NAPLEX Question of the Week: Compounding Standards

Compounding of hazardous drugs is the question for the week!

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Which of the following is/are true when it comes to compounding hazardous drugs (HD)? Select all that apply. 


A. USP Chapter 800 contains the standards for handling hazardous drugs

B. The list of hazardous drugs is maintained by National Institute for occupational safety and health (NIOSH) 

C. When compounding doxorubicin, a vertical laminar airflow workbench (LAFW) should be used

D. A single pair of sterile gloves should be worn when compounding an antineoplastic for intravenous use

E. When compounding sterile hazardous drugs, the beyond-use date (BUD) is found in USP Chapter 797


Answers with rationale: 

Answers A, B, and E are correct

When compounding HD, you must follow USP Chapter 797 for sterile compounding and USP 795 for non-sterile compounding in addition to USP Chapter 800 which give standards for proper handling of HD making answer A and E correct. 

All pharmacies that handle hazardous drugs must compile an updated list every 12 months using the current NIOSH HD list. The most recent release from NIOSH has been a 2020 draft following the 2016 published list. When compounding hazardous drugs, a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) must be used, making answer C incorrect. Furthermore, all hazardous drugs must be stored and prepared in a negative pressure ISO 7 clean room. Answer D is incorrect because when compounding sterile HD, a set of sterile gloves must be worn on top of another pair gloves. Both pairs must be chemotherapy gloves that meet American Society for Testing and Materials (ASTM) standard D6978. 

NABP Competency Statements Covered:

5.2 – Techniques, procedures, or equipment for hazardous or non-hazardous sterile products
5.3 – Techniques, procedures, or equipment for hazardous or non-hazardous non-sterile products

Christopher M. Bland

Clinical Professor, University of Georgia College of Pharmacy

Dr. Christopher M. Bland is a Clinical Professor at the University of Georgia College of Pharmacy at the Southeast GA campus in Savannah, GA. Dr. Bland has over 20 years of academic and clinical experience in a number of clinical areas. He is a Fellow of both the Infectious Diseases Society of America as well as the American College of Clinical Pharmacy. He is co-founder of the Southeastern Research Group Endeavor, SERGE-45, with over 80 practitioners across 14 states involved. Dr. Bland serves as Associate Editor for the NAPLEX Review Guide 4th edition as well as Editor-In-Chief for the Question of the Week. He has provided live, interactive reviews for more than 10 Colleges/Schools of Pharmacy over the course of his career.