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PCI Responds to Delayed Enforcement of FDA Deadline

Company to continue to move forward on serialization readiness despite a one-year DSCSA deadline extension.

PCI Pharma Services (PCI) affirmed its position relative to the delayed enforcement of the U.S. 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 Nov. 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 resources devoted to the initiative, widespread concern lingered in the industry regarding readiness for the Nov. 2017 deadline. 

Commenting on PCI’s commitment to the industry’s serialization effort, 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 U.S. market as well as that of the European Union and emerging global markets.”

PCI says it has 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. 

In February, for example, PCI announced a significant investment in expanding its global serialization 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 serialization expertise. PCI has grown its dedicated serialization department to more than 30 associates and will realize serialization readiness on over 80 individual lines.

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