CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 1 — 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?
- 12 hours (Correct answer)
- 24 hours
- 48 hours
- 72 hours
Correct answer: 12 hours
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>?
- Prepared in an ISO 7 environment only
- Sterility testing performed per USP <71> (Correct answer)
- Used within 24 hours of preparation
- Prepared without any antimicrobial preservatives
Correct answer: Sterility testing performed per USP <71>
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?
- 14 days
- 30 days
- 45 days (Correct answer)
- 60 days
Correct answer: 45 days
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?
- Use of a laminar airflow workbench
- Elevated storage temperature (Correct answer)
- Preparation by a pharmacist
- Use of amber vials
Correct answer: Elevated storage temperature
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:
- The BUD of the commercial product used (Correct answer)
- 30 days regardless of ingredients
- The date determined by sterility testing
- 90 days if refrigerated
Correct answer: The BUD of the commercial product used
When a commercial sterile product is used as an ingredient, the CSP's BUD cannot exceed the BUD of that ingredient.
Question 6: Which USP chapter governs sterility testing used to support extended beyond-use dates for Category 2 CSPs?
- USP <1>
- <51>
- <71> (Correct answer)
- <85>
Correct answer: <71>
USP <71> Sterility Tests is the compendial standard used to validate sterility of Category 2 CSPs.
CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 1
According to USP , what is the maximum beyond-use date (BUD) for a Category 1 compounded sterile preparation (CSP) stored at room temperature?