NAPLEX QBANK Sterile and Non-Sterile Compounding Questions and Answers

Question 1

A pharmacist needs to compound an ointment containing 100 mg of a potent corticosteroid powder using 19.9 g of a petrolatum base. To ensure the active ingredient is uniformly distributed, which of the following compounding techniques is most appropriate?

Accepted Answer

Geometric dilution

Answer

Geometric dilution is the process of thoroughly mixing a small amount of a potent drug with a large amount of a diluent. The process involves mixing the smaller quantity of powder (the corticosteroid) with an approximately equal quantity of the diluent (petrolatum base). This mixture is then combined with an equal portion of the diluent, and the process is repeated until all the diluent is incorporated. This ensures the final product is homogeneous.

Question 2

According to USP Chapter <797>, which of the following represents the correct sequence for donning personal protective equipment (PPE) before entering the buffer area for sterile compounding?

Accepted Answer

Don shoe covers and hair cover, wash hands, don gown, apply alcohol-based hand scrub, don sterile gloves.

Answer

USP <797> outlines a specific garbing procedure to minimize contamination, moving from dirtiest to cleanest activities. Personnel should first don shoe covers, head/facial hair covers, and face masks. Following this, they must perform hand hygiene. After hand washing, a non-shedding gown is donned. An alcohol-based surgical hand scrub should be used before entering the buffer area. Sterile gloves are the last item to be donned, typically inside the buffer room just before compounding.

Question 3

A batch of parenteral nutrition (PN) solutions is prepared in an ISO 5 primary engineering control located within an ISO 7 buffer room. The compounding involves multiple additions and manipulations. According to the revised USP <797> guidelines, what is the maximum beyond-use date (BUD) for this Compounded Sterile Product (CSP) if it is stored in a refrigerator?

Accepted Answer

9 days

Answer

The revised USP <797> categorizes CSPs based on the environment in which they are compounded rather than by low, medium, or high risk. A CSP prepared in an ISO 5 PEC within an ISO 7 buffer room is considered a Category 2 CSP. For aseptically processed Category 2 CSPs without sterility testing, the maximum BUD when stored under refrigeration (2°C to 8°C) is 9 days, assuming stability data supports it.

Question 4

A pharmacist is preparing a powdered formulation and needs to reduce the particle size of a coarse, crystalline substance to create a fine, uniform powder. Which non-sterile compounding technique best describes this process?

Accepted Answer

Trituration

Answer

Trituration is the process of rubbing, grinding, or pulverizing a powder to reduce its particle size. This is typically done in a mortar with a pestle. Levigation involves reducing particle size by triturating it in a mortar or on an ointment slab with a small amount of a liquid in which the solid is not soluble. Spatulation is the blending of powders with a spatula, and eutectic mixing refers to the liquefaction of two solids when mixed together.

Question 5

Which of the following correctly describes the air pressure relationship required by USP <797> for a non-hazardous sterile compounding cleanroom suite?

Accepted Answer

The buffer area must be at a positive pressure to the anteroom, and the anteroom must be at a positive pressure to the general pharmacy area.

Answer

To prevent the influx of lower-quality air, USP <797> requires a positive pressure cascade for non-hazardous compounding. The buffer area (the cleanest room, typically ISO 7) must maintain a positive pressure relative to the adjacent anteroom (typically ISO 8). The anteroom, in turn, must maintain a positive pressure relative to the unclassified general pharmacy area. This ensures that air flows from cleaner spaces to less clean spaces, reducing the risk of contamination.

NAPLEX QBANK Practice Test

NAPLEX QBANK Practice Test

NAPLEX QBANK Sterile and Non-Sterile Compounding Questions and Answers