The Department of Health and Human Services (HHS) announced Wednesday it will temporarily permit compounding pharmacies to produce six peptides under prescription.
These peptides include BPC-157, TB-500, epitalon, MOTS-c, KPV, and semax. They have been marketed online for various purported benefits, such as tissue repair and skin improvement, with some promotions suggesting longevity effects, though scientific evidence supporting these claims is unclear.
HHS stated that the policy is driven by concerns for safety and freedom. "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 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."
The announcement follows a July vote by an independent FDA panel to recommend these six peptides for inclusion on the 503A bulks list, which designates ingredients that compounding pharmacies can utilize for specialized or individualized prescriptions.
Peptides are molecules that can be synthesized for medicinal purposes, similar to FDA-approved drugs like insulin and GLP-1 medications. However, the agency noted that there are no published clinical trials demonstrating the effectiveness of these specific peptides in humans for any condition.
Medical professionals have cautioned that unregulated peptide products may not align with their advertised contents and could be contaminated or inaccurately dosed. In 2023, the FDA had classified 19 peptides as unsafe for compounding, a practice where pharmacies mix ingredients tailored to a specific patient. HHS Secretary Robert F. Kennedy Jr. had previously asserted that such FDA actions were illegal.