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FDA Cautioning Industry on Looming Initial Track and Trace Deadlines

Jul 30th, 2014

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FDA is cautioning industry stakeholders that the initial implementation phase for the track and trace provisions in the Drug Quality and Safety Act (DQSA) is rapidly approaching, with interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015.

Beginning in January, these trading partners will be required to provide transaction information at each point that a finished product changes ownership, which needs to include a history of the ownership going back to the manufacturer, generally at the lot level.  Dispensers, however, will have until July 2015 to put the transaction systems in place.

Also by that date, all distributors, dispensers and third party logistics providers (3PLs) will need to be authorized to perform their supply chain functions through registration with FDA, and have systems and processes in place to verify the authenticity of the each of the products they handle.

[The story continues for subscribers beginning on page 2 and includes a review by a CDER official involved in DQSA implementation on: ● upcoming deadlines ● exemptions ● the progress of FDA to date on implementation plans, and ● stakeholder feedback from a recent workshop.  Nonsubscribers can get information on IPQ subscription/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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