OTC/Rx Industrial Drug Test Standards to get a makeover

Standards group teams with regulatory and OTC association to revamp outdated tests that measure quality, purity and strength of drugs

ROCKVILLE, Md. — The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.

The working relationships with FDA and CHPA fit into the group’s overall update initiative. The work will begin with a focus on an initial list of priority medicines and ingredients identified by the FDA. The U.S. Pharmacopeia—National Formulary provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by the FDA in the United States. USP standards are used in more than 130 countries. 

Testing procedures for the first few ingredients to be reviewed include the analgesic acetaminophen, cough suppressant dextromethorphan and antihistamine diphenhydramine. 

Several years ago, USP put in place a long-term effort to assess written standards for prescription and over-the-counter drugs published in the USP-NF compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP’s ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards. 

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