In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013.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.
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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Source: (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),