For Category 2 w/ No sterility testing results + sterile components, what is the BUD at refrigerator?

For Category 2 w/ No sterility testing results + sterile components, what is the BUD at refrigerator?

• A. 4 days
• B. 1 day
• C. 10 days
• D. 90 days

Answer: (A)

The key idea is that the beyond-use date for a compounded sterile product depends on the risk level and whether sterility testing has been completed. When you have sterile components but no sterility test results, you must apply the most conservative date allowed for that situation. Under refrigeration (2-8°C), that conservative BUD is four days, because the absence of sterility verification means you can’t rely on a longer, validated shelf life. The other options would require a different testing status or storage conditions that aren’t present here, so they don’t fit this scenario.

The key idea is that the beyond-use date for a compounded sterile product depends on the risk level and whether sterility testing has been completed. When you have sterile components but no sterility test results, you must apply the most conservative date allowed for that situation. Under refrigeration (2-8°C), that conservative BUD is four days, because the absence of sterility verification means you can’t rely on a longer, validated shelf life. The other options would require a different testing status or storage conditions that aren’t present here, so they don’t fit this scenario.