Regulatory Focus™ > News Articles > FDA, USP Devices to Fight Counterfeit Medicines

FDA, USP Devices to Fight Counterfeit Medicines

Posted 11 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has developed a new tool it contends will assist the agency in its fight against counterfeit drug products, reports Med Page Today.

The device, known as the Counterfeit Detection Device Number 3, or CD3, emits 10 wavelengths of light over products, including the packages and certifying documents they come with. The wavelengths, comprised of both visible and invisible spectrums, alert inspectors to potential issues and likely forgeries, said Duane Satzger, director of FDA's Forensic Chemistry Center.

Though it isn't able to identify the specific problem, it alerts the inspector to the fact that, "There's a difference," explained Satzger. FDA reportedly has already deployed 50 of the devices into the field, reports Med Page Today.

The technology is the second major anti-counterfeiting announcement to be made in as many months. In an announcement in August 2012 by the US Pharmacopoeia (USP), the organization said it had developed a system it called PharmaCheck with help from the Bill and Melinda Gates Foundation. The device acts as a small, portable device capable of being used in the developing world to deliver stand-alone results. Current portable testing technologies require confirmatory testing in laboratories, explained USP, but their device is accurate enough to not require the secondary, expensive and time-consuming testing.

Unlike FDA's CD3 device, USP's PharmaCheck remains in a "proof of concept" stage of development.

Both FDA and USP said the development of their products were done in response to a surge in adulterated and counterfeit products, particular emanating from third-world markets. USP studies found, for instance, that 58% of all antimalarial drugs sampled in Guyana were of poor quality. FDA meanwhile said it was concerned about the increased number of products entering the country, particularly now that nearly 80% of pharmaceutical products originate from outside the US.

Read more:

Med Page Today - New FDA Device Helps ID Fake Drugs

Regulatory Focus - New Portable Anti-Counterfeiting Technology Promises 'Paradigm Shift'

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