FDA’s DSCSA Pilot Project Program is intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.

Under this program, FDA is working with the selected participants listed below to explore and evaluate methods to enhance the safety and security of the drug supply chain. Participation reflects 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. 

When the program concludes, FDA will make a final program report available to the public so that all supply chain stakeholders can benefit from the information gathered and learned from FDA’s DSCSA pilot project program.

See the program announcement and the public workshop on the proposed pilot project(s) under the DSCSA for more information.

Selected program participants

Questions and Answers: DSCSA Pilot Project Program 

1. When will FDA’s program begin and end? 

The DSCSA Pilot Project Program began on February 8, 2019. Selected participants will begin their pilot projects by early August 2019.  Many of the pilot projects will last up to six months.  The program will end after the pilot projects are completed and FDA issues a final program report.

2. Is FDA paying for these pilot projects? 

No, the participants are responsible for the funding and resources necessary to conduct the pilot project.

3. What innovations will be included in this program? 

FDA is open to considering all viable technologies and methods from the pilot projects that will support enhanced product tracing and verification.  DSCSA has been in effect for several years and authorized trading partners in the drug supply chain are expected to have the appropriate systems and processes in place.  As new requirements will go into effect over the next 4 years, this is an opportunity to test technologies or methods for enhanced requirements outlined in DSCSA for 2023.

4. What is FDA looking for from this pilot project program? 

FDA previously held a public meeting in April 2016 to discuss proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participants will test new technologies, processes, or methods that can help spur greater accountability and improve the ability to trace prescription drugs at every point in the supply chain. 

5. What is the benefit of being part of FDA’s DSCSA Pilot Project Program? 
The program is a means for FDA and stakeholders to share learnings and information obtained from the pilots in an open way to further inform the enhanced system that goes into effect in 2023. When the program concludes, FDA intends to issue a final report and post it on our website. That report will include:

• the names and industry sector(s) of the pilot project participant(s);
• the pilot project’s objectives and evaluation methods;
• the duration of the pilot project; and
• the key findings and lessons learned from the pilot project. 

6. Will FDA disclose commercial confidential or proprietary information that is submitted as part of the program?   

No, 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 submitted to us in the program will not be disclosed publicly.  This will include confidential sales information, customer and supplier names, contractor and consultant names, and business plans.  However, there is no guaranteed protection.  FDA may be required to give this information to Congress or to a court, but we would try to limit disclosure as much as possible.    

7. What types of products can be included in the pilot projects?

The Pilot Project Program includes products considered to be drugs under the DSCSA, including brand-name and generic medicines. Donated, recycled, reclaimed, or otherwise previously dispensed medicines are out of scope of the pilot project program and present challenges under DSCSA requirements.

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