Drugs

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 held a public workshop on May 8 and 9, 2014, entitled “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.”

This public workshop provided an opportunity 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.

During the public workshop, stakeholders provided input on the development of initial standards for the interoperable exchange of information between trading partners.

Agenda and Discussion Topics:

Comments:

To access the electronic comments regarding the topics of this public workshop please visit http://www.regulations.gov and search the Docket No. FDA-2014-N-0337.

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