Some wellness peptides will become widely available, HHS says
The Health and Human Service said Wednesday it will temporarily allow compounding pharmacies to make six peptides available by prescription.
The peptides include BPC-157, TB-500, epitalon, MOTS-c, KPV and semax. The substances have been promoted online for anything from tissue repair to better skin. Some also promote longevity, though scientific evidence on these claims remains unclear.
The HHS announcement cites safety and freedom as reasons for the decision.
"Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides," the federal health agency said in a statement. "The policy does not grant FDA approval or establish clinical safety and effectiveness. It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers."
An independent FDA panel voted in July to recommend six peptides to the 503A bulks list, which are ingredients that compounding pharmacies can use for specialized or individualized prescriptions.
Peptides are a broad term for a molecular structure. They can be synthesized such as medications like insulin and GLP-1 drugs, which have both been FDA approved for safety and efficacy following clinical trials. There are no published clinical trials that provide evidence that these specific peptides that became available today are effective in humans for any condition.
Doctors warn that these unregulated products may not be what is advertised and may be contaminated or inaccurately dosed.
In 2023, the FDA classified 19 peptides as unsafe to be compounded, a process where a specialized pharmacy mixing ingredients that are specific for a patient. HHS Secretary Robert F. Kennedy Jr. has previously claimed that action was illegal.
