Considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 9: immediate use compounded sterile preparations

Loyd V Allen, Claudia C Okeke
International Journal of Pharmaceutical Compounding 2008, 12 (5): 440-3
United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in the preparation of sterile compounds of application, implantations, 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 patient. 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 the 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 stability, compliance with Chapter 797, and those that have already met the new standards seem to support them strongly. Chapter 797 sets standards for all compounded sterile preparations, including those for immediate use. This article discusses the techniques and standards used when immediate-use compounded sterile preparations are needed.

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