DSCSA Stabilization Period Midway Checkpoint
PDG-FDA Joint Public Meeting
June 17, 2024 12:30pm - 5:30pm | June 18 10:00am - 4:00pm | Washington, DC
The Partnership for DSCSA Governance (PDG) and the Food and Drug Administration (FDA) will hold a joint public meeting on DSCSA implementation and stabilization efforts on June 17th and 18th in Washington, DC. This hybrid in-person/virtual meeting will serve as a checkpoint midway in the stabilization period, affording industry, FDA, and other stakeholders an opportunity to share stabilization progress that has been made, stabilization activity that remains, and areas of remaining concern. The meeting will provide diverse and representative stakeholder groups, including FDA, an opportunity to share information that will support all stakeholders in efficiently executing the remaining steps needed to achieve enhanced product tracing together, including opportunities to expand upon insights shared and learned through FDA’s Request for Information, Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act and industry progress that PDG has captured.
Background: The Drug Supply Chain Security Act (DSCSA) required drug manufacturers, wholesalers, dispensers, and repackagers to implement secure, electronic, interoperable systems and process for enhanced product tracing by November 27, 2023. In August 2023, FDA published its Compliance Policy, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act, which established a 1-year stabilization period. This stabilization period is intended to afford trading partners the necessary flexibility to maintain patient access to medicines while the industry undertakes necessary actions to mature and stabilize their interoperable systems and processes.
Meeting Logistics:The meeting will be held from June 17, 2024 from 12:30pm – 5:30pm and June 18, 2024 from 10:00am – 4:00pm. Both in-person and virtual participation will be available. There is no fee to attend in-person or virtually.
In-Person Attendance: The meeting will be held at 601 New Jersey Ave. NW, Suite 350, Washington, DC 20001. Capacity is limited. Attendance will generally be allocated in the order registrations are received. However, in-person attendance may be reallocated to promote diversity and balance of perspectives represented. Your request to attend in person is not a guarantee of in-person attendance. In-person confirmations will be provided by email beginning May 14th. We do not recommend booking travel until you have received a confirmation email. All attendees are responsible for their own travel expenses, but a complimentary lunch will be provided.
Virtual Attendance:Virtual attendance is also available, subject to capacity limits, and the meeting agenda will be structured to promote a balanced opportunity for engagement among both in-person and virtual attendees. Attendance will generally be allocated in the order registrations are received. However, attendance may be reallocated to promote diversity and balance of perspectives represented. Meeting information for virtual participation will be emailed by May 31st.
Request for Oral Presentations: Individuals interested in presenting during the public meeting should indicate their request to present by checking the relevant box on the registration form above. There will be no same-day registration available for oral presentations. We will strive to accommodate requests for oral presentations. Individuals and organizations with common interests are encouraged to consolidate or coordinate their presentations and may submit a single request to present. Time allotted for each presentation will depend on the number of requests received and may be limited. Presentation confirmations will be emailed by May 31st.
Contact: For questions regarding this joint public meeting, please contact [email protected].