Quality-Control Analytical Methods: Microbial-Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations.

The standards set forth by the United States Pharmacopeia (USP) Chapter 797 have now been in effect since January 1 or 2004. As the first practice standards of sterile pharmacy compounding in US history, they have "attracted both respect and criticism" because they have also been cited as a practice expectation by the Joint Commission on Accreditation of Healthcare Organizations. USP 797 expands the scope of facilities governed by the regulatinos and defines the practices covered, emphasizing the importance of environmental quality and control, verification of accuracy and sterility, training and evaluation, quality control after preparations leave the pharmacy, patient monitoring and adverse events reporting. The purpose of this article is to help the reader understand the criteria set forth by USP Chapter 797 regarding finished-product testing, including criteria for the microbial-testing aspects of sterility testing (USP Chapter 71) and endotoxin (pyrogen) testing (USP Chapter 85).