HHS adopts temporary policy to let compounding pharmacies produce six unapproved peptides

HHS announced a temporary policy that grants enforcement discretion to state-licensed compounding pharmacies, federal facilities, and licensed physicians who compound six specific peptide products that have not received full FDA approval.

The move follows a July advisory committee vote recommending that these pharmacies be cleared to compound the six substances. By not pursuing enforcement actions, the agency aims to increase access to the experimental wellness therapies that have been promoted by certain political groups.

Critics note the lack of safety and efficacy data for many of the peptides, and the policy is limited in scope and duration while the FDA continues its formal review.