In efforts to protect the pharma supply chain, 2013’s DSCSA laid out a series of serialisation rules, with the second phase – the requirement to give unique serialisation numbers and bar codes to the smallest saleable unit of pharmaceutical products – coming into force today.
Drugmakers have been preparing for the rule for the past few years, including Swedish contract development and manufacturing organisation (CDMO) Recipharm which has invested over €40m ($48m) in serialisation equipment and technologies since 2016, and today announced a further two facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden are now compliant.
“Nine of our sites are ready and producing serialised products. Two sites will be ready shortly – Q1 2018 – and four sites will be ready during 2018,” Staffan Widengren, director corporate projects, Recipharm, told this publication.
“Recipharm is ready to meet the DSCSA requirements and on the whole, our customers that use us to manufacture their products for the US market are ready.”
But not all parts of the supply chain are as prepared, he continued, telling us in some cases the customer has had to “build a safety stock of unserialised products to bridge the gap until serialised products can be supplied. This is due to a number of factors, including the need to still connect to a repository for the delivery of serial numbers.”
Though the deadline has now passed, both marketing authority holders (MAHs) and CDMOs that are still not following serialisation requirement may be offered a reprieve after the US Food and Drug Administration (FDA) offered up a one year grace period, delaying enforcement until November 2018 “to provide manufacturers additional time and avoid supply disruptions” in draft guidelines earlier this year.
“FDA does not intend to take action against a repackager, wholesale distributor, or dispenser that engages in a transaction involving such product, except where a repackager’s transaction triggers an independent responsibility to affix or imprint a product identifier,” the guidance stated.
Widengren told us: “Recipharm has followed our plan for the serialisation of US products independent of the grace period. The majority of our customers that supply products to the US market still require serialised products from November 2017 as the legislation is now in force.”
No time to relax
Commenting on the passing of the deadline, Carlos Machado, serialisation director US at technology provider SEA Vision, said: “Companies that fail to comply with the regulations risk production downtime and loss of business in key markets. When you consider the potential impact on patients, the current situation is extremely worrying, with many small and mid-sized companies still struggling to meet the requirements.
And despite the FDA delaying active enforcement by a year, the pharma industry “cannot afford to relax.
“Serialisation is still presenting a serious challenge and must remain a priority over the next year," he said. "For those that are yet to introduce a solution, it is important that they recognize the enormity of the task still at hand, particularly if a lack of resource has delayed their preparations.”