USP 38 – NF 33 (2015)

The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).

Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the "compendia") and to all general chapters unless specifically stated otherwise. Where the requirements of an individual monograph differ from the General Polices of a general chapter, the

monograph requirements apply and supersede the requirements of the General Notices or the general chapter,

whether or not the monograph explicitly states the difference.

Officio/ 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 decade a particular subject. They contain no mandatory requirements applicable to any official article unless specifically referenced 1n 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 other names considered to be noniron of the official titles may not be used .as substitutes 􀀼,or 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 throu9hout the world. Regulatory authorities may enforce the standards presented in the 115P and NF. but because recognition of the USP and NF may

vary by country, users should understand applicable laws and regulations. In the United States under the Federal

Food, Drug, and Cosmetic Act (FDCA), both USP and NF are recognized as official compendia. A drug with a name recognized in must comply with compendia standards or be USP-NF deemed adulterated, misbranded, or both.

See, e.g., FDCA § 501 (b) and 502{e)(3)(b); also FDA regulations, 21 CFR 299.STo avoid being deemed

adulterated, such drugs must also comply with compendia! standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs. See, e.g., FDCA § 501 (b) and 21 CFR § 299.S(c). In addition, to avoid being

deemed misbranded, drugs recognized in USP-NF must also be packaged and labeled in compliance with compendial

standards. See FDCA § 502(9).

A dietary supplement represented as conforming to specifications in USP will be deemed a misbranded food if it fails to so conform. See FDCA 403(s)(2)(D).

Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere. USP has no role in enforcement.