Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 9: Immediate-Use Compounded Sterile Preparations

Author(s):  Allen Loyd V Jr, Okeke Claudia C

Issue:  Sep/Oct 2008 - Veterinary Compounding
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Abstract:  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, 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 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 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 Chap

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia, USP, Chapter <797>, compounded sterile preparations, immediate use, quality control, standards, good compounding techniques

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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