US health secretary Kennedy opens access to some unapproved peptides
XLV•Robert F. Kennedy Jr. advanced a policy allowing licensed pharmacies and physicians to compound six unapproved peptides, including BPC-157 and TB-500, without FDA enforcement action if they meet specified requirements.
1. Policy permits compounding
The Federal Register published Kennedy’s interim enforcement discretion policy, allowing US pharmacies and physicians to compound six peptides while regulators consider whether to formally permit their use in compounded medicines. The peptides are BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax.
2. Safety concerns raised
Compounded drugs are not FDA-approved, and the agency does not review their safety, effectiveness or quality before they are marketed. Public Citizen’s Robert Steinbrook said the move could expose patients to contamination, impurities and unknown side effects, and argued the substances should undergo the standard FDA drug approval process.
3. Conditions and industry response
The policy says compounders must meet requirements for ingredient quality, manufacturing standards, safety reporting, labeling and patient-specific prescriptions. HHS said the interim policy aims to discourage use of research-use-only peptides from foreign manufacturers and improve patient access; it may reconsider if safety signals or product-quality problems emerge. Analysts estimate the peptide industry could become a $2 billion to $3 billion market if legitimized.
