![]() ![]() ![]() That are relevant to their use in specific preparations. For general requirements relating to specific monog sections, see section 5, Monograph Components.īecause monographs may not provide standards for all relevant characteristics, some official substances may conform to the USP or NF standard but differ with regard to nonstandardized properties The specification consists of tests, procedures, and acceptance crite-ria that help ensure the identity, strength, quality, and purity of the article. Monographs set forth the article’s name, definition, specification,and other requirements related to packaging, storage, and labeling. An official substance is a drug substance, excipient, diet-ary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form.Īn official product is a drug product, dietary supplement, com-pounded preparation, or finished device for which a monograph is provided. Official articles include both official substances and official products. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles. The title specified in a monograph is the official title for such article. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compen-dium and an official date is generally or specifically assigned to the monograph. General chapters numbered above 2000 apply only to articles that are intended for use as dietary ingredients and dietary supplements.Īn official article is an article that is recognized in USP or NF. They contain no mandatory requirements applicable to any official article unless specifically referenced in these General No-tices, a monograph, or a general chapter numbered below 1000. General chapters numbered from 1000 to 1999 are considered interpretive and are intended to provide information on, give definition to, or describe a particular subject. Revi-sions to official text are provided in Supplements, Interim Revision Announcements, and Revision Bulletins. Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices. Where the require-ments of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and super-sede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference. Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and defaultĬonditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF). Only the online format will contain all current USP–NF content. Starting with the First Supplement to USP 43–NF 38 that will be published on February 1, 2020, print and USB flash drive formats will not be available. Future supplements and editions – including the First and Second Supplements to USP 43–NF 38 – will not be printed or on flash drives. The USP 43–NF 38 is the last edition that will be available in print or on a USB flash drive. ![]()
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