CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers

Question 1

According to USP <797>, what is the maximum beyond-use date (BUD) for a Category 1 compounded sterile preparation (CSP) stored at room temperature?

Accepted Answer

12 hours

Answer

24 hours

Answer

48 hours

Answer

72 hours

Question 2

Which condition must be met for a CSP to qualify for Category 2 beyond-use dating under USP <797>?

Accepted Answer

Sterility testing performed per USP <71>

Answer

Prepared in an ISO 7 environment only

Answer

Used within 24 hours of preparation

Answer

Prepared without any antimicrobial preservatives

Question 3

When no stability data is available, USP <797> limits the BUD of a Category 2 aqueous CSP stored at controlled room temperature to a maximum of how many days?

Accepted Answer

45 days

Answer

14 days

Answer

30 days

Answer

60 days

Question 4

Which factor most directly shortens the assigned BUD of a compounded sterile preparation?

Accepted Answer

Elevated storage temperature

Answer

Use of a laminar airflow workbench

Answer

Preparation by a pharmacist

Answer

Use of amber vials

Question 5

A CSP is prepared using a commercial sterile ingredient. Under USP <797>, the BUD of the final preparation may not exceed:

Accepted Answer

The BUD of the commercial product used

Answer

30 days regardless of ingredients

Answer

The date determined by sterility testing

Answer

90 days if refrigerated

Question 6

Which USP chapter governs sterility testing used to support extended beyond-use dates for Category 2 CSPs?

Accepted Answer

<71>

Answer

USP <1>

Answer

<51>

Answer

<85>