In sterile compounding, which topic is primarily governed by USP <797>?

• A. Sterile compounding.
• B. Hazardous drug handling.
• C. Non-sterile compounding.
• D. Medication reconciliation.

Answer: (A)

USP <797> sets the standards for sterile preparation. It defines how sterile medications must be produced, covering the cleanroom environment, aseptic technique, garbing, validation of sterile procedures, personnel training, cleaning, environmental monitoring, beyond-use dating, labeling, and ongoing quality assurance to protect patients from contamination. In the context of sterile compounding, this is the primary authority guiding how these products are prepared and controlled. Other topics are governed by different standards: hazardous drug handling is addressed by USP <800>, non-sterile compounding by USP <795>, and medication reconciliation is a broader patient-safety process not dictated by USP <797>.