Which chapter of the USP outlines requirements for sterile compounding?

The correct answer is General Chapter 797. This chapter of the United States Pharmacopeia (USP) specifically addresses sterile compounding practices. It provides guidelines essential for ensuring the safety, quality, and integrity of compounded sterile preparations (CSPs). The chapter outlines the necessary conditions under which sterile products must be prepared, including standards for cleanliness, equipment, materials, and personnel involved in the compounding process.

General Chapter 797 emphasizes key components such as the proper use of aseptic techniques, environmental controls (such as the use of laminar flow hoods), and the importance of staff training and competency evaluation. These standards are vital for minimizing risks such as contamination, which could lead to serious patient harm.

In contrast, General Chapter 800 focuses on handling hazardous drugs and the precautions necessary to protect both healthcare workers and patients from potentially dangerous agents. General Chapter 1000 and General Chapter 300 are related to overall compounding and specific practices, respectively, but they do not address sterile compounding directly like Chapter 797 does.