CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 1

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

USP <797> assigns Category 1 CSPs a BUD of 12 hours or less at controlled room temperature.

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

Category 2 CSPs require sterility testing per USP <71> to receive extended BUDs beyond Category 1 limits.

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

Without supporting stability data, Category 2 aqueous CSPs stored at room temperature have a maximum BUD of 45 days.

Question 4

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

Accepted Answer

Elevated storage temperature

Answer

Higher storage temperatures accelerate chemical degradation and microbial growth, directly shortening the BUD.

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

When a commercial sterile product is used as an ingredient, the CSP's BUD cannot exceed the BUD of that ingredient.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 1