FDA, USP co-sponsors OTC drug products workshop

Published on August 17, 2011 at 8:02 AM · No Comments

CDER Director Dr. Janet Woodcock will keynote workshop, modernized standards to have broad patient, industry impact

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 diphenhydramine-two very commonly used OTC ingredients-the 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tests where no tests exist and/or incorporating modern analytical techniques and technologies for those that are outdated by today's scientific standards.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 Pharmacopeia-National Formulary (USP-NF). Drug and ingredient manufacturers marketing products, including OTC products, in the United States are required by law to adhere to existing USP-NF 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), diphenhydramine (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 medicines-starting with those that are most widely used-all the more critical."

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