FDA Seeks Help in Developing Pilot Projects to Examine Supply Chain

April 20, 2016

The FDA wants help developing pilot projects that evaluate ways to secure the pharmaceutical supply chain.

The agency is asking stakeholders — including manufacturers, repackagers, wholesale distributors and dispensers — to comment on three topics to help shape these pilots. These topics address the use of product identifiers for tracing; methods for enhancing technical capabilities of the supply chain; and identification of ways to implement requirements established by the 2013 Drug Supply Chain Security Act.

The DSCSA outlined steps intended to build an interoperable system by Nov. 27, 2023 that would identify and trace certain prescription drugs distributed in the U.S. The notice comes roughly two months after the agency announced a workshop slated for April 5 to 6 to obtain feedback on potential pilot projects to evaluate track and trace systems.

To read the notice, visit: www.fdanews.com/04-14-16-track.pdf.