WASHINGTON (dpa-AFX) - The U.S. Department of Health and Human Services has temporarily allowed licensed pharmacies and physicians to compound certain unapproved peptide ingredients while regulators consider whether to formally permit their use in compounded medicines.
The interim policy covers six peptides, including BPC-157 and TB-500, which are promoted for tissue repair and other wellness uses. It also includes epitalon, KPV, MOTS-c and Semax, marketed for conditions ranging from insomnia and inflammation to obesity and migraines.
HHS said it would not take enforcement action against compounders using the peptides if they meet requirements covering ingredient quality, manufacturing standards, safety reporting, labeling and patient-specific prescriptions. The policy does not constitute FDA approval of the peptides or the medicines made from them.
The move follows an FDA advisory panel recommendation to allow the six peptides for compounding, despite concerns from FDA staff about their safety and effectiveness. Health Secretary Robert F. Kennedy Jr. has publicly supported broader access to peptide treatments.
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