CPJE CPJE Sterile Products and IV Admixtures

Question 1

According to California pharmacy law, who may prepare sterile compounded preparations in a non-hospital pharmacy?

Accepted Answer

A licensed pharmacist or a pharmacy technician under pharmacist supervision

Answer

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?

Accepted Answer

Sterility assurance level based on preparation method and environment

Answer

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?

Accepted Answer

ISO Class 5

Answer

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:

Accepted Answer

12 hours

Answer

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?

Accepted Answer

Biological safety cabinet (BSC) Class II Type B2

Answer

Hazardous drugs like cytotoxics must be prepared in a Class II Type B2 BSC to protect both the product and the compounder from exposure.

CPJE - California Pharmacy Jurisprudence Exam Practice Test