Impact of USP on the Regulatory Approval of the Drug

Abstract

The purpose of this article is to introduce the reader to the United States Pharmacopeia/National Formulary (USP/NF) and to its formal and legal role in the Food and Drug Administration's (FDA) drug regulatory process in the United States¹. It is important to notice the concurrent development of key events in the history of U.S. food and drug law with the development of the USP and NF, two drug standards compendia that originated from different parts of the health care delivery system^2,3. Since their founding in 1820 and 1888, respectively, the United States Pharmacopeia (USP) and the National Formulary (NF) have worked to create public standards for the purity, quality, and strength of medical products, as well as compounding information. In addition to its other regulatory responsibilities, the Food and Drug Administration (FDA), which was formally established in 1938, has always been involved in enforcing purity and potency standards for drug materials, a role that dates back to the Bureau of Chemistry of the Department of Agriculture in 18622,³. Public standards for the strength and purity of medications have been enforced by the federal government since at least 1848, when the USP, a private, nongovernmental organization, first interacted with the government on the matter. To stop the entry of spurious or substandard medications into the country, Congress created the Drug Importation Act in 1848. Drugs that do not meet the "standard established in the United States Pharmacopoeia, and therefore improper, unsafe, or dangerous to be used for medicinal purposes, the articles shall not pass the custom house" are not allowed to enter the United States⁴.