Can NIOSH listed HDs be compounded in a positive pressure Controlled Environment for Compounding (C-SEC)?

Compounding hazardous drugs (HDs) listed by NIOSH in a positive pressure environment is considered permissible under certain conditions, specifically when a risk assessment is conducted. This risk assessment is crucial because it evaluates the potential exposure and determines the appropriate controls needed to ensure safety for both the compounding environment and personnel.

In instances where the risk assessment indicates that measures can be put in place to mitigate exposure risks effectively, it may be possible to compound certain hazardous drugs in a positive pressure Controlled Environment for Compounding (C-SEC). This approach allows for flexibility in the compounding process while ensuring that the safety and efficacy of the compounding environment are not compromised.

This answer aligns with the guidelines outlined in USP <800>, which emphasizes the importance of risk assessment in determining the most appropriate compounding environment for hazardous drugs, including considerations for both positive and negative pressure settings.