Pharma companies exporting to the US market who had their eye on the November 2017 deadline to comply with the US Drug Supply Chain Security Act (DSCSA), have got a welcome breather. A draft guidance on June 30 announced that enforcement of the serialisation compliance would be delayed by a year, though the DSCSA will roll out as scheduled this November 27. Companies exporting to the US will be still legally required to print a unique product identification code (equivalent to the barcode on all items in a supermarket) on all prescription units of sale and homogenous cases distributed within the US market but the authorities will not take action against those which are yet to put in place these systems.
The US FDA’s draft guidance document comes in response to the feedback from manufacturers and their trading partners ‘expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers.’ Stakeholders specifically described challenges with implementation of product identifier requirements due to a limited number of vendors with the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines. The second challenge related to capabilities and readiness of contract manufacturing operations.
Some of these concerns were discussed at ISPE’s Inaugural Pharmaceutical Serialisation Workshops held over May 8-9 where solution providers and pharma companies recounted experiences of first movers in the serialisation world, like Turkey and India. Speakers included regulators like Richard Andrews, Unit Manager, Inspectorate Operations, MHRA, UK and Connie Jung, PhD, RPh, Senior Advisor for Policy, FDA/CDER/OC, US. These discussions evidently convinced the authorities that this grace period would ‘minimise possible disruptions in the distribution of prescription drugs in the United States.’
But experts caution that this is still only a draft guidance, and this delay does not change their legal responsibilities post November 27, 2018. The draft guidance clearly states that, ‘a manufacturer must still validate any applicable transaction history and transaction information in its possession if the manufacturer has determined that a product in its possession or control is a suspect product or if the manufacturer receives a verification request from the FDA or an authorised trading partner that is in possession or control of such product.’ The same goes for repackagers, wholesale distributors, and dispensers who have products without identifiers post November 27, 2018.
Thus contract manufacturers will have to use this additional time wisely and ensure they are compliant at least by the first quarter next year. Industry sources warn that more stringent enforcement of the DSCSA can be expected post November 27, 2018, given the extra year of leniency. Clients who view serialisation not just as a regulatory diktat, but a strategic opportunity to glean more insights from the mammoth quantities of data generated during serialisation, will be best positioned to meet the deadline.