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

Any pharmacy employee with training

Answer

Only a pharmacist

Answer

A physician with DEA registration

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

Cost of the preparation

Answer

Number of ingredients combined

Answer

Patient diagnosis

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

ISO Class 7

Answer

ISO Class 8

Answer

ISO Class 3

Question 4

A beyond-use date (BUD) for a Category 1 CSP stored at room temperature is limited to:

Accepted Answer

12 hours

Answer

24 hours

Answer

48 hours

Answer

7 days

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

Horizontal LAFW

Answer

Vertical LAFW without containment

Answer

Cleanroom without a hood

Question 6

Which garbing element is donned LAST when entering a cleanroom for sterile compounding?

Accepted Answer

Sterile gloves

Answer

Shoe covers

Answer

Hair cover

Answer

Face mask