Abstract

A Primer on USP Chapter 797, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards

Author(s): Newton David W, Trissel Lawrence A

Issue: Jul/Aug 2004 - Wound Care

Page(s): 251-263

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Abstract

The authors are members of the 2000-2005 Sterile Compounding Committee of the Council of Experts of the United States Pharmacopeial Convention. The purpose of this article is to describe the history, process and rationale of United States Pharmacopeia (USP) Chapter <797>; to describe the general USP process and the USP-US Food and Drug Administration relationship regarding official pharmaceutical standards; and to reduce inaccurate and conflicting interpretations of Chapter <7997> by persons and organizations interested in and affected by Chapter <797>. The authors address 15 questions regarding the chapter and process mentioned in the title. Tables provide information regarding a comparison of selected sterile compounding conditions in USP Chapters <797> and <1206> and a comparison of selected attributes of pharmaceutical compounding and manufacturing.

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