FDA Requests OMB Approval of Upcoming Drug Supply Chain Security Act Product Tracing Pilot

The Food and Drug Administration soon will launch a pilot program to test product tracing requirements in the Drug Supply Chain Security Act set to take effect in 2023, it said in a notice of its request for Office of Management and Budget Approval of the pilot’s information requirements. Under the pilot, FDA will assess the ability of supply chain members, including authorized manufacturers, repackagers, wholesale distributors and dispensers, to satisfy DSCSA Section 582 product tracing requirements; identify, manage and prevent distribution of suspect and illegitimate products; and “demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain,” FDA said. FDA hopes to conclude its pilot within one year of the start date to give it time to consider results before it implements an actual electronic product tracing system in 2023, the agency said.