USP to Update Quality Standards for Widely Used Medications

April 1, 2011 1:53 PM Topics: Over the counter and Prescriptions

United States Pharmacopeial Convention (USP) will partner with Food and Drug Administration (FDA) and the Consumer Healthcare Products Association to update quality standards for widely used medications and ingredients. So that test procedures will be revised as needed to reflect scientific advances, the long-term plan will assess written standards for prescription and over-the-counter (OTC) drugs published in the United States Pharmacopeia-National Formulary (USP–NF) compendia. In addition, USP has made an ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards.
FDA has identified an initial list of priority medicines and ingredients. Margaret Hamburg, MD, commissioner of food and drugs, noted at the USP Convention meeting in April 2010, that updating test methodologies is a crucial task for USP and FDA due to documented incidents of poor-quality prescription and OTC products. A USP news release indicates that “FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophen – one of the highest-volume OTC drugs and one that is also used in many prescription medications.”

USP will consider all recommendations for updates and invites and encourages all stakeholders to provide input into the modernization initiative. USP seeks comments from manufacturers of products and ingredients included in the priority list of standards to be updated, and from the health care provider and consumer advocate communities.