Drugs

DSCSA pilot project program: how to participate

FDA is accepting requests to participate in the DSCSA pilot project program until March 11, 2019. The program is intended to assist drug supply chain stakeholders 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 will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the drug supply chain. This program is open to supply chain stakeholders who would like to apply. FDA will ensure that participation reflects the diversity of the supply chain including large and small entities from all industry sectors. When the program concludes, FDA intends to make a final program report available to the public so that all supply chain stakeholders can benefit from the information gathered and learned from the DSCSA pilot project program.

Stakeholders interested in participating in the DSCSA pilot project program may submit a request to DSCSApilotprojects@fda.hhs.gov and include the information about their proposed pilot project, including goals, objectives, timelines and evaluations methods. The specific information to include in the request is outlined in the program announcement.

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

Questions and Answers: DSCSA pilot project program 

  1. When will the program begin?

    FDA is accepting requests to participate in the DSCSA pilot project program until March 11, 2019. FDA’s program should not impact when participants start their pilot projects as long as projects are completed in the timeframe and are consistent with what was submitted in the initial proposal.

  2. Is FDA paying for these pilot projects?

    No, the participant will be 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 to be included in 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 systems and processes 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 that can help spur greater accountability and improve FDA’s ability to trace prescription drugs at every point in the supply chain. There are some ideas in Table 1 of the Federal Register notice, but the program will consider other proposals as well.

  5. What is required to perform a pilot project?

    Potential participants should read the federal register notice that was published on Friday, February 8 for instructions and the complete list of required information to be submitted to FDA by the deadline of March 11, 2019.

  6. I am involved in an ongoing pilot with my trading partners. Can we submit this pilot to FDA to be part of FDA’s pilot project program? 

    Yes. Existing or ongoing pilots will also be considered.

  7. What is the benefit of being part of FDA’s DSCSA pilot project program? 

    The pilot project 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. 
  8. 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. 

Page Last Updated: 03/06/2019
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