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FDA-USP workshop to preview updated OTC standards
Date:8/15/2011

Rockville, Md., August 15, 2011 Updated public standards incorporating new tests for impurities as well as more modern technologies to help ensure the quality of over-the-counter (OTC) ingredients and products will be key areas of focus for a September 8-9, 2011, workshop co-sponsored by the U.S. Food & Drug Administration (FDA) and the U.S. Pharmacopeial Convention (USP).

In addition to providing updates on new standards for acetaminophen and diphenhydraminetwo very commonly used OTC ingredientsthe FDA-USP OTC Drug Substances and Drug Products Workshop will solicit feedback on broader activities that will impact the OTC segment of the pharmaceutical industry, including future priorities for products and ingredients that require modernized quality standards and a path forward for developing standards for categories of products not currently addressed by USP such as mouthwashes and medicated shampoos. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER), will keynote the event.

The workshop is an extension of a joint initiative of FDA, USP and the Consumer Healthcare Products Association (CHPA) to modernize specific USP monographs for OTC products and ingredients by adding impurities/degradants tests where no tests exist and/or incorporating modern analytical techniques and technologies for those that are outdated by today's scientific standards. The effort is part of a larger USP initiative to modernize a significant subset of its written standards, or monographs, contained in its drug compendia, the United States PharmacopeiaNational Formulary (USPNF). Drug and ingredient manufacturers marketing products, including OTC products, in the United States are required by law to adhere to existing USPNF monographs. These standards are enforceable by FDA, and are also used in more than 130 countries around the world.

Under this initiative, FDA prioritized acetaminophen (pain and fever relief), diphenhydra
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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