In which situation must a Category 2 CSP be prepared?

The preparation of a Category 2 Compounded Sterile Preparation (CSP) is required in situations where there is a scheduled preparation that could pose a risk of contamination without the proper sterile conditions. This category includes CSPs that are complex, such as those that require multi-step processes or lengthy preparation times. Given the nature of such preparations, they must be completed under stringent sterility controls to mitigate the risk of microbial contamination and ensure patient safety.

The emphasis on scheduled preparations indicates that these CSPs typically are not made immediately for administration but are instead made in advance. This means that they need to be carried out in a controlled environment, such as a cleanroom or hood using aseptic techniques, to ensure compliance with safety and sterility standards. The rationale behind this requirement is to maintain the integrity of the product until administration and to prevent any potential health risks to patients.

In contrast, situations involving quick preparations without significant risk, immediate patient use, or outpatient settings do not necessarily fit the criteria for Category 2 CSPs, as these scenarios may not involve the same level of risk or complexity requiring stringent sterilization protocols.