2. OFFICIAL STATUS AND LEGAL RECOGNITION
2.10. Official Text
Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices. Revisions to official text are provided in Supplements, Interim Revision Announcements, and Revision Bulletins. 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. They contain no mandatory requirements applicable to any official article unless specifically referenced in these General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for use as dietary ingredients and dietary supplements.
2.20. Official Articles
An official article is an article that is recognized in USP or NF. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compendium and an official date is generally or specifically assigned to the monograph.
The title specified in a monograph is the official title for such article. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles.
Official articles include both official substances and official products. An official substance is a drug substance, excipient, dietary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form.
An official product is a drug product, dietary supplement, compounded preparation, or finished device for which a monograph is provided.
2.30. Legal Recognition
The USP and NF are recognized in the laws and regulations of many countries throughout the world. Regulatory authorities may enforce the standards presented in the USP and NF, but because recognition of the USP and NF may vary by country, users should understand applicable laws and regulations. More information about the legal status of the USP and NF is provided in the Mission and Preface.