You are working as a staff pharmacist at your community hospital when a technician asks you a question regarding sterile compounding in the IV room. Which of the following statements are true? Select all that apply.
A. Gowning/garbing should take place in this order: placement of shoe covers, hair cover, face mask, proper hand washing technique, donning of gown, and finally the donning of sterile gloves.
B. Based on USP 797, a Category 1 compounded sterile preparation (CSP) is defined as a preparation that must be used within 12 hours when stored at controlled room temperature or 24 hours refrigerated.
C. Cleaning of the hood should take place at the beginning of each shift, every 30 minutes while compounding, in case of spills or suspected contamination, and between different preparations.
D. Horizontal or vertical positive airflow pressure workbenches are used for the compounding of hazardous medications while vertical negative airflow pressure biological safety cabinets (BSCs) are used for nonhazardous medications.
E. Category 2 CSPs if aseptically processed with one or more nonsterile starting components have a beyond use date of 30 days when stored in a freezer.
Students are often surprised when reviewing the NAPLEX Competency Statements, discovering that approximately 33% of the exam involves what are termed "Area 2 questions". These include safe and accurate preparation, compounding, dispensing, and administration of medications and provision of health care products. This week's question focuses on sterile compounding.
Answers A, B, and C are the correct options. As a pharmacist in a hospital setting, it is important to know information regarding sterile compounding including proper gowning/garbing, sterility risks of compounding, and staying up to date on USP regulations.
Answer D is incorrect because horizontal or vertical positive airflow pressure workbenches are used for compounding nonhazardous medications. The vertical negative airflow pressure BSC is used to compound hazardous medications.
Answer E is incorrect as Category 2 CSPs have a beyond use date of 45 days when stored in freezer, regardless of how many sterile or nonsterile starting components are used when no sterility testing is performed.
It is important to note that USP 797 was revised in June 2019, changing a number of categories and definitions which would be important to review prior to the exam. This is an area where extreme detailed knowledge and focus is required to answer questions correctly. The smallest detail can mean the difference in answering the question correctly.
Have a great week!