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PCI Reinforces Ongoing Commitment to Serialization in Response to Delayed Enforcement of FDA Deadline

PCI Pharma Services (PCI) has affirmed its position relative to the delayed enforcement of the US Food and Drug Administration (FDA)’s Compliance Policy for ‘Product Identified Requirements Under the Drug Supply Chain Security Act’ (DSCSA).

Last month, the FDA gave the pharmaceutical supply chain a further year to prepare for the DSCSA requirements, announcing a postponed deadline of November 2018 by when 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.

Our clear response to the delayed enforcement reinforces our position as the market leading pharmaceutical outsourcing services provider and the strength of our ongoing commitment to Serialization.

Commenting on our commitment to the industry’s Serialization effort as market leader, PCI President and CEO Bill Mitchell said: “PCI is absolutely dedicated to maintaining our position at the forefront of the Serialization initiative and providing our clients with an industry-leading customer experience. We are committed to the Serialization industry initiative and are forcefully moving forward 100 percent with no plans to slow down our Serialization 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.

We have been at the forefront of Serialization adoption and implementation, actively serializing commercial medicines for more than five years to a variety of established and emerging global commercial markets. This long-term strategy has ensured that we have second-to-none Serialization experience and expertise to support our clients.

In February, we announced a significant investment in expanding our global Serialization offering, tripling our capacity across our 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 Serialization expertise. we have grown our dedicated Serialization department to more than 30 associates and will realize Serialization readiness on over 80 individual lines.

July 31, 2017


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