USP and its Standards

The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in Washington, D.C., in 1820 that develops and disseminates public standards for medicines and other articles (Bylaws, Article II). 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 expressed in the article's monograph, the General Notices, and applicable general chapters (such as General Chapter <1> Injections). USP monographs and general chapters typically include standards for the identity, as well as the strength, quality and purity of medicines, food ingredients, and dietary supplement products and ingredients. They also may include standards for packaging and labeling. USP’s primary compendia of standards are the United States Pharmacopeia and the National Formulary (USP-NF).

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)