What are the three categories of compounded sterile preparations (CSPs) defined by USP 797?

The correct answer identifies the categories of compounded sterile preparations (CSPs) as Category 1, Category 2, and Category 3, which align with the classifications established by USP 797. These categories are essential as they help determine the risk level associated with various types of sterile compounding practices.

Category 1 CSPs are those that are prepared from non-sterile ingredients or using non-sterile equipment. These preparations are generally perceived to have a higher risk of contamination because they may not meet the standards of sterility at the time of preparation.

Category 2 CSPs, on the other hand, are those that are prepared in a controlled environment and are typically considered to have a lower risk of contamination due to more stringent practices and procedures followed during preparation.

Category 3 encompasses CSPs that are prepared under the most rigorous aseptic conditions, with a focus on maintaining sterility throughout the preparation and dispensing process.

These classifications are crucial for healthcare professionals to understand as they play a significant role in dictating the sterility requirements, testing, and storage of the compounded preparations. This categorization helps maintain patient safety and efficacy of the compounded medications.