Project Summary

Traditional methods of detecting counterfeit products are effective but require expensive, sophisticated and frequently bulky instrumentation. To make this process more efficient, the Food and Drug Administration developed the Counterfeit Detection Device (CDx) and methodology to screen for counterfeit pharmaceutical dosage forms and packaging in a real-time non-destructive manner.

Project Team

Team Members
Nicola Tanieri, FDA
Diane Lirhus, FDA
Elizabeth MacCorkell, FDA
Marcus Fairconnetue, FDA
Mark Witkowski, FDA
Elsie Figueroa, FDA
Fred Fricke, FDA


Project Details

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.


Additional Information


Background

HHS Innovates is one of the ways we are building an innovative culture at the Department of Health and Human Services. HHS Innovates is a contest that recognizes and rewards action taken on good ideas. To date, HHS employees have submitted nominations of innovations for nearly 500 exciting new staff-driven innovative projects, and our employees have cast over 60,000 votes to select 42 finalists over seven rounds. This project is one of the finalists of HHS Innovates. Learn more about HHS Innovates.