USP <797> Guidebook to Pharmaceutical Compounding— Sterile Preparations

Overview

The U.S. Pharmacopeia's (USP) Revised General Chapter <797> Pharmaceutical Compounding—Sterile Preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality, is now available in the Second Supplement to USP 31-NF 26, The Pharmacists' Pharmacopeia Second Edition, and the USP <797> Guidebook. This revised version became official on June 1, 2008.

USP is pleased to offer the USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparation, a comprehensive resource that provides easy-to-read versions of the revised General Chapter, along with documents regarding enforceability, General Notices, and the current official text of USP 31 General Chapter <797>.

Resources Contained in Guidebook

This soft cover guidebook contains:

• Introduction: General Chapter <797> and the USP Revision Process
• Enforceability and Recognition of General Chapter <797>
• General Notices
• Revised General Chapter <797> official on June 1, 2008
• USP Sterile Compounding Expert Committee's response to the comments received on the proposed revision to General Chapter <797> published in 2006.

USP General Chapter <797> Frequently Asked Questions