Which USP chapter covers standards for sterile compounding?

Which USP chapter covers standards for sterile compounding?

• A. USP 795
• B. USP 797
• C. USP 800
• D. USP 780

Answer: (B)

The key idea is understanding where sterile products are governed. Sterile compounding requires strict controls to prevent contamination, and the standards for this are laid out in the USP chapter dedicated to sterile drug preparation. It covers the environment (cleanroom design and ISO classifications), engineering controls, garbing and aseptic technique, environmental monitoring, cleaning and disinfection, personnel training and competency, and documentation, including beyond-use dating for sterile products. By following these requirements, pharmacies ensure that injections, IV admixtures, ophthalmic, and other sterile products are safe for patients. Other USP chapters address different areas, such as nonsterile compounding or handling hazardous drugs, which do not cover the standards for sterile preparation. Therefore, the chapter that explicitly covers sterile compounding standards is the one focused on sterile drug products.

The key idea is understanding where sterile products are governed. Sterile compounding requires strict controls to prevent contamination, and the standards for this are laid out in the USP chapter dedicated to sterile drug preparation. It covers the environment (cleanroom design and ISO classifications), engineering controls, garbing and aseptic technique, environmental monitoring, cleaning and disinfection, personnel training and competency, and documentation, including beyond-use dating for sterile products. By following these requirements, pharmacies ensure that injections, IV admixtures, ophthalmic, and other sterile products are safe for patients.

Other USP chapters address different areas, such as nonsterile compounding or handling hazardous drugs, which do not cover the standards for sterile preparation. Therefore, the chapter that explicitly covers sterile compounding standards is the one focused on sterile drug products.