PTCB Certified Pharmacy Technician (PTCE)Order Entry and ProcessingHard
A pharmacy technician is checking the expiration dates of medications. According to USP <797> guidelines, what is the beyond-use date (BUD) for a sterile compounded preparation prepared in a ISO Class 5 laminar airflow workbench from sterile ingredients, intended for administration within 24 hours (room temperature)?
- A12 hours
- B7 days
- C1 hour
- D24 hours
Show answer & explanationAnswer & explanation
Correct answer: A. 12 hours
According to USP <797> guidelines for compounded sterile preparations (CSPs) made from sterile ingredients in an ISO Class 5 environment, a low-risk CSP with a room temperature storage condition has a BUD of 12 hours if it is administered within that timeframe. The low-risk with short BUD category specifically addresses this scenario.
Why the other options are wrong
- B. This is for low-risk CSPs stored under refrigeration, not room temperature.
- C. Too short for this scenario; 1 hour is for immediate use preparations.
- D. This might be confused with the administration timeframe, but the BUD is 12 hours for this category.
USP <797> Beyond-Use Date (BUD) Categories
Guidelines for assigning appropriate BUDs to compounded sterile preparations (CSPs) based on the risk level of contamination, storage conditions, and whether sterile or non-sterile ingredients are used.
- Risk levels: Low, Medium, High.
- BUDs vary by risk level and storage temperature.
- Low-risk with short BUD category exists for specific scenarios.
Memory trick: Sterile BUDs: Risk, Room, Refrigerator – Know Your Limits!