pharmacies for making six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The change opens a route for those pharmacies to supply the drugs without changing their regulatory status.
Compounding pharmacies prepare customized drug formulations for patients. In 2023, safety concerns led the Food and Drug Administration (FDA) to remove the six peptides from a list of substances those pharmacies could use. The new policy sidesteps formally reversing that decision: it changes enforcement rather than granting FDA approval.
FDA scientists continue to say there is insufficient evidence that the peptides are effective and that they are potentially dangerous. Allowing pharmacies to compound them does not establish their safety or effectiveness.
HHS argues that compounded peptides offer a more controlled alternative to black-market products and foreign-made peptides labeled for research use only. The department says access through pharmacies will discourage patients from buying those products while advancing patient choice and protecting safety.
The department characterizes the safety concerns as mainly hypothetical or inferred, rather than based on observed harm in humans. Human studies showing either benefits or harms from these peptides are few or absent.
HHS also cites a July advisory-panel vote recommending that the six peptides return to the compounding list. Ars Technica said US Health Secretary Robert F. Kennedy Jr. had appointed eight new members to the 12-member panel before that vote. At least six of those appointees had ties to peptide-related businesses or clinics, ties the outlet described as raising conflict-of-interest concerns.
Kennedy proposed the enforcement policy earlier in October. He has said he uses some of the peptides and called himself a “big fan.”
Brigham Buhler, who runs a wellness clinic that sells peptides, welcomed the policy as a step forward for “medical freedom.” Zachary Shurtleff, a marketing executive at a wellness-focused compounding pharmacy, also celebrated the change. Lee Rosebush, chair of the American Academy of Peptide Medicine, thanked Kennedy and described the approach as “forward-thinking” and “evidence-based.”
The Center for Science in the Public Interest opposed wider access in an October 27 statement, warning that reports of harm would continue to mount. The group also said widespread availability could reduce pharmaceutical companies’ incentive to conduct thorough clinical trials if a peptide showed promise. It warned that granting access in response to marketing demand could encourage sales of other unapproved products.
Fred Mills, chief policy officer of Americans for Safe and Effective Medicines, said on October 28 that the policy would not resolve problems with untested products, safety risks, questionable ingredients or misleading claims. He predicted that insufficient oversight would worsen harm from mass compounding.
The policy was made available on the Federal Register on October 28. Formal publication is scheduled for October 30.
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