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U.S. Department of Health and Human Services

Drugs

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FDA Counterfeit Drug Task Force Reports

In the United States, a relatively comprehensive system of laws, regulations, and enforcement by Federal and State authorities has kept the incidence of drug counterfeiting low, so that Americans can have a high degree of confidence in the drugs they obtain through legal channels.  In recent years, however, the FDA has seen growing evidence of efforts around the world by increasingly well-organized counterfeiters backed by sophisticated technologies and criminal operations to profit from drug counterfeiting. 

To respond to this emerging threat, FDA formed a Counterfeit Drug Task Force in July 2003. This group received extensive comment from security experts, Federal and State law enforcement officials, technology developers, manufacturers, wholesalers, retailers, consumer groups, and the general public on a very broad range of ideas for deterring counterfeiters. These comments reinforced the need for FDA and others to take action in multiple areas to create a comprehensive system of modern protections against counterfeit drugs. FDA discussed these ideas, and considered alternatives and criticisms at its public meetings, to develop a comprehensive framework for a pharmaceutical supply chain that will be secure against modern counterfeit threats.

The steps described in the Task Force report and updates are intended to further secure the safety of the U.S. drug supply.