Happy Independence Day!

After many years of uncertainty, FDA has (finally!) recommended that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements.

Prior regulations and guidance were less specific; only mandating that standards of interoperable exchange “shall comply with a form and format developed by a widely recognized international standards development organization.”

With this guidance, FDA is more specific:

1. Solution providers possess processes and capabilities that enable the exchange product tracing information
2. Electronic approaches have evolved and become more affordable and accessible to a wider range of trading partners
3.  FDA is specifically interpreting the enhanced drug distribution security interoperability requirements to encompass the ability to securely exchange, capture, and maintain electronic transaction information and transaction statements accurately, efficiently, and consistently among trading partners

Furthermore, FDA recommends that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. FDA cites the following reasons for this decision:

1. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain.
2. EPCIS can support and enable electronic and interoperable interfaces used by trading partners to ensure compliance with DSCSA
3. EPCIS is compatible with a range of different technological approaches.
4. Industry stakeholders have championed EPCIS as a suitable standard to adopt for the enhanced drug distribution security requirements.

To achieve compliance with enhanced drug distribution security interoperability requirements trading partners should make a collaborative effort to follow accepted, industry application standards such as GS1 EPCIS.

Gateway Checker, as a certified GS1 Conformance Testing Service is a leading provider of tools, techniques and technologies that verifies and validates EPCIS content, schema, and structure.

Gateway can quickly and effectively assess DSCSA conformance and traceability readiness.

Contact us for a Readiness Assessment.

Download the Guidance: DSCSA Standards for Interoperable Exchange

EPCIS (Electronic Product Code Information Services) is a standard developed by GS1. For more information see https://www.gs1.org/standards/epcis

Thanks!