Drugs

Public Workshop: Proposed Pilot Project(s) under the Drug Supply Chain Security Act

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. 
 
FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA.
 
The information gathered from the workshop and the public comments submitted to the docket will further inform FDA’s development of its pilot project program.  

Date(s):

April 5-6, 2016

Time:

Tuesday, April 5: 9:00 AM to 5:00 PM
Wednesday, April 6: 9:00 AM to 12:15 PM

Location:

FDA White Oak Campus
Building 31, Conference Center, Great Room (Rm. 1503), Sections B & C
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

Federal Register Notice:

Registration:

To request registration for the public workshop, provide your information including name, company or organization, address, telephone number, and email address below. You are not confirmed for registration for this workshop unless you receive a separate email confirming your registration.

Registration requests should be received by March 11, 2016. FDA is limiting workshop attendance due to limited space. FDA may limit the number of participants from each organization based on space limitations. FDA recommends that each organization determine who should register for the workshop to represent his/her organization. This will help ensure that the workshop will have broad and varied representation across the pharmaceutical distribution supply chain. Registrants will receive confirmation of participation for the workshop from FDA by March 18, 2016. There is no registration fee for the public workshop. There will be no onsite registration. If registration reaches maximum capacity, FDA will post a notice closing meeting registration for the workshop on this webpage. 

WE HAVE REACHED MAXIMUM CAPACITY. REGISTRATION FOR THIS WORKSHOP IS CLOSED.

 

Attendees:

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to:
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
If you need special accommodations due to a disability, please contact Daniel Bellingham (see Contact Information below) at least seven days in advance of the public workshop.

Contact Information:

Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: CDERODSIRpublicmeetings@fda.hhs.gov

Agenda and Discussion Topics:
Webcasting Information:

Portions of the workshop that were webcasted and recorded are available at the following links:

April 5, 2016

April 6, 2016

Submit Comments:

Submit electronic comments regarding the topics of the workshop to http://www.regulations.gov, or submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All submissions should include the Docket No. FDA-2016-N-0407. The submission deadline is April 21, 2016. (See the Federal Register Notice for more information.)

Other Resources:

FDA’s Drug Supply Chain Security Act webpage: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm

Title II of the Drug Quality and Security Act; The Drug Supply Chain Security Act:
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm

 

Page Last Updated: 04/15/2016
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