Six-month serialization countdown in US: Think strategy and lead times, says CPO
May 26 marked six-months until the drug supply chain security act (DSCSA) enforcement deadline in the US, after which all market authorization holders (MAHs) and contract manufacturing organizations (CMOs) must be compliant.
The original DSCSA deadline was set for 2017, but the US Food and Drug Administration (FDA) offered a one-year reprieve – until November 26, 2018 – to manufacturers who had not yet assigned a product identifier to each package of prescription drugs.
With just six months left until deadline, contract packaging organisations (CPOs) Wasdell Group and Tjoapack have urged manufacturers – that are yet to implement track & trace systems – to do so, and quickly.
“With six months to go until the US DSCSA enforcement day, companies should really have already implemented a clear strategy for compliance,” said Wasdell Group’s director of regulatory affairs, Colin Newbould.
“Those who have not will now be struggling to acquire the necessary equipment and delivery lead times, which will inevitably get longer in the last-minute rush,” he added.
The UK-headquartered CPO advised firms to consider how long it will take to test packaging solutions, including extra time if changes are required. “For example, cartons will need to have unvarnished areas added to cater for new lines of text such as GTIN, batch number, expiry dates, serialised data and 2D data matrices,” said Newbould.
“Tamper evidence measures also adds a level of complexity…[and] packages that include braille will need to be adapted to cater for these systems,” he added.
Dutch CPO Tjoapack similarly urged manufacturers that were not yet DSCSA-compliant, to act.
“Companies looking to outsource their serialization requirements really must act now,” said director of corporate strategy, Dexter Tjoa.
“As the deadline gets closer, contract packagers will begin to get busier onboarding existing customers. New customers need to bear in mind that their partners will need at least four months to ensure approval of artwork and packaging protocols and design a suitable solution.
“Any further delays to engaging outsourcing partners could result in non-compliance and ultimately, delays to market and stock shortages,” he added.