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How counterfeit pills enter the market
One would not expect it possible for counterfeit drugs to enter the US market due to the FDA's Pedigree system. The FDA defines pedigree as a statement of origin that identifies each prior sale, purchase, or transfer of a drug, including transaction dates plus the names and addresses of all involved parties.
A drug's pedigree assures that all ensuing pill transactions have a chain of custody all the way back to the company that produced the pills. However, if there is a way to game the system, bad guys will find and leverage it. One recent example was profiled in this FiercePharma Manufacturing blog post, "The U.S. has gotten guilty pleas out of a Texas couple who ran a fake-drug wholesaling business that sold nearly 60 million dollars' worth of drugs obtained off the street."
The wholesaling scam was lucrative for the couple to the tune of 14 million dollars profit. To sell real, but illegally obtained pills and counterfeit pills, the couple employed a front business in order to create provenance. Next, the illegal and or counterfeit pills were moved to a facility where the pills were packaged, provided fake pedigrees, and ultimately sold to pharmacies.Read More...
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