The US health department will temporarily allow licensed pharmacies and physicians to compound six peptide ingredients while regulators consider whether to formally permit their use. The policy is not FDA approval and applies if compounders meet requirements for quality, manufacturing, safety reporting, labeling and patient-specific prescriptions.
The policy covers BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax. HHS said it would not take enforcement action against compounders using the ingredients if they meet requirements on ingredient quality, manufacturing standards, safety reporting, labeling and patient-specific prescriptions.
HHS said the policy could be reconsidered if safety signals or product-quality problems emerge, and that it does not constitute FDA approval of the peptides or compounded medicines made from them. An FDA advisory committee had recommended that the agency consider allowing all six for compounding. Analysts estimate the peptide industry could become a $2 billion to $3 billion market if legitimized; Hims & Hers Health has been preparing to roll out peptide offerings once cleared by federal regulators.
