Are Closed System Drug-Transfer Devices (CSTDs) mandatory for compounding hazardous drugs (HDs)?

Closed System Drug Transfer Devices (CSTDs) are not mandated for compounding hazardous drugs; rather, their use is recommended as a best practice. The United States Pharmacopeia (USP) General Chapter 800 highlights the importance of minimizing the risk of exposure to hazardous drugs through the use of appropriate engineering controls and practices. CSTDs are designed to prevent the transfer of environmental contaminants into the drug container and to minimize the risk of drug exposure for healthcare workers.

While CSTDs provide an additional layer of safety and are strongly encouraged in settings that handle hazardous drugs, their use is not an absolute requirement for all facilities compounding these drugs. Facilities are permitted to choose alternative methods, as long as they can demonstrate that their processes meet the necessary standards for safety and efficacy. This flexibility allows for the use of various protective measures, depending on the resources and specific situations of each facility.

In summary, the recommendation for CSTD use aims to enhance safety in the handling of hazardous drugs, but there is no strict regulatory requirement making their use compulsory. This reflects the regulatory body's understanding of different operational capabilities and the need for professional judgment in establishing safe practices.