Unlike counterfeit handbags, watches, or movies that one can buy from a street vendor, counterfeit pharmaceuticals present a real and imminent public health risk. How to prevent counterfeit pharmaceuticals from entering the consumer supply chain has challenged the United States Food and Drug Administration (FDA) and other regulators since the late 1980s. FDA has not yet successfully implemented final regulatory safeguards in this arena, leading some drug manufacturers to delay implementation of anti-counterfeiting measures. Drug manufacturers are taking a considerable risk, however, by waiting for FDA to overcome the complexities of broad-based regulation.
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