Free NAPLEX QBANK Sterile and Non-sterile Compounding Questions and Answers 1 — 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?
- 6 months
- 30 days
- 14 days (Correct answer)
- 35 days
Correct answer: 14 days
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?
- ISO Class 8
- ISO Class 7
- ISO Class 6
- ISO Class 5 (Correct answer)
Correct answer: ISO Class 5
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?
- A single pair of non-sterile gloves and a cloth lab coat.
- An N95 respirator and a single pair of chemotherapy gloves.
- Two pairs of chemotherapy-rated gloves and a disposable, impermeable gown. (Correct answer)
- A surgical mask and a reusable gown.
Correct answer: Two pairs of chemotherapy-rated gloves and a disposable, impermeable gown.
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?
- Levigation
- Geometric dilution (Correct answer)
- Pulverization by intervention
- Spatulation
Correct answer: Geometric dilution
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?
- Low-Risk CSP
- Medium-Risk CSP
- High-Risk CSP
- Immediate-Use CSP (Correct answer)
Correct answer: Immediate-Use CSP
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.
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?
- Don sterile gloves, perform hand hygiene, don gown, then don shoe and hair covers.
- Perform hand hygiene, don gown, don shoe and hair covers, then don sterile gloves.
- Don shoe covers, head/hair covers, and mask; perform hand hygiene; don gown; apply hand sanitizer; don sterile gloves. (Correct answer)
- Don gown, don sterile gloves, perform hand hygiene, then don shoe and hair covers.
Correct answer: Don shoe covers, head/hair covers, and mask; perform hand hygiene; don gown; apply hand sanitizer; don sterile gloves.
USP <797> requires a specific garbing sequence to minimize contamination, proceeding from dirtiest to cleanest activities. Personnel first don shoe covers, head/hair covers, and a face mask in the ante-area. This is followed by hand hygiene. A non-shedding gown is donned next. Upon entering the buffer area, an alcohol-based hand rub is used before donning sterile gloves as the final step before compounding.
Free NAPLEX QBANK Sterile and Non-sterile Compounding Questions and Answers 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?