FDA melamine test guidance
This article was originally published in The Tan Sheet
Executive Summary
FDA urges pharmaceutical manufacturers, suppliers and others to test certain ingredients for melamine contamination. In guidance posted Aug. 6, the Center for Drug Evaluation and Research recommends firms use liquid chromatography triple-quadrupole tandem mass spectrometry and gas chromatography/mass spectrometry to test 23 ingredients for the chemical. FDA says in a same-day press release that it "has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine," but recent melamine contamination problems with pet food and infant formula "underscore the potential problem" (1"The Tan Sheet" Dec. 1, 2008)
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A coalition of pharma industry groups, including the Consumer Healthcare Products Association and the Pharmaceutical Research and Manufacturers of America, requests FDA withdraw its final 1guidance on testing for melamine contamination in pharmaceutical products, which the agency issued in August. In a Sept. 9 2letter, the Coalition for the Monitoring of Melamine Adulteration says given the lack of "acute risk" from melamine in their products, FDA should reissue the guidance in draft form with a Q&A document and allow for a comment period. The coalition recommends FDA address supply chain integrity, rather than focus on specific adulterants. Industry also asks FDA to be more flexible about testing methods and eliminate the word "requirements." FDA acknowledged it is not aware of any melamine-contaminated drugs (3"The Tan Sheet" Aug. 10, 2009, In Brief)
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