Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop

 

The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Determination of System Attributes for the Tracking and Tracing of Prescription Drugs.’’ This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency’s goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.

Date(s):     February 15-16, 2011

Time:         9:00 a.m. to 5:00 p.m. 

Location:    FDA White Oak Complex
                 10903 New Hampshire Avenue
                 Bldg. 31, Room 1503
                 Silver Spring, Maryland 20993–0002

• Federal Register Notice (PDF - 55KB)
• Agenda (PDF - 22KB)
• Discussion Topics (PDF - 34KB)
• Workshop Summary (PDF - 63KB)
• Federal Register Notice - Reopening of Comment Period

 

Submitting Comments to the Docket

Comments can be submitted electronically to the docket at http://www.regulations.gov. The docket number is FDA-2010-N-0633. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number. Written or electronic comments must be submitted to the docket by June 22, 2011.

Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.

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