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U.S. Department of Health and Human Services

Regulatory Information

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Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA

Title VII of the Food and Drug Administration Safety and Innovation Act – Drug Supply Chain; Standards for Admission of Imported Drugs; Registration of Commercial Importers and Good Importer Practices; Request for Comments

On July 12, 2013, the U.S. Food and Drug Administration (FDA) held a day-long public meeting on the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

Title VII gives FDA new authorities to address the challenges posed by an increasingly global drug supply chain. Today nearly 40 percent of finished drugs are imported and nearly 80 percent of active ingredients come from overseas sources.

The purpose of the July 12th meeting was to provide an overview of Title VII, discuss how FDA plans to implement it and hear public comment about those provisions that specifically address imported drugs and importers.  These provisions authorize FDA to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the United States. In addition, commercial importers must register with FDA and meet good importer practices. These authorities apply to both human and animal drugs.

For more information on the public meeting, please see the following:

View the webcast