Frequently Asked Questions: USP and its Standards

  1. What is USP?
  2. What does compliance with USP–NF standards mean?
  3. What is the role of USP standards in federal law?
  4. What labeling requirements does USP establish?

 


 

  1. What is USP?

    The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public compendial quality standards for medicines and other articles (Bylaws, Articles II, and VII). USP’s mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are expressed in the article's monograph, the General Notices, and applicable general chapters (such as General Chapter <1> Injections). USP’s primary compendia of standards are the United States Pharmacopeia and the National Formulary (USP–NF). USP standards may be adapted or adopted by any organization or government worldwide. USP has no role in enforcement; that is left to FDA and other government authorities in the U.S. and elsewhere.

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  2. What does compliance with USP–NF standards mean?

    An article of commerce that is recognized in the USP–NF complies with USP–NF standards when it meets all of the requirements stated in the article’s monograph, applicable General Chapters, and the General Notices (with monograph requirements superseding those of the General Chapters and General Notices, in any cases where requirements differ). Applicable standards apply at all times in the life of an article, from production to expiration. Thus, any official article is expected to meet the compendial standards if tested, and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance. Frequency of testing and sampling are left to the preferences or direction of those performing compliance testing, and other users of USP–NF, including manufacturers, buyers, or regulatory authorities. (General Notices, section 3.10)

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  3. What is the role of USP standards in federal law?

    Congress has consistently provided a role for USP standards in the adulteration and misbranding provisions of successive federal food and drug legislation, beginning with the Pure Food and Drugs act of 1906 and continuing to today with the Federal Food, Drug, and Cosmetic Act (FDCA). Under Federal law, a drug with a name recognized in USP–NF must comply with the current version of compendial standards deemed official by USP, or risk being deemed adulterated, misbranded, or both (FDCA 501(b) and 502(e)(3)(b); FDA regulations 21 CFR 299.5(a&b)). Biologics, including those approved by FDA under the Public Health Service (PHS) Act, are also considered drugs subject to the FDCA adulteration and misbranding provisions, including USP standards (FDCA 201(g), 301(a-c), and PHS Act 351(j). Drugs and biologics recognized in USP must comply with identity standards; and must also comply with standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs (FDCA 501(b); 21 CFR 299.5(c)). In addition (as exemplified by the ferrules and cap overseals labeling standard), to avoid being deemed misbranded, drugs recognized in USP–NF must also be packaged and labeled in compliance with compendial standards (FDCA 502(g)). With regard to dietary supplements (regulated separately under the Dietary Supplement Health and Education Act, DSHEA), a dietary supplement that is covered by specifications in the USP–NF and is represented as conforming to those specifications shall be deemed to be misbranded if it fails to so conform. See FDCA Section 403(s(2)(D).

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  4. What labeling requirements does USP establish?

    Consistent with its mission and governing authority, USP establishes standards for articles recognized in USP–NF, which are expressed in an article’s monograph, applicable general chapters, or the General Notices (see GN 3.10). Specifically regarding labeling, USP General Notices has a section devoted exclusively to the subject of labeling (see GN 10.40 Labeling; “Articles in these compendia are subject to compliance with such labeling requirements as may be promulgated by governmental bodies in addition to the compendial requirements set forth for the articles.”). Like other compendial requirements, labeling requirements may be contained in individual monographs or, like these revisions to General Chapter <1> Injections, in general chapters that are applicable to multiple products. Note also that the current labeling-related provisions, and other labeling-related provisions, will be addressed in a new General Chapter <7>.

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