What is classified as 'high-risk' CSP?

The classification of 'high-risk' compounded sterile preparations (CSPs) specifically refers to those preparations that are made under conditions that do not adequately ensure sterility. This includes situations where non-sterile ingredients are used or where the compounding environment does not demonstrate evidence of clean conditions. Such factors significantly increase the potential for contamination, making these CSPs at a higher risk for causing infections or other complications when administered to patients.

For example, non-sterile ingredients can introduce bacteria, fungi, or other pathogens, while a facility lacking an appropriate sterile compounding environment may lead to airborne contaminants affecting the final product. Therefore, the classification as 'high-risk' is fundamentally about ensuring patient safety by minimizing the risk of introducing harmful microorganisms during the compounding process.

The other options pertain to CSPs that are either prepared in controlled environments or with sterile ingredients, which generally fall under lower risk categories as they have stricter controls and protocols in place to ensure their sterility and safety.