What is the risk level associated with compounding that involves non-sterile ingredients?

Compounding that involves non-sterile ingredients is classified as a high risk level according to USP 797 standards. This classification is due to the potential for contamination when integrating non-sterile ingredients in the compounding process. The use of these ingredients increases the risk of exposing patients to harmful microorganisms, especially when these compounded preparations are intended for parenteral administration.

High risk level compounding typically involves conditions where sterile products are exposed to environments that do not meet sterile conditions, or where the compounders fail to follow appropriate hygienic and aseptic techniques. This necessitates a more rigorous approach to sterility testing and environmental monitoring to ensure patient safety.

In contrast, low and moderate risk levels typically involve the use of sterile ingredients or the manipulation of sterile products under more controlled conditions, which inherently carries a lower risk of contamination. No risk level is not applicable in the context of compounding, as all compounding activities carry a certain level of risk that must be evaluated and mitigated. Thus, recognizing the correct classification of compounding involving non-sterile ingredients as high risk is crucial for ensuring safety and compliance with USP 797 guidelines.