“OFFICIAL” AND “OFFICIAL ARTICLES”
The word “official”, as used in this Pharmacopeia or with reference hereto, is synonymous with “Pharmacopeial”, with “USP”, and with “compendial”.
The designation “USP” in conjunction with the official title or elsewhere on the label of an article indicates that a monograph is included in the USP and that the article purports to comply with all applicable USP standards. The designation “USP” on the label may not and does not constitute a representation, endorsement, or incorporation by the manufacturer's labeling of the informational material contained in the USP monograph, nor does it constitute assurance by USP that the article is known to comply with USP standards. An article may purport to comply with a USP standard or other requirements only when the article is recognized in the USP. The standards apply equally to articles bearing the official titles or names derived by transposition of the definitive words of official titles or transposition in the order of the names of two or more active ingredients in official titles, whether or not the added designation “USP” is used. Names considered to be synonyms of the official titles may not be used for official titles.
Although both compendia, the United States Pharmacopeia and the National Formulary, currently are published under one cover, they remain separate compendia. The designation USP–NF or similar combination may be used on the label of an article, provided the label also bears a statement such as “Meets NF standards as published by the USP,” indicating the particular compendium to which the article purports to apply.
Where an article differs from the standards of strength, quality, and purity, as determined by the application of the assays and tests set forth for it in the Pharmacopeia, its difference shall be plainly stated on its label. Where an article fails to comply in identity with the identity prescribed in the USP, or contains an added substance that interferes with the prescribed assays and tests, such article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in the Pharmacopeia.
Articles listed herein are official and the standards set forth in the monographs apply to them only when the articles are intended or labeled for use as drugs, as nutritional or dietary supplements, or as medical devices and when bought, sold, or dispensed for these purposes or when labeled as conforming to this Pharmacopeia.
An article is deemed to be recognized in this Pharmacopeia when a monograph for the article is published in it, including its supplements, addenda, or other interim revisions, and an official date is generally or specifically assigned to it.
The following terminology is used for distinguishing the articles for which monographs are provided: an official substance is an active drug entity, a recognized nutrient, a dietary supplement ingredient, or a pharmaceutic ingredient (see also NF 24) or a component of a finished device for which the monograph title includes no indication of the nature of the finished form; an official preparation is a drug product, a nutritional supplement, dietary supplement, or a finished device. It is the finished or partially finished (e.g., as in the case of a sterile solid to be constituted into a solution for administration) preparation or product of one or more official substances formulated for use on or for the patient or consumer; an article is an item for which a monograph is provided, whether an official substance or an official preparation.
Designating Conformance with Official Standards—
When the letters “USP” or “NF” or “USP–NF” are used on the label of an article to indicate compliance with compendial standards, the letters shall appear in conjunction with the official title of the article or when appropriate, with the ingredients contained therein. The letters are not to be enclosed in any symbol such as a circle, square, etc., and must appear in block capital letters.
If a dietary supplement purports to be or is represented as an official product and such claim is determined by the USP not to be made in good faith, it is the policy of the USP to seek appropriate legal redress.
Products Not Marketed in the United States—
Interest in the USP outside the United States has always existed. From time to time, monographs may be adopted for articles not legally marketed in the United States as a service to authorities in other countries where USP standards are recognized and applied. Appearance of any such monograph does not grant any marketing rights whatsoever, and the status of the article in the United States must be checked with the U.S. Food and Drug Administration in the event of any question.
Nutritional and Other Dietary Supplements—
The designation of an official preparation containing one or more recognized nutrients or dietary supplement ingredients as “USP” or the use of the designation “USP” in conjunction with the title of such nutritional or dietary supplement preparation may be made only if the preparation meets all the applicable requirements contained in the individual monograph and general chapters. Any language modifying or limiting this representation shall be accompanied by a statement indicating that the article is “not USP”, and indicating how the article differs from the standards of strength, quality, or purity as determined by the application of the tests and assays set forth in the compendia. Any additional ingredient in such article that is not recognized in the Pharmacopeia and for which nutritional value is claimed shall not be represented nor imply that such ingredient is of USP quality or recognized by USP. If a preparation does not comply with all applicable requirements but contains nutrients or dietary supplement ingredients that are recognized in the USP, the article may not designate the individual nutrients or ingredients as complying with USP standards or being of USP quality without designating on the label that the article itself does not comply with USP standards.
