Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act

FDA held three public meetings entitled “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).” These public meetings gave members of the drug distribution supply chain and other interested stakeholders an opportunity to discuss strategies and issues related to the enhanced drug distribution security provisions of the DSCSA.

Dates	Topics
August 23, 2017	Supply chain security in 2023 Enhanced drug distribution security needs
December 5-6, 2017	Electronic interoperability Standards for data exchange Data architecture Aggregation and inference
February 28, 2018	Further refinement of enhanced drug distribution security needs Building capacity for a unit-level system

Summary

Public Meeting Series: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA)August 23, 2017, December 5-6, 2017 and February 28, 2018

Federal Register Notice

Enhanced Drug Distribution Security under the Drug Supply Chain Security Act; Public Meetings; Request for Comments: Docket No. FDA-2017-N-3857.

Agenda and Meeting Materials

Information for the February 28 meeting:

• Final agenda (PDF - 26 KB)
• Discussion topics (PDF -  73 KB)
• Concepts and terminology (PDF - 62 KB) 
• Presentation slides (PDF - 426 KB)

Information for the December 5-6 meeting:

• Final agenda (PDF - 48 KB)
• Discussion topics (PDF - 53 KB)
• Concepts and terminology  (PDF - 56 KB)
• December 5 presentation slides (PDF - 371 KB)
• December 6 presentation slides (PDF - 186 KB)

Information for the August 23 meeting:

• Final agenda (PDF - 24 KB)
• Discussion topics
• Presentation slides (PDF - 255 KB)
• Concepts and terminology

Webcast Links

The February 28 meeting recordings are available at the following links:

• Part 1: https://collaboration.fda.gov/p3nv8v6vfu6/
• Part 2: https://collaboration.fda.gov/p6li06ct26f/
• Part 3: https://collaboration.fda.gov/p1ckfcuh6gl/
• Part 4: https://collaboration.fda.gov/p4ipg44pjdj/

The December 5 meeting recordings are available at the following links:

• Part 1: https://collaboration.fda.gov/p7sqtwr5ff5/
• Part 2: https://collaboration.fda.gov/p3mg6zykiyu/
• Part 3: https://collaboration.fda.gov/p6inwqfw7qe/

The December 6 meeting recordings are available at the following links:

• Part 1: https://collaboration.fda.gov/p83dnq1usg8/
• Part 2: https://collaboration.fda.gov/p1182gyax4s/
• Part 3: https://collaboration.fda.gov/p7ougl0ltg0/
• Part 4: https://collaboration.fda.gov/p7xcq14yhko/ 

The August 23 meeting recordings are available at the following links:

• Part 1: https://collaboration.fda.gov/p68du06d1v8/
• Part 2: https://collaboration.fda.gov/p1q1bpjm1ih/
• Part 3: https://collaboration.fda.gov/p8bvwuqyahl/
• Part 4: https://collaboration.fda.gov/p3x30hu0pwm/
• Part 5: https://collaboration.fda.gov/p527a5r0clc/
• Part 6: https://collaboration.fda.gov/p6dp8wr8zy2/

Submit Comments

Submit electronic comments regarding the topics of the meeting to http://www.regulations.gov, or submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions should include the Docket No. FDA-2017-N-3857. See the Federal Register Notice for the specific deadline for submission for each meeting.

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Summary Public Meeting Series

Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA) August 23, 2017, December 5-6, 2017 and February 28, 2018(PDF - 40KB)