For Category 2 CSPs that are Aseptically Prepared with No sterility testing results and at least one nonsterile component, what is the BUD at controlled room temperature?

For Category 2 CSPs that are Aseptically Prepared with No sterility testing results and at least one nonsterile component, what is the BUD at controlled room temperature?

• A. 4 days
• B. 1 day
• C. 60 days
• D. 90 days

Answer: (B)

The key idea here is sterility assurance driving the beyond-use date. When a CSP is aseptically prepared and includes at least one nonsterile component, and there are no sterility test results to confirm the product’s sterility, you cannot rely on any evidence of sterility. In that situation the safest, most conservative choice for storage at controlled room temperature is one day. The lack of sterility testing means there’s uncertainty about contamination; keeping the product for longer at room temperature could allow growth if any microorganisms are present. If sterility testing had been done and shown negative for contamination, or if all components were sterile and the preparation followed validated sterile techniques, a longer BUD might be justified. The longer options aren’t appropriate here because they assume sterility assurance that isn’t present.

The key idea here is sterility assurance driving the beyond-use date. When a CSP is aseptically prepared and includes at least one nonsterile component, and there are no sterility test results to confirm the product’s sterility, you cannot rely on any evidence of sterility. In that situation the safest, most conservative choice for storage at controlled room temperature is one day. The lack of sterility testing means there’s uncertainty about contamination; keeping the product for longer at room temperature could allow growth if any microorganisms are present. If sterility testing had been done and shown negative for contamination, or if all components were sterile and the preparation followed validated sterile techniques, a longer BUD might be justified. The longer options aren’t appropriate here because they assume sterility assurance that isn’t present.