ABSTRACT

The United States Pharmacopeia (USP) was established in 1820 by medical practitioners to ensure quality and correct nomenclature of therapeutic preparations. Today, over 180 years after the first USP was published, USP is the oldest continuously published pharmacopeia in the world and is the only nongovernment compendia. In 1974, USP merged with the National Formulary (NF) and the current USP-NF contains about 385 monographs for excipients. The USP mission statement states that, ‘‘the United States Pharmacopeia promotes the public health by establishing and disseminating officially recognized standards of quality and authoritative information for the use of medicines and health care technologies by health professionals, patients, and consumers.’’ Although USP is a private organization, federal and state laws in the United States have allowed adoption of USP standards for many purposes. According to the provisions of the 1938 Federal Food, Drug, and Cosmetic Act, USP standards are enforceable by the Food and Drug Administration for drugs manufactured and sold in, or imported into, the United States. Standards established by USP are also recognized by law in Canada and by practice in many other countries.