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 <795>, 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

According to USP General Chapter <795>, the default beyond-use date for a water-containing oral formulation, in the absence of stability information, is not later than 14 days when stored at controlled cold temperatures. Options for 30 days are for water-containing topical/dermal formulations, 35 days for preserved aqueous formulations, and 6 months (180 days) for nonaqueous formulations.

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

USP <797> requires that the direct compounding area within a primary engineering control (PEC) must maintain ISO Class 5 air quality to protect critical sites from contamination. ISO Class 7 is the standard for the buffer area, and ISO Class 8 is the standard for the ante-area.

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

USP <800> mandates specific PPE for handling hazardous drugs to minimize exposure. This includes wearing two pairs of chemotherapy gloves that meet ASTM D6978 standards and a disposable gown that is impermeable to hazardous drugs and closes in the back. Single pairs of gloves, cloth coats, or standard surgical masks do not provide adequate protection. While respiratory protection may be needed, it is part of a larger set of required PPE.

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

Geometric dilution is the standard method for blending two or more powder ingredients of unequal quantities to ensure the final mixture is uniform. It involves starting with the smallest quantity ingredient and mixing it with an approximately equal amount of the larger quantity ingredient, then continuing to add the diluent in amounts equal to the mixture's volume until all the diluent is incorporated.

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

This scenario meets the criteria for an Immediate-Use Compounded Sterile Preparation (CSP). According to USP <797>, immediate-use CSPs are exempt from the requirements for Category 1, 2, or 3 CSPs (and the older low/medium/high risk levels) if they are intended for emergency or immediate patient administration, involve no more than three sterile products, and administration begins within four hours of the start of preparation. Low, Medium, and High-Risk CSPs require preparation within an ISO Class 5 PEC.

NAPLEX QBANK Practice Test

NAPLEX QBANK Practice Test

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