UPDATE: Track-and-Trace Enforcement Delayed

The FDA is delaying the enforcement of the November 27, 2017 Drug Supply Chain Security Act (DSCSA) deadline for manufacturers to place unique product identifiers on their packages.  The FDA draft guidance from June 30, 2017 provides some relief for those manufacturers struggling to prepare for the upcoming deadline.

There is no change to the requirement, but enforcement is being delayed.  Manufacturers that do not include the unique product identifiers on their packages starting November 27, 2017 are not in compliance.  However, the FDA does not intend to take action against these manufacturers before November 26, 2018 (a one year delay).  This delay does not impact any other aspect of the DSCSA implementation.

More information about Track-and-Trace can be found by the following this link:

http://phsirx.com/blog/track-and-trace-staggered-deadlines-may-lead-to-workflow-disruption

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