Pharmacy Pharmacy Sterile Compounding

Question 1

Which USP chapter provides the standards for sterile compounding in US pharmacies?

Accepted Answer

USP <797>

Answer

USP <795>

Answer

USP <800>

Answer

USP <71>

Question 2

What is the purpose of an ISO Class 5 primary engineering control (PEC) in sterile compounding?

Accepted Answer

To provide an ultra-low particle environment for manipulating sterile products

Answer

To decontaminate hazardous drug waste

Answer

To store refrigerated CSPs

Answer

To perform sterility testing of finished preparations

Question 3

What is the correct technique for cleaning a laminar airflow workbench (LAFW) before sterile compounding?

Accepted Answer

Wipe from back to front and side to side using sterile 70% IPA

Answer

Wipe from front to back using tap water then 70% IPA

Answer

Spray the entire surface with bleach and allow to dry

Answer

Wipe in circular motions with non-sterile isopropyl alcohol

Question 4

Which beyond-use date (BUD) category applies to a Category 1 CSP stored at room temperature under USP <797>?

Accepted Answer

12 hours

Answer

24 hours

Answer

30 days

Answer

14 days

Question 5

What does 'aseptic technique' mean in sterile compounding?

Accepted Answer

A set of practices that prevent microbial contamination during product preparation

Answer

Sterilizing equipment using an autoclave

Answer

Verifying the sterility of finished products by culture

Answer

Filtering CSPs through a 0.22-micron membrane

Question 6

Which hand hygiene procedure is required before entering a cleanroom for sterile compounding?

Accepted Answer

Perform a surgical hand scrub with soap and water followed by application of sterile gloves

Answer

Use alcohol-based hand sanitizer only

Answer

Wash hands briefly with soap then don gloves immediately

Answer

Clean hands with antiseptic wipe and don gloves without rinsing