During nonsterile compounding with hazardous active pharmaceutical ingredients (APIs), where must compounding steps occur?

Compounding steps involving hazardous active pharmaceutical ingredients (APIs) must occur in the Compounding Aseptic Primary Engineering Control (C-PEC) because this environment is specifically designed to provide a controlled atmosphere that protects both the worker and the environment from contamination. The C-PEC is equipped to maintain appropriate environmental conditions, including air quality and flow patterns, to reduce the risk of exposure to hazardous substances and to ensure that the compounded preparations are sterile and safe for administration.

In essence, the design and function of the C-PEC ensure that hazardous substances are handled in a manner that minimizes the risk of exposure and contamination. This includes features like appropriate airflow, filtering systems, and containment practices that are critical in managing the risks associated with hazardous compounding. Nonsterile compounding with hazardous APIs requires such stringent controls to ensure safety and compliance with regulatory requirements.

Other areas, such as the main laboratory or just any clean space, do not offer the specific protections needed for handling hazardous materials, which necessitates using a C-PEC for compliance with USP 800 regulations.