FDA may offer counterfeit detection device to other bodies

CD3 imageThe US Food and Drug Administration (FDA) may consider making its recently unveiled handheld counterfeit detection device available to other organisations, such as overseas regulatory agencies, according to a spokesperson for the agency.

The new Counterfeit Detection Device #3 (CD3) has been patented and as reported in our previous article illuminates a sample with a variety of wavelengths of light, from ultraviolet to infrared.

"The approach is based on visual comparisons," the spokesperson told "The device illuminates a sample … and the surface response is visually observed. The user looks for differences between a known, such as an authentic pharmaceutical package or dosage form that is fluorescent, and an unknown or suspect sample."

She added that the device can also store a database of known authentic packaging/dosage form images, and can also be used to scan bulk active pharmaceutical ingredients (API) as well as "drum materials, plastic packaging materials, drum closure materials etc".

Should the device be offered to external organisations it remains unclear what the pricing would be. A figure of $1,000 has been published for the unit, but this only covers the cost of materials that go into its construction.

"The device was designed and built in FDA's forensic laboratory, so the labour costs are not included in that price," said the spokesperson. She also stressed the CD3 is being positioned as an add-on to the agency's currently deployed commercial scanners, which include Thermo Scientific's TruScan and TruDefender units.

CD3 imageMeanwhile, work is ongoing on a fourth generation of the device to "maximise the public health impact of the technology". 

Details of these updates are not yet being disclosed but we will keep tabs on the project and post updates when they become available.

The FDA developed the CD3 as part of its Analytical Tools Initiative (ATI), which was set up to explore "new or previously unused technologies for analysis and directed screening in the field and for rapid or high throughput analysis in the laboratory".

The agency's most recent five-year Strategic Priorities document notes that it is currently training for import personnel to detect suspected counterfeit drugs and/or packaging using the CD3, and is also training field staff on the use of a portable X-ray fluorescence (XRF) device capable of detecting toxic elements in imported products such as foods and dietary supplements.

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