Which category does a CSP fall into if its BUD may be greater than 12 hours at controlled room temperature?

A compounding sterile preparation (CSP) that has a beyond-use date (BUD) greater than 12 hours at controlled room temperature falls into Category 2. This classification is established by the regulatory guidelines for sterile compounding.

Category 2 CSPs are intended for use when products are compounded from sterile ingredients and the BUD is significantly longer—between 12 hours and 30 days—depending on the specifics of the compounding process and storage conditions. Typically, Category 2 preparations must be made in a cleanroom environment and adhere to strict aseptic techniques to minimize contamination risks, which justifies the extended BUD. These guidelines ensure that the compounded preparations maintain their quality and effectiveness over a defined time frame under specific conditions.

In contrast, other categories would have differing BUDs. For example, Category 1 typically refers to preparations that must be used immediately or have very short BUDs, and Category 3 or Category 4 would usually apply to different standards that either denote shorter BUDs or other specific compounding environments. Understanding these classifications is essential for ensuring safe and effective sterile compounding practices.