Considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 5: verification of accuracy, sterility, and sterilization of compounded preparations.

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 administation of compounded sterile preparations to patients. The intent of Chapter 797 is simply to prevent patient harm and fatalitites that may result from nosterility, 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 applied to sustain solution stablity, compliance with Chapter 797 should be the goal of any facility where sterile preparations are compounded. Many pharmacies have already achieved compliance with Chapter 797, and those that have already met the new standards seem to support them strongly. This article discusses procedures for verification of the accuracy, sterility, and sterilization of compounded preparations. The importance of United States Pharmacopeia Chapter 71, 1035, and 1211, all of which contain vital information, is also discussed.