The serialisation stragglers: industry concern for complacency
The draft policy states the FDA will not penalise manufacturers who do not assign a product identifier to each package of prescription drugs before November 26, 2018, offering a one year reprieve on the original November 26, 2017 deadline.
Contract manufacturing organisation Recipharm’s Staffan Widengren said he is concerned some CMOs will not meet the extended, 2018 deadline.
“The announcement that the DSCSA [Drug Supply Chain Security Act] deadline will be extended is a reflection on the lack of readiness among many contract manufacturers for new serialisation requirements not only in the US, but also in Europe,” Widengren said.
“The extra time should in theory allow companies to refine their requirements and timings and ensure the right systems are in place come the new deadline in 2018, however unless CMOs start to prioritise serialisation, my concern is that this will not be the case,” he told us.
Pharmaceutical packaging firm Tjoapack’s Dexter Tjoa also expressed concerns that despite the reprieve, some firms may struggle to implement regulations within the allocated time frame.
“It must be remembered that an average serialisation implementation program takes roughly 18 months – so for those who haven’t started yet, it is not guaranteed they will be ready for the November 2018 enforcement date either,” said Tjoa.
And for those on track?
Tjoa urged contractors on track for the 2017 deadline to continue implementation procedures as originally intended.
“I think it is important that manufacturers and CMOs/CPOs do not become complacent and continue their serialisation projects as originally planned,” said Tjoa.
Widengren encouraged firms prepared for the impending deadline to see the extension as an opportunity to improve business strategy.
“CDMOs [contract development manufacturing organisations] should see this extension as a positive thing and should use the time to ensure a comprehensive, tried and tested serialisation strategy is in place and that it is fully integrated across its business operations,” said Widengren.
“Of course, the deadline extension also gives CMOs that are leading the pack the opportunity to add further value to their offering by exploring the wider business benefits that can be achieved through implementing new systems and processes,” he told us.