The Food and Drug Administration (FDA) is responsible for regulating a large number of products which include foods, pharmaceuticals, biologics, medical devices and cosmetics.   A large portion of the forensic evidence submitted to the FDA's Forensic Chemistry Center (FCC) for analysis includes suspect counterfeit products.  The regulated products which are impacted the most by counterfeiting include pharmaceuticals, medical devices and cosmetics.  In some cases, the pharmaceutical products have been found to contain the active pharmaceutical ingredient (API) found in the innovator (authentic) product. In other cases either no API or a substituted API has been observed.  In counterfeit cases where the proper API has been present, the overall formulation of the product was different than that of the innovator (authentic) product. In still other instances involving an online order a completely different product was sent to the individual.The FCC's analysis of suspect counterfeits requires a multidisciplinary approach to provide answers to case related questions, specifically identity and source of the counterfeit product.  This multidisciplinary approach includes but is not limited to the use of chromatographies (GC and HPLC) with mass spectrometric, ultraviolet and chiral detection, light microscopy, image analysis, elemental analysis (ICP-AES and/or ICP-MS) and infrared (IR) and Raman spectroscopy.This presentation will include  information from actual case studies involving counterfeit drugs, methods used and details of analytical approaches.

Pharmaceutical forensics: The use of a multidisciplinary approach in the detection of counterfeit pharmaceuticals

244th National Meeting (2012)

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