Does USP 800 require environmental sampling in every area where hazardous drugs are handled?

The correct answer is that the United States Pharmacopeia (USP) 800 does not mandate environmental sampling in every area where hazardous drugs are handled; rather, it recommends this practice but does not require it. The rationale behind this is that while environmental monitoring is a critical component of ensuring a safe handling environment for hazardous drugs, the regulations aim to balance safety with practicality and resource allocation.

Therefore, facilities must perform risk assessments to determine when and where environmental sampling is necessary. This means that while it's advisable to conduct sampling to identify potential contamination in areas where hazardous drugs are handled, particularly in high-risk areas, it is not an absolute requirement for all settings. This flexibility allows healthcare facilities to tailor their environmental monitoring practices based on their specific operations, the types of hazardous drugs handled, and potential exposure risks.

This approach also aligns with the overall intent of USP 800, which emphasizes safe handling practices and risk mitigation without imposing an overly burdensome regulatory framework. Thus, while the importance of contamination control is acknowledged, the requirement for sampling is not universally applied across all handling areas.