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Basics of Compounding for the Implementation of United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 1

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

Issue:  May/Jun 2007 - Pain Management
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Abstract:  United States Pharmacopeia 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, 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 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

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia Okeke, PhD, RPh, United States Pharmacopeia, USP Chapter <797>, sterile preparations, quality control, contamination, endotoxin, stability, compounding practice standards, testing, gap analysis

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

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