DSCSA Pilot Project Program
FDA’s Drug Supply Chain Security Act (DSCSA) Pilot Project 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 United States.
Under this program, FDA worked with the selected participants listed in the following table to explore and evaluate methods to enhance the safety and security of the drug supply chain. Participants reflect the diversity of the supply chain, including large and small entities from all industry sectors.
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 has been freely provided by the program participants.
The program has concluded, and the final program report is available to the public so that all supply chain stakeholders can benefit from the information gathered and lessons learned from FDA’s DSCSA Pilot Project Program. In addition, links to the individual pilot projects are provided in the following table. If you have specific questions about an individual pilot project, please contact the project lead.
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Pilot Project Program Participants
Questions and Answers: DSCSA Pilot Project Program
- What were the goals of FDA’s DSCSA Pilot Project Program?
The program was established to assist members of the pharmaceutical distribution supply chain with developing capabilities to identify and trace certain prescription drugs as they are distributed within the United States. The program goals included (1) identifying 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 (2) assessing the ability of supply chain members to (a) satisfy the requirements of section 582 of the FD&C Act; (b) 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 (c) exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner. - When did the DSCSA Pilot Project Program begin and end?
The program began on February 8, 2019. The average length of each pilot project was six months. The program has ended with the posting of the final program report and participants’ individual pilot project reports on FDA’s website.
- Did FDA pay for these pilot projects?
No, the participants were responsible for the funding and resources necessary to conduct their pilot projects.
- Which innovations were included in this program?
DA considered all viable technologies and methods from the pilot projects that would support enhanced product tracing and verification. This was an opportunity to test technologies or methods for enhanced drug distribution security requirements outlined in the law that will go into effect in November 2023.