The implementation of the DSCSA will take companies from tracing products at the lot level to product serialization, and then item-level traceability. The first phase, beginning January 1, 2015 and ending December 2022, requires that supply chain participants share chain-of-ownership data. The second phase, beginning in November 2017, requires that pharmaceutical products be marked with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date in both machine-readable and human-readable format.
The third phase of DSCSA, meanwhile, requires that trading partners share chain-of-ownership data to allow for serialized item traceability back to the product origin.
This latest guideline serves an implementation guide to help companies understand how to apply the standards to their own business processes to support DSCSA lot-level management and item-level traceability.
This current version of the guideline also provides the basics on how to identify and mark products, and how to share change-of-ownership information at the lot-level as well as the serialized item-level. “Future versions of this guideline will provide information on how to manage in a mixed environment, and provide specific guidance on exception processing and additional forward and reverse logistics events,” GS1 says.
EPCIS
As the healthcare industry prepares for a decade of change, theindustry “has rallied around the use of Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability,” GS1 says, noting that EPCIS enables supply chain partners to capture data on supply chain events and to share that information with their trading partners “securely and in near real-time.”
The new guideline includes a new means by which companies can share lot-level management data for DSCSA lot-level requirements, including transaction information, transaction history and transaction statement. The original guideline was developed around California serialization requirements, but the latest version will help companies align with the DSCSA requirements for item-level traceability.
The guideline also identifies the GS1 standards used and provides details about how they can be applied toward product serialization, lot-level management, and item-level traceability. It includes all of the EPCIS Business Step and Product Disposition combinations used for each supply chain event.
In order to remain current, the guideline will be updated as necessary to reflect feedback from industry pilots, architecture work being conducted by GS1, and other industry efforts.
Expectations
“Although the DSCSA law specifies 2023 as the year when serialized item traceability is required, many trading partners have already made significant investments in serializing product lines and implementing serialized item traceability systems,” GS1 says. “And as more and more trading partners start to transition from lot-level management to serialized item traceability, it is reasonable to expect that the U.S. pharmaceutical industry will experience a mixed environment of lot-based and serialized item information throughout the 2015 – 2023 timeframe.”