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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).
The operative FDA statement: FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to their packages and homogenous cases of product that are intended to be introduced in a transaction into commerce between November 27, 2017, and November 26, 2018.
But it could have been a different decision: there was some speculation that, given the distinctly un-customary practices of the Trump administration, an outright cancellation of the law’s provisions could have been attempted (overlooking the fact that it would need new legislation to do so). In the past, FDA has issued six-month delays of various kinds for the earlier DSCSA compliance deadlines. Or, one could recall the shocking California Board of Pharmacy decision in 2008—to delay what had been expected to go into force in that state from 2011 to 2015, a delay so long as to make a compliance program effort toothless (that decision also specified that California would defer to the federal government provided that action had been taken before the 2015 deadline, which did occur, through the passage of the Drug Supply Chain Security Act in 2013).
Some background: DSCSA specifies a timetable for taking staged actions between 2015 and 2023, leading up to a fully electronic system that enables each individual drug package to be uniquely tagged and to be tracked through distribution channels up to patient delivery. “Lot level” tracking went into place starting in 2015; individual package tracking was to occur in 2017 (this is the step now being delayed); and downstream parts of the supply chain—distributors, pharmacies, health systems—were to have their documentation programs in place in successive years, with all of it being fully digitized by 2023. Significantly, the June 30 FDA action did not move other deadlines a year back, which means there will be something of a crunch come November 2018.
Technically, the FDA announcement is a draft guidance; usual FDA practice is to put it out for comment for 60 days and then issue a final guidance. (Want to protest—or applaud—the delay? You can submit comments to https://www.regulations.gov )