Applying GS1 Standards for the DSCSA

GS1US aims to help businesses and industries meet challenge through its GS1 Standards. As part of its educational thrust, the organization will host a one-day workshop for manufacturers, wholesale distributors and healthcare providers preparing for the requirements of DSCSA.

According the GS1 US, Phase 2 of DSCSA, by November 2017, will require pharmaceutical products to be marked with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format. The use of GS1 Identification Identifiers, Application Identifiers, and Data Carriers barcodes will be addressed in this workshop. In the GS1 System, the GS1 Global Trade Item Number® (GTIN®) is used to represent the NDC.

The organization says, "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. 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 2016 to 2023 time frame. We will review aspects of the Implementation Guideline, which provides the basics on how to identify and mark products, as well as how to share change-of-ownership information at the lot-level as well as the serialized item-level."

Further information is available.