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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>

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

Issue:  Mar/Apr 2008 - Compounding Around the World
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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, 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 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 stability, compliance with Chapter

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia, USP standards, USP Chapter <797>, sterile preparations, quality control, quality assurance, risk levels, microbial contamination, stability, packaging, storage, radiopharmaceuticals, allergen extracts, environmental monitoring, engineering controls, facility design, air quality, cleaning, disinfecting, aseptic technique, disinfectants, disinfection

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

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