USP–NF is published in continuing pursuit of the mission of USP: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
This section provides background information on the United States Pharmacopeial Convention (USP), as well as general information about the 38th revision of the United States Pharmacopeia (USP 38) and the 33rd edition of the National Formulary (NF 33) and their Supplements. Unless otherwise noted, the text in USP 38–NF 33 is official May 1, 2015, the text in the First Supplement to USP 38–NF 33 is official August 1, 2015, and the text in the Second Supplement to USP 38–NF 33 is official December 1, 2015.
On January 1, 1820, 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopeia for the United States. These practitioners sought to create a compendium of the best and most fully established medicines, give them useful names, and provide recipes for their preparation. Nearly one year later, on December 15, 1820, the first edition of The Pharmacopoeia of the United States was published. Over time, the nature of the United States Pharmacopeia (USP) changed from being a compendium of recipes to a compendium of documentary standards for identity and quality that typically involve reference materials used as comparison standards in specified tests and assays. The publishing schedule of USP also changed over time. From 1820 to 1942, USP was published at 10-year intervals; from 1942 to 2000, at five-year intervals; and beginning in 2002, annually.
In 1888 the American Pharmaceutical Association published the first National Formulary under the title The National Formulary of Unofficinal [sic] Preparations (NF). Both USP and NF were recognized in the Federal Food and Drugs Act of 1906 and again in the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act). In 1975, USP acquired the National Formulary (NF), which now contains excipient standards that also call for reference materials. USP continues to develop USP and NF, through the work of the Council of Experts, into compendia that provide standards for articles based on advances in analytical and metrological science. As these and allied sciences evolve, so do USP and NF.
USP–NF contains official substance (ingredient) and product monographs for official articles recognized in USP–NF. The terms official substance, official preparation, and official article are defined in the General Notices and Requirements (General Notices). With few exceptions, all articles for which monographs are provided in USP–NF are legally marketed in the United States or are contained in legally marketed articles. USP–NF also includes monographs for compounded preparations.
A USP–NF monograph for an official substance, product, or preparation may consist of various components, including the article's name; definition; packaging, storage, and other requirements; and a specification. The specification consists of a series of universal tests (description, identity/identification, impurities, assay) and specific tests, one or more analytical procedures for each test, and acceptance criteria. Ingredients are defined as either drug substances or excipients. An excipient is any component, other than the active substance(s), intentionally added to the formulation of a dosage form. Excipients are not necessarily inert. Drug substances and excipients may be synthetic, semi-synthetic, drawn from nature (natural source), or manufactured using recombinant technology. Drugs that consist of larger molecules and mixtures requiring a potency test are usually referred to as biologicals or biotechnological articles.
General chapters provide frequently cited procedures, sometimes with acceptance criteria, in order to compile into one location repetitive information that is applicable to many monographs. New and revised monographs and general chapters and omitted monographs from this edition are indicated in the Admissions section.
USP's governing, standards-setting, and advisory bodies include the USP Convention, the Board of Trustees, the Council of Experts and its Expert Committees, Expert Panels, and staff. Additional volunteer bodies include Stakeholder Forums, Project Teams, and Advisory Groups, which act in an advisory capacity to provide input to USP's governing, standards-setting, and management bodies.