TraceLink Gets FDA Approval for Participation in the Pilot Project Program

The company’s pilot project focuses on an interoperable blockchain network solution and digital recalls across a supply network.


Under the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) was directed to create the Pilot Project Program to help develop an electronic, interoperable system to identify and trace prescription drugs as they are distributed within the United States.


TraceLink is one of the latest companies to receive approval from the FDA for participation in the Pilot Project Program. The company’s pilot project includes two different workstreams intended to enhance patient safety and increase network connectivity: an interoperable blockchain network solution and digital recalls across a supply network.


The blockchain workstream is designed to create a network of pharma industry stakeholders across the entire supply chain that will help to evaluate the use of blockchain technology for meeting the transaction information gathering requirements of the Drug Supply Chain Security Act (DSCSA). TraceLink will use its Trace Histories blockchain solution as a starting tool for the development of an open, interoperable network for the industry. Notably, Trace Histories was purpose-built for standardization to support interoperability across blockchain and non-blockchain networks.


The digital recalls workstream will investigate current recall verification systems and notification processes to determine the most effective network solution. To do so, TraceLink will use lot-level and serialization data on a digital supply chain network. The goal is to identify a network approach that can replace the highly inefficient and largely manual and individual processes used by companies today. Participants in the workstream will evaluate methods for exchanging information on a network and coordinating supply chain partners so that recalled products do not ever reach patients.



Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.