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

David W. Newton, BS, PhD, FAPhA Bernard J. Dunn School of Pharmacy Shenandoah University Winchester, Virginia Lawrence A. Trissel, BS, RPh, FASHP M.D. Anderson Cancer Center The University of Texas Houston, Texas Editor’s Note In January 2004, Chapter <797> in the United States Pharmacopeia 27 became the first practice standards for sterile pharmacy compounding in US history that may be enforced by the US Food and Drug Administration. Dr. Newton is chairman and Mr. Trissel is a member of the 2000–2005 Sterile Compounding Committee of the Council of Experts of the United States Pharmacopeial Convention. Dr. Newton and Mr. Trissel are not available to interpret Chapter <797> to persons or organizations outside the United States Pharmacopeial Convention. An outlined summary of the features of Chapter <797>, whose author represents a vendor of isolation chambers, was recently published in the International Journal of Pharmaceutical Compounding.