The Food and Drug Administration’s (FDA) Office of Regulatory Affairs, Forensic Chemistry Center developed the Counterfeit Detection Device (CDx) and methodology to screen for counterfeit pharmaceutical dosage forms and packaging in a non-destructive manner. Although traditional methods of detecting counterfeit products are effective, they require expensive, sophisticated and frequently bulky instrumentation, with testing performed in a laboratory by highly trained operators.
The CD3 is an inexpensive, rugged portable, hand-held, electronic device allowing ‘real-time’ rapid screening results in the field. It is simple to use and does not require special technical training. The CD3 is being used at a number of points of entry, where inspectors screen drugs, associated packaging, and cosmetics to identify counterfeit, falsified and unapproved products. The battery-operated device emits wavelengths of light from ultraviolet to infrared. The CD3 is used to examine tablets, capsules, powders, and packaging (inks, papers and covert markings). It has also demonstrated utility in examining products that have been tampered, re-labeled or re-glued. The CD3 is used to analyze numerous counterfeit products including drugs people take daily. The use of the device is being scaled to help improve the quality of medicines in areas with the greatest counterfeit drug problems, where bad products have been directly linked to adverse health consequences.
Nicola Tanieri, Food and Drug Administration
Diane Lirhus, Food and Drug Administration
Elizabeth MacCorkell, Food and Drug Administration
Marcus Fairconnetue, Food and Drug Administration
Mark Witkowski, Food and Drug Administration
Elsie Figueroa, Food and Drug Administration
Fred Fricke, Food and Drug Administration
Science Writers Symposium – CD3 Demo