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U.S. Department of Health and Human Services

Drugs

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Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.”

This public workshop is intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs, in addition to the feasibility of establishing standardized documentation to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.

Discussions at this public workshop may also include current practices and suggestions for the exchange of information between supply chain stakeholders to provide, receive, and terminate notifications, and how trading partners should respond to requests for verification of suspect drug product, and respond to requests for information from FDA or other appropriate Federal or State officials in the event of a recall or for the purpose of investigating a suspect or illegitimate drug product.

The public workshop will allow input from interested stakeholders on the development of initial standards for the interoperable exchange of information between trading partners.

Date(s): May 8-9, 2014
Time:9:00 a.m. to 5:00 p.m.
Location:FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Conference Center, the Great Room (Rm. 1503)
Silver Spring, MD 20993-0002
 

Registration:

As of April 22, 2014, FDA has closed registration for the workshop. We have reached the maximum capacity. On-site registration the day of the workshop will not be available.

 

Attendees:

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

If you need special accommodations due to a disability,please contact Connie Jung (see “Contact,” below) at least seven days in advance of the public workshop.

 

Contact Information:

Connie T. Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: drugtrackandtrace@fda.hhs.gov.
 

Agenda and Discussion Topics:

 

Webcasting Information

Recorded portions of the workshop that were webcasted can be accessed using the following links:

 

 

Submit Comments:

In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting comments on all aspects of the public workshop topics.  The submission deadline is June 9, 2014. Submit electronic comments regarding the topics of the workshop to http://www.regulations.gov, or submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  
 

It is only necessary to send one set of comments.  Identify comments with docket number FDA-2014-N-0337. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
 

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