The U.S. Food and Drug Administration is announcing a day-long public meeting on July 12, 2013 to discuss how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
Title VII gave 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 is 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. Under Title VII FDA is authorized 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… Keep Reading…
Article Source: : SC Public Admin