May a closed-system drug-transfer device (CACI), isolator, robotic device, or similar device be utilized to compound sterile HDs outside of a C-SEC?

The correct answer emphasizes that a closed-system drug-transfer device (CACI), isolator, robotic device, or similar device cannot be utilized to compound sterile hazardous drugs (HDs) outside of a compounding sterile environment (C-SEC). According to USP <800>, proper compounding of hazardous drugs is critical to ensure the safety of both the workers and the environment.

Compounding sterile HDs requires a controlled setting that offers adequate environmental protections and containment measures. A C-SEC is designed specifically for this purpose, providing the necessary environment to minimize exposure to hazardous substances. Utilizing compounding devices outside of this defined space would not adhere to safety protocols, potentially leading to harmful consequences for the compounders, patients, and the cleanliness of the environment.

This strict regulation helps uphold patient safety and personnel protection by ensuring that all compounding processes for sterile HDs are performed under the guidelines set forth by USP standards.