Improving Quality Assurance in Compounding Sterile Preparations: An Update on USP Chapter <797>

December 7th • 12:45 pm – 1:45 pm • Room 314A

Lawrence A. Trissel, B.S., FASHP

Director, Clinical Pharmaceutics Research

M.D. Anderson Cancer Center

Houston, Texas

Program Description

The United States Pharmacopeia (USP) has published the first enforceable national standards for sterile compounding, USP Chapter <797>. Many state boards of pharmacy are adopting new regulations for their states, the FDA is considering new legislation, and JCAHO is surveying based on these standards. This presentation provides an overview of the content of the USP Chapter <797> to aid practitioners in understanding and interpreting the needed quality assurance measures to protect patients from erroneous and contaminated sterile compounded preparations. Chapter <797> contains standards that define the responsibilities of compounding personnel and descriptions of various quality assurance steps involving environmental control and monitoring, quality testing of compounded dosage forms, personnel aseptic technique evaluation, determination of product risk, storage and beyond use dating, topics for standard operating procedures. The presentation will focus on these quality assurance components that need to be considered and addressed to safely provide compounded sterile products for use in patient care.

Learning Objectives

At the conclusion of this program, participants will be able to:

• Discuss the implications of the USP Chapter <797> national standards for quality assurance of compounded sterile preparations in pharmacies and other locations.

• Describe the environmental engineering controls and monitoring requirements to assure an adequate environment for the compounding of sterile preparations.

• Compare and contrast the various risk levels indicated in USP Chapter <797> for differing compounded sterile preparations and the quality assurance requirements of each.

• Explain the processing and quality assurance requirements of compounding sterile preparations from nonsterile raw ingredients, and how that differs from aseptic processing.

• Discuss the factors that must be considered in establishing a safe beyond period for various types of compounded sterile preparations.

Program number: 204-000-04-432-L04

(1.0 hour continuing education credit)

How to register