As Outsourcing-Pharma.com previously reported, the US Food and Drug Administration (FDA) recently published a draft guidance in which it explained enforcement of the Drug Supply Chain Security Act (DSCSA) will be extended until November 2018.
According Verify, a cross-industry, serialization and authentication solution company, its SWIFT serialization implementation process will enable Covis Pharma to implement necessary DSCSA compliance components.
“Even though the FDA recently extended the DSCSA product identification mandate, we’re seeing many pharma manufacturers like Covis move their serialization projects forward for a couple of reasons,” Michael Howe, CEO, Verify Brand told Outsourcing-Pharma.com.
“First, pharma companies must still comply with the parts of the DSCSA that take effect in November 2017,” he said.
Additionally, the FDA acknowledges that “stakeholders have described challenges with implementation of product identifier requirements due to a limited number of vendors that that have the expertise to provide solutions related to information technology systems for data management.”
“This puts pharma companies at risk of missing FDA deadlines if they choose a provider with limited experience and capabilities,” said Howe.
Covis has already integrated the Verify Platform’s standards-based EPCIS software throughout much of its supply chain partner network.