FDA postpones DSCSA compliance for one year June 30, 2017

November 2018 becomes the deadline day for serializing pharma packages


It’s doubtful that there was a huge sigh of relief through US pharma land with the June 30 announcement—because the majority of pharma manufacturers have already taken steps toward meeting the Nov. 27 compliance deadline, even if they would not be 100% compliant by that date. But some manufacturers, and a considerable number of contract packagers (who perform packaging functions for multiple clients, and thus have a somewhat more complicated compliance strategy) now have some breathing room to continue their upgrading efforts. Perhaps the most relieved of all is FDA itself, which has been running behind in issuing guidances to industry on a variety of DSCSA compliance details (and in fact, the new guidance includes a paragraph promising some of that guidance eventually… Keep reading 

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