I recently attended the FDA public workshop on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format” for the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27th 2013. Over 120 people participated in the public workshop including Manufacturers, Repackagers, Distributors, Dispensers, Industry Consultants and Solution Providers. The purpose of the public workshop was:
- To obtain information about current practices, research, and ideas on the interoperable 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.
- To discuss the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.
We broke out into discussion groups to provide feedback on several topics, and here are overviews of a few:
1. A review of Transaction Information, Transaction History, and Transaction Statement as defined in the DSCSA to discover if there were any specific issues or challenges related to the information that will be exchanged or if there were any clarifications needed. There were many issues brought up by each group including: