For Category 3 CSPs that are Aspetically prepared + Sterility tested + Passed all applicable tests, what is the BUD at refrigerator temperature?

For Category 3 CSPs that are Aspetically prepared + Sterility tested + Passed all applicable tests, what is the BUD at refrigerator temperature?

• A. 120 days
• B. 60 days
• C. 90 days
• D. 180 days

Answer: (C)

BUD is determined by how the CSP is prepared and whether sterility testing has been completed and passed. When a Category 3 CSP is aseptically prepared and then sterility tested with successful results, the ability to demonstrate sterility allows a longer refrigerated shelf life. Therefore, at 2–8°C, the recommended BUD is 90 days, meaning you should use the product within three months of compounding. This reflects the extra assurance provided by confirming sterility, compared to CSPs that have not undergone sterility testing (which would have a shorter BUD). If stored at room temperature, the BUD would be different and is not applicable here.

BUD is determined by how the CSP is prepared and whether sterility testing has been completed and passed. When a Category 3 CSP is aseptically prepared and then sterility tested with successful results, the ability to demonstrate sterility allows a longer refrigerated shelf life. Therefore, at 2–8°C, the recommended BUD is 90 days, meaning you should use the product within three months of compounding. This reflects the extra assurance provided by confirming sterility, compared to CSPs that have not undergone sterility testing (which would have a shorter BUD). If stored at room temperature, the BUD would be different and is not applicable here.