FDA Asks for More Input on Drug Supply Chain Traceability Pilot

The Food and Drug Administration seeks more input as it moves toward setting up its Drug Supply Chain Security Act traceability pilot for pharmaceuticals, it said (here). With FDA now set to submit the pilot for approval by the Office of Management and Budget, the agency is asking for comments on proposed information collection requirements related to the program, including requests to participate, recordkeeping and a series of reports on the results of the pilot. The pilot will inform FDA's development of a full pharmaceutical traceability system by 2023, the agency said. "FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information," it said. Comments are due Sept. 18. Separately, FDA also announced public meetings in August and December 2017 and in February 2018 to discuss drug supply chain security, including product tracing (here).