منابع مشابه
USP general chapter <797> pharmaceutical compounding-sterile preparations.
The Society of Nuclear Medicine and Molecular Imaging’s (SNMMI) more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings, and leading advocacy on key issues that affect molecular imaging and therapy research and practice. We appreciate the opportunity to provide comments to the USP in ...
متن کاملBlueprint for implementing USP chapter 797 for compounding sterile preparations.
PURPOSE Guidelines for adopting and successfully implementing the requirements of the United States Pharmacopeia (USP) chapter 797 for compounding sterile preparations are presented. SUMMARY The quality of a compounded sterile preparation (CSP) is directly related to the methods used to ensure that the CSP achieves the desired goal of purity, potency, and sterility. A properly designed, const...
متن کاملA 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 enforce...
متن کاملQuality-Control Analytical Methods: Microbial-Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations.
The standards set forth by the United States Pharmacopeia (USP) Chapter 797 have now been in effect since January 1 or 2004. As the first practice standards of sterile pharmacy compounding in US history, they have "attracted both respect and criticism" because they have also been cited as a practice expectation by the Joint Commission on Accreditation of Healthcare Organizations. USP 797 expand...
متن کاملQuality-Control Analytical Methods: Chemical Testing Aspects of USP chapter 797 for Compounded Sterile Preparations.
The regulations set forth by the United States Pharmacopeia (USP) Chapter <797>, in effect since January 1 of 2004, have generated a great deal of interest because they have established the first practice standards of sterile pharmacy compounding in US history that are enforceable at both the federal and state levels. United States Pharmacopeia Chapter <797> expands the scope of facilities gove...
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ژورنال
عنوان ژورنال: Anesthesia & Analgesia
سال: 2019
ISSN: 0003-2999
DOI: 10.1213/ane.0000000000004390