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
- Morning session: Title VII of FDASIA: Protecting the Integrity of the Global Supply Chain
- Morning session: Congressional, Industry and Public Interest Perspectives on Title VII
- Afternoon session: Provisions of Title VII Relating to Imports and Importers
- FDA's Globalization Strategy, John M. Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy
- Overview of Title VII and FDA’s Approach to Implementation, Susan S. de Mars, Senior Advisor, Office of Global Regulatory Operations and Policy
- Evolution in FDA’s Approach to Pharmaceutical Quality, Howard R. Sklamberg, Director, Office of Compliance, Center for Drug Evaluation and Research
- Industry Perspective on Title VII, Martin VanTrieste, Treasurer and Past Chair, Rx-360
- Public Interest Perspective on Title VII, Alan Coukell, Senior Director, Drugs and Medical Devices, The Pew Charitable Trusts
- Overview of Section 713 and Input Sought from Stakeholders, Jean McCue, Regulatory Counsel, Office of Compliance, Center for Drug Evaluation and Research, Section 713 Work Group Lead
- Overview of Section 714 and Input Sought from Stakeholders, Brian L. Pendleton, Senior Policy Advisor, Office of Policy, Office of the Commissioner, Section 714 Work Group Lead