The Food and Drug Administration has started accepting applications to develop a system to identify and trace certain drugs as they’re distributed within the U.S.
The U.S. Food and Drug Administration has started accepting industry applications for a pilot program to develop an electronic system that will identify and trace certain drugs as they’re distributed within the U.S.
Development of the pilot program was authorized by the 2013 Drug Supply Chain Security Act (DSCSA). The legislation calls for completing the system by Nov. 27, 2023.
Participation in the DSCSA Pilot Project Program is voluntary and open to both large and small companies involved in the pharmaceutical distribution supply chain, including manufacturers, repackagers, wholesale distributors and dispensers. These participants will propose one to two individual projects that support the pilot’s objectives, FDA said.
“The 2023 system has the potential to reduce diversion of drugs distributed domestically as well as help deter counterfeit drugs from entering the supply chain,” FDA said.
“The pilot program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA,” the agency added.
The FDA will accept pilot participation applications through March 11. For more details, access the Federal Register notice.
FDA starts drug supply chain security pilot
