As the pharmaceutical industry continues its adherence to the Drug Supply Chain Security Act (DSCSA) serialization requirements, more and more manufacturers are focusing on the evolution to DSCSA item-level traceability starting in 2023, with many processors making significant investments in serializing product lines and implementing serialized item traceability systems. Have you?
What is the Drug Supply Chain Security Act – DSCSA
In an effort to keep up to date a thorough understanding of this Act is important.
Quick definition: The Drug Supply Chain Security Act (DSCSA) regulation provides a national policy for combating counterfeiting, theft, and diversion in the U.S. pharmaceutical supply chain. Regulations providing for the tracing and verification of products and transactions from manufacturer to dispenser. – FDA for more detailed information.
“75% to 80% of the global drug supply will be covered under global track and trace regulations by 2018 [onward] — upward of 10’s of billions of units a year that companies across the industry need to manage.” – TraceLink
DSCSA History
2013 Drug Supply Chain Security Act (DSCSA) replaced a 50-state patchwork of pedigree requirements with one federal solution to trace prescription medications through the supply chain.
June 2014, FDA released draft guidance to help supply chain trading partners more readily identify, quarantine and investigate suspect and illegitimate products.
January 2015, manufacturers and distributors were required to adhere to enhanced product tracing requirements, with pharmaceutical dispensers following in July later that year.
Tracking item-level serialization starting in 2023 will be an important step that needs to be reviewed and planned for.
Product Serialization
Product serialization is the unique identification of products, which goes down to the level of individual items, rather than only at the batch level. Serialization pharma is the identification of individual packs of medications, that is, assigning them a globally unique two-dimensional code, and marking it on the packaging. – rfxcel
Summary
With the implementation of product serialization, a proper system for tracking and tracing products in the entire supply chain must be integrated. That kind of a comprehensive system will enable US wholesalers to verify the products, as well as exchange data with other wholesalers in the supply chain.
Obviously digitizing data would be a huge upgrade to any manufacturer’s ability to comply with these demanding serialization and most importantly traceability requirements. That’s what Coolearth does. To learn more about how Coolearth software can help with DSCSA compliance today and in the future click here.
Resources:
https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical
https://www.hda.org/issues/pharmaceutical-traceability
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