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Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations

Author(s):  Allen Loyd V Jr

Issue:  Nov/Dec 2021 - Volume 25, Number 6
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Abstract:  Throughout the United States Pharmacopeia Monographs and General Chapters, reference is made to additional specific General Chapters. The purpose is to address the situation where the same test or group of tests are required for more than one substance or product monograph or General Chapter and to not repeat the details each time; instead, reference is made to the specific chapter detailing the specific test. United States Pharmacopeia Chapters <795> and <797> both refer to other General Chapters in their content; the purpose of this article is to list the chapters referred to in United States Pharmacopeia <797>, to provide the general purpose of the Chapter, and to include its major headings. Pharmacists should obtain the complete chapter and apply it to their practice as appropriate.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, compounded sterile preparations, United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations, USP, drug admixtures, general chapters, labeling, labels, apparatus, balance repeatability, balance accuracy, microbiological tests, antimicrobial effectiveness testing, sterility tests, microbial contamination, culture media, incubation temperatures, sterilization, membrane filtration, method suitability test, biological testing, bacterial endotoxins test, maximum valid dilution, gel-clot technique, photometric quantitative techniques, pyrogen test, physical tests, packaging and storage requirements, loss on drying, nonsterile preparations

Related Categories: ENVIRONMENTAL , PACKAGING, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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