Category 2 BUD: Terminal Sterilized w/ No sterility testing results; durations: 14 days RT; 28 days fridge; 45 days freezer. Which is correct?

Category 2 BUD: Terminal Sterilized w/ No sterility testing results; durations: 14 days RT; 28 days fridge; 45 days freezer. Which is correct?

• A. 14 days RT; 28 days fridge; 45 days freezer
• B. 7 days RT; 14 days fridge; 21 days freezer
• C. 3 days RT; 7 days fridge; 14 days freezer
• D. 14 days RT; 28 days fridge; 60 days freezer

Answer: (A)

Beyond-use dating for compounded sterile products sets specific time limits based on how the product was prepared and what data are available. When a product is terminally sterilized but there are no sterility testing results to confirm continued sterility, the guidance assigns what’s called a Category 2 BUD: 14 days at room temperature, 28 days in the refrigerator, and 45 days in the freezer. The idea is that sterilization provides initial sterility, but without test data to confirm ongoing sterility, the allowed storage times must remain conservative, with the cold temperatures extending the BUD but not exceeding those listed limits. So the correct schedule is 14 days at room temperature, 28 days refrigerated, and 45 days frozen.

Beyond-use dating for compounded sterile products sets specific time limits based on how the product was prepared and what data are available. When a product is terminally sterilized but there are no sterility testing results to confirm continued sterility, the guidance assigns what’s called a Category 2 BUD: 14 days at room temperature, 28 days in the refrigerator, and 45 days in the freezer. The idea is that sterilization provides initial sterility, but without test data to confirm ongoing sterility, the allowed storage times must remain conservative, with the cold temperatures extending the BUD but not exceeding those listed limits. So the correct schedule is 14 days at room temperature, 28 days refrigerated, and 45 days frozen.