CPJE Sterile Products and IV Admixtures Flashcards
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According to California pharmacy law, who may prepare sterile compounded preparations in a non-hospital pharmacy?
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.
USP categorizes compounded sterile preparations (CSPs) by risk level. Which factor primarily determines the risk category?
Answer: Sterility assurance level based on preparation method and environment
USP assigns risk levels (Category 1 or 2 under 2023 standards) based on the ISO environment, sterilization method, and beyond-use dating.
What is the minimum ISO classification required for the Direct Compounding Area (DCA) where sterile products are actually prepared?
Answer: ISO Class 5
USP requires the direct compounding area (e.g., laminar airflow workbench or biological safety cabinet) to maintain ISO Class 5 air quality.
A beyond-use date (BUD) for a Category 1 CSP stored at room temperature is limited to:
Answer: 12 hours
Under USP (2023), Category 1 CSPs not prepared in a cleanroom suite are assigned a maximum BUD of 12 hours at room temperature.
What type of laminar airflow workbench (LAFW) is required when compounding cytotoxic sterile preparations?
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.
Which garbing element is donned LAST when entering a cleanroom for sterile compounding?
Answer: Sterile gloves
Sterile gloves are the final garbing item to prevent recontamination of gloved hands before compounding begins.