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UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).
On Sep. 25, 2017, UPS revealed a new system to help healthcare companies better synchronize and share information for the pharmaceutical supply chain in the United States, as required by the Drug Supply Chain Security Act (DSCSA).
Passed in 2013, the law requires the application of serialization, enhanced traceability, and data reporting to help secure the drug supply chain and increase consumer safety. Under the law, US drug manufacturers and life science organizations must produce and communicate a unique, standardized numerical identifier for each package or homogenous case for each sellable unit of prescription drugs. Starting from the manufacturer to pharmacy or health care provider, every drug product transaction along the supply chain will need to be verified, documented, and authenticated in compliance with DSCSA.
According to the company, the system’s functional capabilities include: verification and authentication of serial numbers; data repository to meet the six-year data retention requirement; scanning and identification of bar codes and management of levels of aggregation; and tracing individual packages back to original cartons and pallets.
“The DSCSA is a complex yet important law to standardize the patch work of various state laws so that all supply chain stakeholders are better equipped to help secure the pharmaceutical supply chain. It will also allow for better performance of existing supply chain processes, such as managing recalls,” said Tim Bishop, UPS manager of healthcare compliance, in a company press release. “Our system is a smart conduit on information-sharing and data flow that will help secure the drug supply chain and trace the movement of pharmaceuticals.”
After Nov. 27, 2017, under DSCSA, wholesalers are not allowed to accept drug packages without a serial number. Although FDA recently published a draft guidance indicating it would use enforcement discretion for this requirement until November 2018, the requirement is currently in place, and industry compliance is expected. By 2019, wholesalers can only accept returned product for redistribution if the product can be associated with corresponding track-and-trace documents, and if it can verify the product identifier. By 2023, all systems must be in place to track individual drug packages back to the original manufacturer or repackager.