DSCSA Pilot Project Program
FDA’s Drug Supply Chain Security Act (DSCSA) Pilot Project Program has concluded, and the final program report is available so that all supply chain stakeholders can benefit from the information gathered and lessons learned. FDA considered all viable technologies and methods from the pilot projects that would support enhanced product tracing and verification. This program was an opportunity to test technologies or methods for enhanced drug distribution security requirements outlined in the law.
This program was established to assist drug supply chain stakeholders, including FDA, with developing electronic, interoperable capabilities that will identify and trace certain prescription drugs as they are distributed within the U.S. FDA worked with the selected participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. Participants reflected the diversity of the supply chain, including large and small entities from all industry sectors.
The program was established to assist members of the drug supply chain with developing capabilities to identify and trace certain prescription drugs as they are distributed within the U.S.
The program goals were to:
- identify the system attributes needed to implement the requirements of section 582 of the FD&C Act, particularly the requirement to utilize a product identifier for product tracing and verification purposes and
- assess the ability of supply chain members to satisfy the requirements of section 582 of the FD&C Act; identify, manage and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively; and exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner.
Selection into this program should not be interpreted as FDA’s position on an entity’s compliance with regulatory requirements or an endorsement of a particular technology, system or other approach used in the pilots.
FDA is bound by federal law and regulations to keep commercial confidential and trade secret information from public disclosure across all programs. Any such information that was submitted to us in the program has not been disclosed publicly, including confidential sales information, customer and supplier names, contractor and consultant names and business plans. All information in the individual pilot project links below has been freely provided by the program participants.
Contact the project lead with questions about a pilot project.