The FDA’s Forensic Chemistry Center (FCC) is responsible for providing rapid response and specialized analytical services for activities related to product tampering, chemical terrorism, and counterfeit products. The FCC processes suspected counterfeit products ranging from solid dosage forms to injectables, creams, ointments, patches and inhalers, which can cover active ingredients and excipients from elements, small inorganic and organic compounds to larger molecules such as peptides, proteins and monoclonal antibodies. Due to the breadth of regulated products that fall under FDA’s jurisdiction, the techniques, methods and instrumentation required to address these requests for analyses encompass areas of trace evidence, molecular and microbiology, atomic and molecular spectroscopy, mass spectrometry and others. The evaluation of print processes on product packaging materials and labeling, and the use of the Counterfeit Detection Device (CDx), have become invaluable initial assessment tools of the authenticity of a product. These rapid analyses are followed by a number of different techniques that are appropriate for the product of interest. For example, image analysis/profilometry is used to map tablet imprints, which can be compared to authentic products, to other counterfeits, and to the punches used to manufacture the tablets. Fourier-transform infrared spectroscopy is a key technique in determining the presence/absence of the expected active pharmaceutical ingredient(s) or principal component(s), and in providing information on the overall product formulation. Gas chromatography and/or liquid chromatography with mass spectrometric detection are additional tools that are used in determining active ingredients and contaminants. Elemental analysis and ion chromatography are utilized to characterize product formulations in injectable products in particular. This presentation will highlight many different techniques that are utilized to evaluate suspect pharmaceutical products, and will give examples of how those analyses are brought together to characterize counterfeits that have been identified at the FCC.

Determination of counterfeit pharmaceuticals at the FDA Forensic Chemistry Center

254th National Meeting (2017)

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