The European Commission took a big step forward in protecting the interests of ethical drug manufacturers and the safety of the public with its Falsified Medicines Directive 2011/62/EC. There is an important distinction to make: Falsified drugs are not counterfeit drugs, which often contain no active ingredient at all. Rather, falsified drugs may contain substandard ingredients, or active ingredients in the wrong dosage. In some cases, they may be deliberately and fraudulently mislabeled with respect to identity and source, or possess fake packaging. Released for comment in 2011, the consultation phase for this directive ended in April 2012 and a planned adoption of the delegated act will be in force in 2013. The new legislation takes aim at manufacturers of active pharmaceutical ingredients (APIs) that are not compliant with good manufacturing practices (GMPs). The implications of the new directive go beyond API manufacturers and extend ultimate responsibility back to the drug manufacturer for GMP compliance. In addition, the onus is on the drug manufacturer to ensure that the API manufacturer is good distribution practice (GDP)-compliant. In the United States, there are no formal regulatory standards for good distribution practices.
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