NOTICE: Due to a lapse in annual appropriations, most of this website is not being updated. Learn more.
Form submissions will still be accepted but will not receive responses at this time. Sections of this site for programs using non-appropriated funds (such as NVLAP) or those that are excepted from the shutdown (such as CHIPS and NVD) will continue to be updated.
An official website of the United States government
Here’s how you know
Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
Project Team 4, the 2000-2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, USP Staff, Consultant: Official USP Reference Standards: Metrology Concepts, Overview, and Scientific Issues and Opportunities
Published
Author(s)
Reenie M. Parris
Abstract
The United States Pharmacopeia (USP) is a private standards-setting body created in 1820 by practitioners who wished to promote the quality of therapeutic products in commerce. The principal product of USP, then and now, is the United States Pharmacopeia (USP), to which was added the National Formulary (NF) in 1975. The two compendia are published as a combined text annually (USP-NF). Originally a book of process standards, USP-NF evolved over time into compendia containing primarilyproduct standards that are expressed in monographs for therapeutic ingredients, products,and excipients. As a public health service, USP supplies official USP Reference Standards to manufacturers and others who wish to test an article according to selected procedures of a monograph or General Chapter. During the past decade, understanding of USP monographs and official USP Reference Standards as a means of controlling the quality of a therapeutic article has evolved, based on advances in metrology, on activities in the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), and on considerations by the USP Council of Experts and its Expert Committees and USP staff. This article discusses the evolution of this understanding, focusing on drug substances and excipients for well characterized small molecules and their corresponding dosage forms.
Citation
Journal of Pharmaceutical and Biomedical Analysis
Volume
40
Pub Type
Journals
Keywords
metrology, monographs, reference standards, specifications, United States Parmacopeia, USP-NF
Parris, R.
(2006),
Project Team 4, the 2000-2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, USP Staff, Consultant: Official USP Reference Standards: Metrology Concepts, Overview, and Scientific Issues and Opportunities, Journal of Pharmaceutical and Biomedical Analysis
(Accessed October 15, 2025)