Earlier today, FDA published guidance, for immediate implementation, effectively delaying the effective date of the product tracing requirements for manufacturers, wholesale distributors or repackagers until May 1, 2015. This guidance appears to be a continuation of FDA’s efforts to address industry’s concerns about the implementation of the DSCSA product tracing requirements that are effective January 1, 2015.
It is unclear whether the ghosts of FDA past, present or future had anything to do with today’s announcement, but this Dickens-esque change of heart should ensure the product tracing requirements do not cause supply chain issues or drug shortages.
As a result of this guidance, manufacturers, wholesale distributors, and repackagers will have until May 1, 2015 to implement a process for providing and capturing transaction information, transaction histories and transaction statements. This guidance does not have much impact on dispensers who are still required to capture, and if necessary, provide this information beginning on July 1, 2015.