- December 7 - 8, 2022
- - ET
- - ET
Location: This is a virtual event. The meeting link will be provided to registered participants prior to the event.
Registration is for this event is closed.
FDA will hold a virtual public meeting on DSCSA Implementation and Readiness Efforts for 2023. 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.
General Session: Individuals who wish to attend the general session of the public meeting must register by December 2, 2022, using the following registration link. Meeting information for virtual participation will be emailed by December 5, 2022, to those that registered.
Breakout Sessions: Individuals 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: Individuals 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.
- Federal Register: Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comment
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
|DSCSA Implementation and Readiness Efforts for 2023 Public Meeting Agenda||pdf (220.70 KB)|
|Oral Remarks from External Stakeholders||pdf (2.24 MB)|
|DSCSA Implementation and Readinesss Efforts for 2023 Public Meeting Slides||pdf (1.25 MB)|