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U.S. Department of Health and Human Services

About FDA

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Pilot Project Program under the Drug Supply Chain Security Act

Description: The FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Such projects shall build upon efforts, in existence as of the enactment date of the Drug Supply Chain Security Act (DSCSA) which was on November 27, 2013, to enhance the security of the pharmaceutical distribution supply chain, and consider any pilot projects conducted prior to enactment of the law. The project design will focus on 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. This project promotes patient safety by enhancing the security of the pharmaceutical distribution supply chain.

Briefing Status: Delayed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
1. Federal Register Notice announcing public workshop February 2016
Completed February 2016
2. Public Workshop April 2016
Completed April 2016
3. Establish Pilot Project Program June 2016
(October 2016)
Completed September 2017
4. Complete Pilot Project Program September 2017
(January 2018)
Not Yet Started TBD

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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