ExCPT Test Sterile and Non-Sterile Compounding 1 — Questions and Answers
Question 1: Which USP chapter specifically regulates non-sterile compounding practices in pharmacy?
- USP <795> (Correct answer)
- USP <797>
- USP <800>
- USP <825>
Correct answer: USP <795>
USP <795> provides standards for non-sterile compounding, covering areas such as beyond-use dating, stability, and labeling for preparations that do not require sterility.
Question 2: A compounding technician is preparing an IV admixture. Which of the following actions is considered a critical step in maintaining aseptic technique?
- Wiping the vial stopper with a 70% isopropyl alcohol swab before needle entry (Correct answer)
- Using tap water to rinse equipment before compounding
- Compounding near an open window for ventilation
- Wearing a surgical mask only, without gloves
Correct answer: Wiping the vial stopper with a 70% isopropyl alcohol swab before needle entry
Swabbing the vial stopper with 70% isopropyl alcohol before needle entry disinfects the surface and prevents introducing contaminants into the sterile preparation.
Question 3: What does the term 'clean room' refer to in a sterile compounding pharmacy?
- A room with controlled temperature used for refrigerated products
- An environmentally controlled space with defined ISO air quality classifications for sterile preparation (Correct answer)
- Any pharmacy area that has been mopped and sanitized daily
- A designated storage area for compounded preparations
Correct answer: An environmentally controlled space with defined ISO air quality classifications for sterile preparation
A clean room is an ISO-classified, environmentally controlled space designed to minimize airborne particulates and microbial contamination during sterile compounding.
Question 4: When compounding a non-sterile topical cream, which of the following equipment is most commonly used to achieve a uniform mixture?
- Laminar airflow workbench
- Electronic mortar and pestle (or ointment mill) (Correct answer)
- Biological safety cabinet
- Autoclave
Correct answer: Electronic mortar and pestle (or ointment mill)
An electronic mortar and pestle or ointment mill is used in non-sterile compounding to triturate and blend ingredients into a smooth, uniform topical preparation.
Question 5: Which of the following best describes 'garbing' as it applies to sterile compounding?
- Labeling compounded preparations with BUD and lot number
- The process of donning personal protective equipment in the correct order before entering the clean room (Correct answer)
- Calibrating the laminar airflow workbench filters
- Sterilizing equipment using an autoclave
Correct answer: The process of donning personal protective equipment in the correct order before entering the clean room
Garbing refers to the sequential process of putting on required PPE — such as shoe covers, hair covers, gown, mask, and sterile gloves — in the correct order to maintain the cleanliness of the sterile compounding environment.
Question 6: USP <800> standards apply primarily to which category of compounded preparations?
- Nutritional supplements and vitamins
- Hazardous drugs, including many chemotherapy agents (Correct answer)
- OTC topical creams and ointments
- Veterinary compounded medications only
Correct answer: Hazardous drugs, including many chemotherapy agents
USP <800> establishes safety standards for handling hazardous drugs — including many antineoplastic (chemotherapy) agents — to protect healthcare workers, patients, and the environment from exposure.
ExCPT Test Sterile and Non-Sterile Compounding 1
Which USP chapter specifically regulates non-sterile compounding practices in pharmacy?