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`Understanding USP-NF
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`!http://www.usp.org/USPNF/understandingUSPNF.html
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`U.S. PHARMACOPEIA
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`Home > USP-NF ) Understand ing USP-NF
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`Understanding USP-NF
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`What is the USP-NF?
`The United States Pharmacopeia-National Formulary (USP-NF) is a book of public
`pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances,
`excipients, medical devices, and dietary supplements.
`
`Monographs and General Chapters
`The USP-NF is a combination of two official compendia, the United States Phanmacopeia (USP)
`and the National Formulary (NF). Monographs for drug substances and preparations are
`featured in the USP. Monographs for dietary supplements and ingredients appear in a separate
`section of the USP. Excipient monographs are in the NF.
`
`A monograph includes the name of the ingredient or preparation; the definition; packaging,
`storage, and labeling requirements; and the specification. The specification consists of a series
`of tests, procedures for the tests, and acceptance criteria. These tests and procedures require
`the use of official USP Reference Standards. Medicinal ingredients and products will have the
`stipulated strength, quality, and purity if they conform to the requirements of the monograph
`and relevant general chapters.
`
`Tests and procedures referred to in multiple monographs are described in detail in the USP-NF
`general chapters.
`View a s~le USP- NF mon_s,g@Ph la (118KB).
`The General Notices provide definitions for terms used in the monographs, as well as
`information that is necessary to interpret the monograph requirements. USP is proposing to
`revise the General Notices for the USP and NF.
`
`Official recognition
`The U.S. Federal Food, Drug, and Cosmetics Act designates the USP-NF as the official
`compendia for drugs marketed in the United States. A drug product in the U.S. market must
`conform to the standards in USP-NF to avoid possible charges of adulteration and misbranding.
`The USP-NF is also widely used by manufacturers wishing to market therapeutic products
`worldwide. Meeting USP-NF standards is accepted globally as assurance of high quality.
`
`Standards established through a public process
`USP creates and continuously revises USP-NF standards through a unique public-private
`collaborative process, which involves the pharmaceutical industry as well as government and
`other interested parties from anywhere in the world . Learn more about the USP-NF standards(cid:173)
`setting process.
`
`Warning : USP-NF on Unauthorized Web Sites
`The USP-NF is fully copyrighted by the U.S. Pharmacopeia. The officia l Web site of the USP-NF
`Online is www.uspnf.com . Web sites other than the official Web site that claim to offer the
`content of the USP-NF to viewers are not authorized by USP, and are committing copyright
`infringement. The content on those unauthorized Web sites is not va lidated by USP, and may
`include incorrect or out- of-date information. Users shou ld not rely on an unauthorized Web site
`for USP-NF content.
`
`If you are aware of an unauthorized Web site that claims to include the USP-NF, please report
`the Web site's address to webmaster@usp.org .
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