HHS allows compounding pharmacies to temporarily offer six peptides by prescription

The Department of Health and Human Services (HHS) announced it will temporarily allow compounding pharmacies to produce six peptides by prescription, according to ABC News and NBC News. This policy means pharmacies can offer these peptides immediately without facing legal action, even though the peptides are not yet FDA approved.

The six peptides include BPC-157, TB-500, epitalon, MOTS-c, KPV, and semax, substances promoted online for uses such as tissue repair, skin improvement, and longevity. However, scientific evidence supporting these claims remains unclear, and the FDA has found insufficient data to establish their safety and effectiveness.

HHS emphasized that this policy does not grant FDA approval or confirm clinical safety. It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to ensure accountability and provide an alternative to unregulated sellers, as reported by ABC News.

The move addresses a growing gray market where peptides are sold labeled 'for research use only' to circumvent regulations. The FDA now requires compounding pharmacies to certify the identity and purity of these compounds and report any side effects, according to NBC News.

This temporary allowance follows an independent FDA panel's recommendation to add these peptides to the 503A bulks list, which permits their use in specialized prescriptions. HHS is continuing to work on a formal rule change to regulate these substances more comprehensively.