USP: Setting Ingredient Standards

February 16, 2009 | Contact Author | By: Lawrence Evans III, Ph.D., Stefan Schuber, Ph.D., United States Pharmacopeia
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  • Keywords/Abstract

Keywords: US Pharmacopeia | standards | regulations | quality | FDA

Abstract: This article gives an overview of the standards-setting process used in the United States Pharmacopeia and National Formulary (USP–NF), an annual publication that helps to ensure the integrity of ingredients used in cosmetics, toiletries and other personal care products.

An article published in the Wall Street Journal described the United States Pharmacopeial Convention Inc. (USP) as an “obscure group.” Among health care professionals and the pharmaceutical and personal care industries, however, USP is anything but obscure. USP is a non-governmental, non-profi t pharmacopeia that has been setting standards for drugs and other articles for nearly 185 years. Although some believe that it is exclusively focused on the pharmaceutical industry, USP has a prominent role in setting standards in the cosmetic and personal care industry as well. The purpose of this article is to examine the role of USP in the cosmetics and personal care industry. Three major aspects of USP directly affect the cosmetics and personal care industry:
• The United States Pharmacopeia– National Formulary (USP–NF)
• The standards-setting process
 • Reference standards

USP–NF USP–NF is an annual publication of standards that establish the strength, quality and purity for medicines, dietary supplements and their ingredients, excipients and other articles. These standards are enforceable by the U.S. Food and Drug Administration (FDA). USP–NF specifi es tests, analytical procedures and acceptance criteria. Using the procedures described in USP–NF can be cost-effective and can lessen the regulatory burdens for most companies, especially those with limited resources. The development and evaluation of analytical procedures is often a costly and laborious endeavor. However, suppliers and manufacturers can signifi cantly reduce this cost by using the well-established procedures in the USP–NF.