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Sterile Compounding: History and Basics - Review of USP 797 - Aseptic Technique 2020/2021

Pharmacists routinely compound medications in response to patient needs. The Massachusetts Board of Pharmacy requires that pharmacists engaged in sterile products compounding obtain additional education specific to this area in order to maintain their licensure. This course will provide the background for the need for such education and provide concrete examples of best practice.

Learning Objectives

Upon completion of this activity, the participant should be able to:

  • Define general principles of USP <797>.
  • Identify how complying with USP <797> can prevent medication errors associated with contamination.
  • Describe examples of deviations from USP <797> associated with adverse events related to CSPs.
  • Describe the differences in manipulations when compounding sterile compounding sterile products in a vertical versus a horizontal laminar airflow hood.


Kathleen M. Gura, PharmD, BCNSP, FASHP, FPPAG, FASPEN 
Kathleen M. Gura, PharmD, BCNSP, FASHP, FPPAG, FASPEN is the Clinical Research Program Manager and a clinical pharmacist with the Clinical Nutrition Service in the Division of Gastroenterology, Hepatology, and Nutrition at Boston Children's Hospital. She is also an Assistant Professor of Pediatrics at Harvard Medical School and Associate Professor of Pharmacy Practice at the MCPHS University in Boston. Certified as a Nutritional Support Pharmacist, Dr. Gura is a Fellow of ASPEN ASHP and, the Pediatric Pharmacy Advocacy Group. She is the recipient of numerous awards including the 2012 Distinguished Pharmacist award from the American Society for Parenteral and Enteral Nutrition and the 2008 ASPEN Serlick Award for safe practice in the field of parenteral nutrition. In 2009 she was awarded Drug Therapy Research Award by the American Society of Health Systems Pharmacists for her work involving IV lipid emulsions. She has served on several expert committees involved with USP 797 and USP 799. Kathy has authored over 150 peer-reviewed publications and book chapters. Her research was funded by the March of Dimes and the FDA’s Orphan Drug Development Program which led to the approval of Omegaven in July 2018.


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Release Date: October 16, 2020
Expiration Date: October 18, 2021
Contact Hours: 1.5
Universal Activity Number: 0026-0000-20-021-H03-P
ACPE Topic Designator: Law

MA licensed pharmacists, please refer to MA BOP policy 2020-10 section VII for further information on the use CE credits designated for pharmacy law (03) and compounding (07) to meet annual licensure requirements. Pharmacists licensed outside of MA should refer to their own state boards of Pharmacy for more information.

Registration Fee: Free to MCPHS Alumni and full-time employees; $12.00 for all other professionals.