FDA Plans Pilot Projects for Drug Supply Chain Security Act

Under the Drug Supply Chain Security Act (DSCSA), FDA is required to establish pilot project(s) to “explore and evaluate methods to enhance the safety and security of [the] supply chain,” the agency noted in a request for proposals in July 2015. The agency recently awarded a contract to consulting firm USDM Life Sciences, who will work with DSCSA consultancy RC Partners and event management firm The Clarion Group. The three companies were designated to work together for approximately eight months to deliver and execute the FDA program for the pharmaceutical distribution supply chain. The project will include developing the structure of the pilot program, including a schedule and enrollment process for potential participants, and implementing and monitoring the pilot project.  

“Along with our strategic business partners, USDM Life Sciences and The Clarion Group, Inc., we’re eager to deliver a comprehensive pilot program that not only complies with pilot requirements for DSCSA, but also contributes to the FDA’s overall goal to improve patient safety,” Robert Celeste, founding partner of RC Partners and former GS1-US point person for the pharmaceutical industry, in a press release. 

Sources: RC Partners, FDA