FDA Device

13 09 2012

On September 11, 2012 an article came out stating that the FDA has a new device that can detect counterfeit medications. Last Monday the FDA showed their Counterfeit Detection Device #3 or CD3, a hand-held device developed by FDA scientists that can be used in the field to detect counterfeit products and packaging.

It seems like a great tool! It is easy to use and you don’t need special training to operate it. Dr. Margaret Hamburg (FDA Commissioner) says “It is low cost compared to other analytical devices, operates with batteries, and requires minimal training to use. It allows for ‘real time’ comparisons with authentic drugs – and has already proven useful for identifying counterfeit drugs at our busy international mail facilities.”

It is already being used in 50 FDA laboratories along with border crossings and import centers. The machine emits 10 different wavelengths of light like ultraviolet and infrared imaging, which can be used on tablets and capsules, powders, and packaging (inks, papers and covert markings). What’s cool is that it can also detect products that have been tampered with such as products that are re-labeled or re-glued. The CD3 has been used to analyze nearly 100 counterfeit products including drugs like Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singulair, Plavix and Wellbutrin.

About 11% of our total imports in the US are drugs imported from other countries. Dr. Hamburg also says around 30% of the drugs on U.S. shelves and 30% of all medical devices come from overseas. This device is a great way to regulate their authenticity. The device costs about $1,000 and the new generation one is already being researched and put into the works. This makes me so excited that counterfeit drugs are being considered a top priority for the FDA!




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