What do the categories "low, medium, and high-risk" signify in the context of USP 797?

The categories of "low, medium, and high-risk" in the context of USP 797 pertain specifically to the levels of microbial contamination risk associated with the compounding of sterile preparations. Understanding these risk levels is crucial for pharmacists and healthcare professionals involved in sterile compounding, as they guide the necessary safety measures and practices that must be implemented to minimize the risk of contamination and ensure patient safety.

Low-risk compounding involves minimal manipulation of sterile products, typically using closed systems and following strict aseptic techniques, which results in a very low chance of introducing contaminants. Medium-risk compounding involves more complex procedures, such as mixing multiple ingredients or preparing batch compounds, which increases the potential for contamination if not handled properly. High-risk compounding involves processes that pose the greatest risk of contamination, such as using non-sterile ingredients or environments that may not be appropriately controlled for sterility.

These distinctions directly inform the practices and protocols required for compounding sterile preparations, including environmental controls, personnel training, and quality assurance measures to protect patients from potential harm. Understanding these risk categories ensures that compounding professionals comply with the standards set forth by USP 797, which is essential for maintaining the integrity and safety of compounded sterile products.