PCI affirms commitment to serialisation following FDA’s enforcement delay

PCI Pharma Services has confirmed its ongoing commitment to serialisation in response to the US Food and Drug Administration’s (FDA’s) delay on the enforcement of the Drug Supply Chain Security Act (DSCSA).

The FDA announced a delay in the enforcement of the new regulations by a year, which was welcomed by many in the pharmaceutical manufacturing sector. Despite vast amounts of resources being implemented to prepare for the DSCSA, there has been widespread concern regarding readiness for the November 2017 deadline.

“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,” asserted PCI president and CEO Bill Mitchell. “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.”

The company announced a significant investment in February through the expansion of its global serialisation offering. This investment tripled the capacity of the company’s global supply network in advance of the DSCSA deadline.