FDA Virtual Public Meeting on Enhanced Drug Distribution Security

The FDA is announcing a virtual public meeting to discuss enhanced drug distribution security at the package level.

The virtual public meeting will be held on November 16, 2021, from 9 a.m. to 4 p.m. (ET). This meeting will provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023.

Public Participation

Participants should register for this meeting before October 26, 2021. Stakeholders may submit comments to the public docket for this public meeting.

If participants wish to make verbal comments during the public comment portion of the meeting, they should submit the request form available on the Eventbrite registration page.

On what topics is FDA requesting comment?

  1. FDA requests that stakeholders submit comments responding to the following questions for one or more of the topics listed below.
  2. How is implementation of the 2023 enhanced system requirements progressing for your organization?
  3. What challenges is your organization facing?
  4. Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
  5. Are there areas in which FDA could provide more clarity?

Additional Topics:

  1. Enhanced Drug Distribution Security
  2. System Structure
  3. Enhanced Product Tracing
  4. Gathering of Relevant Product Tracing Information
  5. Enhanced Verification
  6. Trading Partner Readiness