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Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels

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

Issue:  Sep/Oct 2007 - Veterinary Compounding
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Abstract:  The intent of United States Pharmacopeia Chapter <797> Pharmaceutical Compounding—Sterile Preparations is 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. Understanding the different microbial contamination risk levels involved in compounding sterile preparations, how to appropriately assign those risk levels, and the steps needed to maintain sterility decreases the probability of a contaminated preparation.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia, USP Chapter <797>, sterile preparations, microbial contamination, risk levels, standards, pharmacy bulk packages, contrast agents, quality control, drug safety

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

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