June 20, 2013
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.
At the meeting, the public will have an opportunity to provide information and share views that will assist FDA in drafting regulations under these provisions.
- Date/Time: July 12, 2013, 9:00 a.m. to 5:00 p.m.
- Location: FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, the Great Room (Rm. 1503), Silver Spring, MD.
- Attendance and Registration: Attendance is free and will be on a first come, first served basis. Individuals who wish to present at the public meeting must register on or before July 5, 2013.
- Webcast: A live webcast of this meeting will be viewable on the day of the meeting. A video record of the meeting will be available at the same Web address for one year.
For further information, including information on the scope of public input requested, see the Federal Register Notice.
Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA[ARCHIVED]
- FDA Safety and Innovation Act Title VII-Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments