Which USP chapters govern sterile compounding and hazardous drug handling, and why are they relevant to safety?

• A. USP <797> for sterile compounding and USP <800> for hazardous drugs.
• B. USP <795> and USP <800>.
• C. USP <797> for hazardous drugs and USP <800> for sterile compounding.
• D. USP <825> and USP <825>.

Answer: (A)

The main idea is that safety for both how sterile products are made and how hazardous drugs are handled is governed by specific USP chapters. USP <797> sets the standards for sterile compounding, covering everything from facility design and air quality to aseptic technique, garbing, and cleanroom practices, as well as how to validate sterility and determine beyond-use dating. These guidelines are essential to prevent contamination and ensure that every sterile preparation given to patients is safe and effective.

USP <800> focuses on the safe handling of hazardous drugs to protect healthcare workers and the environment. It outlines risk assessment, engineering controls (like appropriate containment devices and ventilation), personal protective equipment, procedures for contamination control, deactivation and disinfection, storage and waste management, and training. Together, these chapters address both patient safety in sterile preparations and worker safety when dealing with hazardous agents.

Other options mix topics that don’t align with both sterile compounding and hazardous drug handling, such as non-sterile compounding standards or radiopharmaceutical-specific guidance, so they don’t correctly capture the required safety framework.