Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding sterile preparations, part 6: 2008 revisions to chapter 797.

United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in the preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, instillation, or irrigation, including preparation, storage and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patients. The intent of Chapter 797 is simply to prevent patient harm and fatalities that may result from nonsterility , excessive endotoxin load, large content errors in strength of correct ingredients, or the presence of incorrect ingredients. Because the achievement of sterility requires that facilities meet minimum cleanliness standards, that personnel be trained adequately and undergo periodic testing and training in sterilization techniques, and that appropriate principles and practices be appied to sustain solution stability, compliance with Chapter 797, and those that have already met the new standards seem to support them strongly. A number of significant changes have been made to Chapter 797, and this article discusses these changes.