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.
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