For Category 2 w/ Passed sterility testing, what is the BUD at freezer?

For Category 2 w/ Passed sterility testing, what is the BUD at freezer?

• A. 60 days
• B. 30 days
• C. 90 days
• D. 120 days

Answer: (A)

Beyond-use dating for sterile preparations depends on the risk category and storage temperature. For Category 2 products that have undergone and passed sterility testing, the BUD when stored in the freezer is 60 days. The sterility testing provides evidence that the product stays sterile for that period, and freezing helps preserve it, giving a two-month window. Shorter dates like 30 days apply to other scenarios without sterility testing or at non-freezer temperatures, while longer dates aren’t supported for this category under these storage conditions.

Beyond-use dating for sterile preparations depends on the risk category and storage temperature. For Category 2 products that have undergone and passed sterility testing, the BUD when stored in the freezer is 60 days. The sterility testing provides evidence that the product stays sterile for that period, and freezing helps preserve it, giving a two-month window. Shorter dates like 30 days apply to other scenarios without sterility testing or at non-freezer temperatures, while longer dates aren’t supported for this category under these storage conditions.