Basics of compounding for the implementation of United States pharmaceopeia chapter 797 pharmaceutical compounding-sterile preparations, part 1

Loyd V Allen, Claudia Okeke
International Journal of Pharmaceutical Compounding 2007, 11 (3): 230-6
United States Pharmaceopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, installation, 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 cleaner facilities, trained personnel undergoing periodic testing and training in sterilization, and application of principles and practices to sustain solution stability, compliance to Chapter 797 should be met by any facility where sterile preparations are compounded. Many pharmacies have already become compliant with Chapter 797, and those that have already met the new standards seem to strongly support them.

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