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FDA Pilots Programs to Enhance Traceability


Published on July 30, 2020

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013. The requirements and compliance deadlines of the Act include Section 5851, establishing pharmaceutical traceability, wholesale distributor and third-party logistics standards and regulations.

The FDA has continued to refine portions of the DCSCA draft guidance that has included publication of final guidance for certain portions. Specific to the traceability and supply chain processes and Section 585, the FDA announced the undertaking of a pilot project in 2017, with a call for comments and pilot participants from the pharmaceutical industry. The purpose of the pilot program is to test new technology in the pharmaceutical manufacturing setting, seeking best practice processes for traceability systems. The Act is currently set for full adoption by 2023.

As the industry watches the progress of this significant initiative, this article offers a summary of the activities and outcomes that have taken place so far. The most recent action published by the FDA relating to the supply chain pilot projects was the 2019 reopening of industry comment period and request for information regarding the pilot projects, extending the comment period to June 28, 2022. We are watching eagerly for anticipated pilot program reporting in the months ahead.

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You might also like Full FDA DSCSA timeline

Source: (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),


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