The DSCSA Implementation and Readiness Efforts for 2023 Public Meeting

The purpose of this public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation. FDA requests that meeting participants come prepared to discuss the following topics:

• Stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements that will go into effect on November 27, 2023

• DSCSA standards for the interoperable data exchange of product tracing information for enhanced product tracing and verification

• FDA’s mechanism to request product tracing information as well as verification during investigations of suspect or illegitimate product or in response to a recall to support enhanced drug distribution requirements under section 582(g) of the Food, Drug, and Cosmetic Act

• Steps the pharmaceutical distribution supply chain has taken to build capacity for package-level tracing, including the ability of the health care system to maintain patient access to medicines, scalability of DSCSA requirements, and best practices

• Technical capabilities and legal authorities, if any, needed to establish interoperable, electronic product tracing at the package level

• General impact that the DSCSA requirements could have not only on public health including, patient safety and access to prescription drugs, but also stakeholders, in terms of costs, benefits, and regulatory burden

If additional topics are added, FDA will post these topics on the public meeting webpage prior to the meeting.

Registration

FDA may limit registration once the meeting capacity is reached.

***If you plan to attend both days, you must register for each day separately.***

General Session:

Individuals who wish to attend the general session of the public meeting must register by December 2, 2022, at the following link: [insert Eventbrite link]. Meeting information for virtual participation will be emailed by December 5, 2022, to those that registered.

Breakout Sessions:

Any person interested in participating in small group discussions, must register by November 28, 2022, following the instructions above, and request breakout session participation. There will be no same-day registration available for breakout sessions. FDA will organize breakout sessions based on registration and interest to help ensure varied stakeholder representation, including across the pharmaceutical distribution supply chain. FDA may limit the number of participants from each organization if interest exceeds breakout session capacity.

Request for Oral Presentations:

Any person interested in presenting during the public meeting must register by November 28, 2022, following the instructions above, and request to present. There will be no same-day registration available for oral presentations. FDA 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.

Online Attendance

This is a virtual event. The meeting link will be provided in a separate email to registered participants prior to the day of the meeting. This meeting will be available for online viewing via ZoomGov. We recommend using the Google Chrome web browser for an optimal meeting experience. Please ensure your display name in Zoom matches the name used to register for the meeting to ensure admittance to the meeting room and breakout sessions.

Video Recording

A recording of this meeting will be available a few weeks after the conclusion of the meeting and will be uploaded here.