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Article: FDA uses more than lab analysis of APIs to find fake drugs; excipient variation a major clue.(Counterfeiting)
- Article from:
- Validation Times
- Article date:
- April 1, 2009
- Author:
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ATHENS, GA -- Laboratory analysis is only one tool in FDA's armamentarium of weapons to combat counterfeiting, including excipient source and grade, an FDA chemist told the International Good Manufacturing Practice conference here last month.
Cheryl L. Flurer, Ph.D., of FDA's Forensic Chemistry Center in Cincinnati, OH, told the meeting at the University of Georgia College of Pharmacy about the agency's "multidisciplinary approach. to providing a large amount of information about authentic, counterfeit and diverted drug products.
She said the Forensic Chemistry Center's task is to determine: a) the presence of active ingredient(s); b) whether the product ...