USP and its Standards
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, VII). USP’s mission is “to improve the health of people around the world 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 typically expressed in the article's monograph, the General Notices, and applicable general chapters (such as General Chapter <1> Injections). Depending on the particular compendium, USP monographs and general chapters may include standards for the identity, as well as the strength, quality and purity of medicines, food ingredients, or dietary supplements, for both products and constituent ingredients. They also may include standards for packaging and labeling. USP Reference Standards are often specified as a component of particular standards, serving as required comparison standards in particular tests and assays. 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; most standards in USP–NF have, for example, been adopted in the U.S. under federal law. USP has no role in enforcement; that is left to FDA and other government authorities in the U.S. and elsewhere.
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)
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)). Such drugs 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 represented as conforming to specifications in USP–NF will be deemed a misbranded food if it fails to so conform. See FDCA Section 403(s)(2)(D).
USP has no role in enforcement of its standards. Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere.