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The word “official,” as used in this National Formulary or with reference hereto, is synonymous with “National Formulary,” with “NF,” and with “compendial.”
The designation NF in conjunction with the official title or elsewhere on the label of an article is a reminder that the article purports to comply with NF standards; such specific designation on the label does not constitute a representation, endorsement, or incorporation by the manufacturer's labeling of the informational material contained in the NF monograph, nor does it constitute assurance by NF that the article is known to comply with NF standards. An article may purport to comply with an NF standard only when the article is recognized in the NF. 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 ingredients in official titles, whether or not the added designation “NF” 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 National Formulary, its difference shall be plainly stated on its label. Where an article fails to comply in identity with the identity prescribed in the NF, or contains an added substance that interferes with the prescribed assays and tests, such article shall be designated by a name that is clearly distinguished and differentiated from any name recognized in the National Formulary.
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 National Formulary.
An article is deemed to be recognized in this National Formulary 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.
Because of differing characteristics not standardized by this National Formulary, all sources or types of some excipients may not have identical properties with respect to use in a specific preparation. To assure interchangeability in such instances, users may wish to ascertain final performance equivalency or determine such characteristics prior to use.