An Overview of United States Pharmacopeia Chapter <795> and American Society of Health-System Pharmacists Guidelines for Nonsterile Compounding

Author(s):  McElhiney Linda F

Issue:  Nov/Dec 2009 - Geriatric Compounding
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Abstract:  Hospital pharmacy departments should be compliant with the standards of United States Pharmacopeia Chapter <795>. In order to remain compliant, small hospitals and institutions must properly train their staff to ensure that their compounding procedures and the resultant preparations are in compliance with the standards in Chapter <795>. For reasons outlined in this article, it is more challenging for larger hospitals and institutions to remain compliant; they require a specialized staff that must keep all compounding personnel updated with the constant changes in compounding practices and standards outlined by the United States Pharmacopeial Convention. This article summarizes Chapter <795> on Pharmaceutical Compounding—Nonsterile Preparations, key points in the American Society of Health-System Pharmacists TAB guidelines on compounding nonsterile products in pharmacies, and author recommendations on applying these standards and guidelines in hospital pharmacy departments.

Related Keywords: Linda F. McElhiney, PharmD, RPh, United States Pharmacopeia Chapter <795), USP, hosital pharmacy, regulatory compliance, ASHP, nonsterile preparations, facilities, environmental controls, quality control

Related Categories: ENVIRONMENTAL , LEGAL, STABILITIES, COMPATIBILITIES, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, HOSPITAL PHARMACY

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