By Karim Hammam
The Department of Health and Human Services will temporarily allow compounding pharmacies to produce and sell six unapproved peptides, pausing legal action against them while a formal rule change is pursued.
Enforcement Discretion Granted
In a notice filed Wednesday, HHS said it would exercise “enforcement discretion” for the peptides BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. The substances are not on the FDA’s approved bulk drug substances list, and agency scientists have found insufficient evidence of safety and efficacy. Compounding pharmacies must certify the identity and purity of the compounds and report side effects, a new requirement.
Gray Market Concerns
The move aims to steer consumers away from a growing “gray market” where peptides are sold as “for research use only.” Health Secretary Robert F. Kennedy Jr., who has called himself a “big fan” of peptides, argues that regulated compounding would provide safer products. An HHS spokesperson said the action puts prevention and patient safety at the center of health care.
Critics Warn of Risks
Former FDA official Dr. Peter Lurie said the agency is “turning a blind eye” to unproven drugs. Shabbir Safdar of the Partnership for Safe Medicines warned that the policy exposes Americans to “untested dangerous substances.” An FDA advisory panel narrowly voted in July to add the peptides to the bulk list, though some members had industry ties and concerns about precedent.
