CPJE CPJE Sterile Products and IV Admixtures 1 — Questions and Answers
Question 1: According to California pharmacy law, who may prepare sterile compounded preparations in a non-hospital pharmacy?
- A licensed pharmacist or a pharmacy technician under pharmacist supervision (Correct answer)
- Any pharmacy employee with training
- Only a pharmacist
- A physician with DEA registration
Correct answer: A licensed pharmacist or a pharmacy technician under pharmacist supervision
California law allows pharmacy technicians to prepare sterile compounds only under the direct supervision of a licensed pharmacist.
Question 2: USP <797> categorizes compounded sterile preparations (CSPs) by risk level. Which factor primarily determines the risk category?
- Sterility assurance level based on preparation method and environment (Correct answer)
- Cost of the preparation
- Number of ingredients combined
- Patient diagnosis
Correct answer: Sterility assurance level based on preparation method and environment
USP <797> assigns risk levels (Category 1 or 2 under 2023 standards) based on the ISO environment, sterilization method, and beyond-use dating.
Question 3: What is the minimum ISO classification required for the Direct Compounding Area (DCA) where sterile products are actually prepared?
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
- ISO Class 3
Correct answer: ISO Class 5
USP <797> requires the direct compounding area (e.g., laminar airflow workbench or biological safety cabinet) to maintain ISO Class 5 air quality.
Question 4: A beyond-use date (BUD) for a Category 1 CSP stored at room temperature is limited to:
- 12 hours (Correct answer)
- 24 hours
- 48 hours
- 7 days
Correct answer: 12 hours
Under USP <797> (2023), Category 1 CSPs not prepared in a cleanroom suite are assigned a maximum BUD of 12 hours at room temperature.
Question 5: What type of laminar airflow workbench (LAFW) is required when compounding cytotoxic sterile preparations?
- Biological safety cabinet (BSC) Class II Type B2 (Correct answer)
- Horizontal LAFW
- Vertical LAFW without containment
- Cleanroom without a hood
Correct answer: Biological safety cabinet (BSC) Class II Type B2
Hazardous drugs like cytotoxics must be prepared in a Class II Type B2 BSC to protect both the product and the compounder from exposure.
Question 6: Which garbing element is donned LAST when entering a cleanroom for sterile compounding?
- Sterile gloves (Correct answer)
- Shoe covers
- Hair cover
- Face mask
Correct answer: Sterile gloves
Sterile gloves are the final garbing item to prevent recontamination of gloved hands before compounding begins.
CPJE CPJE Sterile Products and IV Admixtures 1
According to California pharmacy law, who may prepare sterile compounded preparations in a non-hospital pharmacy?