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Basics of Compounding: United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 10: First Revision: The Main Changes, Events, and Rationale

Author(s):  Okeke Claudia C, Newton David W, Kastango Eric S, Allen Loyd V Jr

Issue:  Nov/Dec 2008 - Arthritis and Immunological Diseases
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Abstract:  From 2005 to 2007, the United States Pharmacopeia’s Sterile Compounding Committee revolutionized sterile preparation practices with a thorough revision to a monumental standard. By revising United States Pharmacopeia General Chapter <797>, they defined safe procedures for compounded sterile preparations in profound detail. From proper hygiene to air quality control, the revised Chapter <797> aims to reduce complications related to treatment with compounded sterile preparations, offers invaluable information to those involved in the compounding process, and establishes standards to improve the quality of the compounding process. The vast intellect, innovative review process, and dedicated research incorporated into this revision have assisted those involved with compounding pharmacy around the world.

Related Keywords: Claudia C. Okeke, BSPharm, PhD, David W. Newton, BSPharm, PhD, FAPHA, Eric S. Kastango, BSPharm, MBA, FASHP, Loyd V. Allen, Jr., PhD, RPh, United States Pharmacopeia, Chapter <797> revisions, compounded sterile preparations, microbial contamination prevention, buffer areas, environmental monitoring

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

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