Québec, May 15, 2019 – OPTEL has been chosen to participate in the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA) Pilot Project Program to help identify and trace prescription drugs as they are distributed within the United States.
Serialization and traceability companies selected for the project will test new technologies to develop an electronic, interoperable system to help improve the FDA’s ability to trace prescription drugs at every point in the supply chain, with an emphasis on the enhanced requirements for package-level tracing and verification that will go into effect in 2023.
“We are eager to demonstrate how our traceability systems and serialization expertise can help pharmaceutical organizations comply with the FDA’s DSCSA mandates, especially the aggregation requirements that take effect in 2023,” said Louis Turcotte, OPTEL’s Vice-President, Pharmaceutical.
“With three decades of experience and our exclusive ability to provide end-to-end traceability from raw material extraction all the way to the consumer, OPTEL is well positioned to offer the leading-edge solutions required to bring complete visibility to the entire supply chain.”
For the pilot project, OPTEL chosen to focus on interoperability and data/database/system issues and will demonstrate how its solutions can help companies overcome a myriad of supply chain track-and-trace business challenges, such as maintaining the integrity of serialized barcode information, data quality throughout the product life cycle, data access and control, and the ability of the system to record product status at all packaging levels.
To successfully complete the pilot and record its findings, OPTEL will partner with select North American manufacturers, wholesale distributors, and dispensers in the United States. OPTEL expects to wrap up its part of the project by January 2020 and complete the reporting component by the end of February 2020.
“The technologies used to drive OPTEL’s Intelligent Supply Chain solutions will allow many industries to benefit from actionable, real-time data to ensure the quality, integrity and authenticity of consumer products, help stop counterfeiting and reduce waste,” Turcotte said. “We are pleased that through this pilot program, the FDA may leverage our learnings and latest technologies to enhance the security of the drug supply chain in the United States so that all stakeholders can benefit.”
OPTEL, a leading global provider of vision inspection and traceability systems, is the only company with the ability to offer true end-to-end traceability—from raw materials to the end user. OPTEL provides cost-effective, turnkey solutions to ensure the quality and integrity of products, comply with legislation, help stop counterfeiting, reduce waste and secure patient safety.
Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in the United States, Ireland, India and Brazil, as well as employees worldwide.
For more information, visit www.optelgroup.com.
Marketing Lead, Pharma