Up until recently, the deadline for pharmaceutical companies and contract manufacturers to meet serialization regulations regarding assignment of product identifiers to packages was November 26 of this year. Now the FDA has made the decision to push this date back to November of 2018, a one year delay. Many industry representatives feel this delay indicates that manufacturers in both the U.S. and Europe simply aren’t prepared, perhaps stragglers who haven’t yet begun efforts toward serialization.
Dexter Tjoa of Tjoapack, a leading contract packer for the biotec, pharmaceutical, and medtec industries in the Netherlands, said in reports that a serialization program requires about 18 months to implement, on average, so for those companies who haven’t begun serialization efforts, there is no guarantee these companies will be prepared by the new deadline. Given the new enforcement date is only 16 months away, contract manufacturers may be pushing the limits.
Staffan Widengren of Recipharm, a pharmaceutical CDMO based in Sweden, expressed his concern that some CMO’s would not meet the 2018 enforcement date. Widengren said in reports that “The announcement that the DSCSA deadline will be extended is a reflection on the lack of readiness among many contract manufacturers for new serialization requirements not only in the U.S., but Europe.” DSCSA is the Drug Supply Chain Security Act. Widengren said unless CMO’s make serialization a priority, they may not be ready, even with the extra time given by the FDA.
On the other hand, many pharmaceutical companies and contract manufacturers are prepared for the 2017 deadline. For those who have prioritized serialization and are on track, Tjoa said it is important they not become complacent and continue projects as planned. Widengren encourages those who are ready to view the extension as an opportunity to add additional value to their offerings and enhance their business strategy.
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