FDA Product Code ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Handling hazardous chemotherapy drugs poses significant risks to healthcare workers. FDA product code ONB covers closed-system drug reconstitution and transfer devices for antineoplastic and hazardous drugs.

These systems mechanically prevent the escape of hazardous vapors and aerosols during the preparation and transfer of chemotherapy agents, protecting pharmacy staff and nurses from toxic exposure while maintaining drug sterility.

ONB devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Epic Medical Pte. , Ltd., Simplivia Healthcare , Ltd. and Care Fusion.