FDA is announcing a public workshop regarding implementation of the Drug Supply Chain Security Act. The workshop, entitled “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format” on May 8 to 9 in Silver Spring, Maryland.
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.