FREE NAPLEX QBANK Sterile and Non-sterile Compounding Questions and Answers

Question 1

A pharmacist is compounding a non-sterile, water-containing oral suspension without any stability information.
According to USP , what is the maximum beyond-use date (BUD) that can be assigned to this formulation when stored at controlled cold temperatures?

Accepted Answer

14 days

Answer

6 months

Answer

30 days

Answer

35 days

Question 2

According to USP <797>, the primary engineering control (PEC), such as a laminar airflow workbench or biological safety cabinet, must maintain which minimum ISO Class air quality in the direct compounding area?

Accepted Answer

ISO Class 5

Answer

ISO Class 8

Answer

ISO Class 7

Answer

ISO Class 6

Question 3

A technician is preparing to compound an IV infusion of cyclophosphamide, a hazardous drug. According to USP <800> guidelines, which of the following personal protective equipment (PPE) is required for this task?

Accepted Answer

Two pairs of chemotherapy-rated gloves and a disposable, impermeable gown.

Answer

A single pair of non-sterile gloves and a cloth lab coat.

Answer

An N95 respirator and a single pair of chemotherapy gloves.

Answer

A surgical mask and a reusable gown.

Question 4

A pharmacist needs to incorporate a very small amount of a potent powdered drug into a large amount of diluent to prepare a capsule formulation. Which of the following compounding techniques is most appropriate to ensure a homogenous mixture?

Accepted Answer

Geometric dilution

Answer

Levigation

Answer

Pulverization by intervention

Answer

Spatulation

Question 5

A nurse in an emergency department needs to urgently prepare a single dose of an IV medication for a patient. The process involves a simple transfer from a sterile vial to a syringe. The drug is not hazardous, involves no more than three sterile products, and administration will begin within four hours. Under which USP <797> classification can this preparation be compounded outside of an ISO Class 5 environment?

Accepted Answer

Immediate-Use CSP

Answer

Low-Risk CSP

Answer

Medium-Risk CSP

Answer

High-Risk CSP

Question 6

Which of the following describes the correct order of garbing procedures for a pharmacist entering a sterile compounding cleanroom suite, according to general USP <797> principles?

Accepted Answer

Don shoe covers, head/hair covers, and mask; perform hand hygiene; don gown; apply hand sanitizer; don sterile gloves.

Answer

Don sterile gloves, perform hand hygiene, don gown, then don shoe and hair covers.

Answer

Perform hand hygiene, don gown, don shoe and hair covers, then don sterile gloves.

Answer

Don gown, don sterile gloves, perform hand hygiene, then don shoe and hair covers.