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Definition of National Formulary

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National Formulary: Full name: United States Pharmacopeia and National Formulary (USP-NF). An official publication, issued first by the American Pharmaceutical Association and now yearly by the United States Pharmacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs. The book contains two separate official compendia -- the USP and the NF.

The United States Pharmacopeia (USP), established in 1820, contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for drug substances, dosage forms, and other therapeutic products, including nutritionals and dietary supplements.

The National Formulary (NF), established in 1888 by the American Pharmaceutical Association, includes standards for excipients, botanicals, and other similar products. USP purchased the NF in 1975, combining the two publications under one cover, creating the USP-NF.

USP-NF monographs contain specifications (tests, procedures, and acceptance criteria) that helps ensure the strength, quality, and purity of named items. The USP-NF also contains monographs and general approaches to ensure the quality of compounded preparations. USP-NF monographs, which are recognized worldwide, may be enforceable by the US Food and Drug Administration (FDA) and also by state agencies in the US.

Reviewed on 5/13/2016

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