PCI commits to serialisation in response to delayed FDA deadline


PCI Pharma Services has affirmed its position relative to the delayed enforcement of the US Food and Drug Administration's Compliance Policy for Product Identified Requirements Under the Drug Supply Chain Security Act

Last month, the US Food and Drug Administration (FDA) gave PCI, the pharmaceutical supply chain, a further year to prepare for the Drug Supply Chain Security Act (DSCSA) requirements, announcing a postponed deadline of November 2018 by which, pharmaceutical manufacturers must include product identifiers on all prescription drug packages and cases.

The FDA announcement was widely anticipated and welcomed by key stakeholders across the pharmaceutical manufacturing sector as a necessary move for overall industry preparedness. Despite considerable resource being devoted to the initiative, widespread concern lingered in the industry regarding readiness for the November 2017 deadline.

PCI Pharma Services (PCI) have been at the forefront of serialisation adoption and implementation, actively serialising commercial medicines for more than five years to a variety of established and emerging global commercial markets. This long-term strategy has ensured that PCI have a second-to-none serialisation experience and expertise to support its clients.

Bill Mitchell, President and CEO at PCI, said: “PCI is absolutely dedicated to maintaining our position at the forefront of the serialisation initiative and providing our clients with an industry-leading customer experience.

We are committed to the serialisation industry initiative and are forcefully moving forward 100% with no plans to slow down our serialisation readiness despite the extended deadline to meet DSCSA requirements. We stand ready to support all our clients in providing safe and effective life-saving medicines for both the US market as well as that of the European Union and emerging global markets.

In February, the company announced a significant investment in expanding global serialisation offering, tripling its capacity across its global supply network in advance of the DSCSA deadline. The investment includes providing best-in-class equipment; a flexible and seamless data exchange and skilled staff teams with real serialisation expertise.

PCI has grown its dedicated serialisation department to more than 30 associates and will realise serialisation readiness on over 80 individual lines.

Sign up for your free email newsletter