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

mine (antihistamine) and other ingredients for modernization, in part due to concerns regarding the toxicity of certain impurities (e.g., p-aminophenol in acetaminophen). USP has advanced work on these ingredient monographs, which, once final, will have widespread impact due to the ubiquity of products containing these ingredients. Among the areas USP would like feedback on is the process for revising the dosage form (finished drug product) monographs. For acetaminophen alone, USP currently has 37 individual monographs for various liquid and solid dosage forms.

"Prescription and many over-the-counter drugs are regulated differently under the law, but it is equally important for both categories of products to be of high quality, supported by up-to-date, scientifically sound public standards that all manufacturers must adhere to," said CDER Director Dr. Woodcock. "Over-the-counter medicines are unique in that they are heavily relied upon across the patient population, are often used without healthcare provider oversight, and are available in a wide variety of dosage forms. All these factors make updating public standards for these medicinesstarting with those that are most widely usedall the more critical."

"Modernization of over-the-counter medicines and ingredients is an important public health activity, and it is one that will be optimally achieved through a robust partnership among regulators, industry and USP," said Karen Russo, Ph.D., vice president of small molecules at USP. "As we determine the most productive path forward for tackling these updates, we seek input that will allow us to proceed in the most efficient mannerin order to maximize the benefit to patient health. USP is considering a number of approaches for addressing dosage forms of these medicines, and how we proceed will impact industry significantly. This workshop is a critical way for us to solicitand for industry, consumer groups and others to providethe feedback we need."'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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