FDA – Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA)

On July 20, 2017, FDA issued a Federal Register notice announcing that three (3) public meetings have been scheduled to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA.

Note that FDA is limiting public meeting attendance due to restricted space.  FDA may also limit the number of participants from each organization based on space limitations.  However, to permit the widest possible opportunity to obtain public comment, FDA is soliciting comments on all aspects of the public meeting topics.

Dates, meeting topics, and comment due dates are listed below:

Public Meeting Meeting Date/Time Meeting Topics Comment Period Closes
1 August 23, 2017

9:00am to 4:00pm EST

 

(Register by July 31, 2017)

· Supply chain security in 2023

· Enhanced drug distribution security needs

September 22, 2017
2 December 5-6, 2017

9:00am to 4:00pm EST

 

(Advance Registration: October 2-27, 2017)

· Electronic interoperability

· Standards for data exchange

· Data architecture

· Aggregation and inference

January 5, 2018
3 February 28, 2018

9:00am to 4:00pm EST

 

(Advance Registration: January 2-26, 2018)

· Further refinement of enhanced drug distribution security needs

· Building capacity for a unit-level system

March 30, 2018

 

All meetings will be held at FDA’s White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503A, Silver Spring, MD 20993

Refer to the Federal Register notice for additional information on meeting registration, parking, and security.  Materials for each public meeting will be posted on FDA’s website – refer to the Federal Register notice for details.

Portions of each public meeting will be recorded and webcast on the day of the meeting.  The webcast will be conducted in listening mode only – refer to the Federal Register notice for more information.

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