The U.S. Food and Drug Administration is hosting a public workshop focused a critical part of the Drug Quality and Security Act. 

The “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format” workshop is designed for people to share information, tell current practices, research, and consider ideas on the feasibility of establishing standardized documentation.

Although 3PLs are not required by the DQSA to convey transaction information, transaction history, and transaction statement, manufacturers, wholesalers and dispensers will be required to do so effective Jan. 1, 2015.

This proactive approach by the FDA to ask for feedback before designing guidance is a welcomed one. IWLA consistently offers to provide feedback and resources to regulators, and hopes that this will serve as a successful example of how both groups can work together in designing guidance that brings conformity, safety and security. IWLA Washington Representative Pat O’Connor is representing IWLA during the May 8 & 9 workshop—more details to come. View the attached agenda and background documents for the workshop.