LSPediA Customer Advisory Board: Compliance Guarantee, EPCIS Deadlines, and FDA Draft Guidance

September 20, 2022

At its latest Customer Advisory Board webinar, LSPediA presented new developments in its ability to guide its clients through DSCSA implementation and beyond. As well, the event featured special presentations on EPCIS exceptions and the FDA’s new proposed rules, by experts from AmerisourceBergen and GS1. 

Compliance Guarantee: Peace of Mind for DSCSA 

Trading partners are facing a complex challenge with DSCSA compliance ahead of the fast-approaching November 2023 deadline, and they may lack the quality infrastructure and expertise they need to fully prepare their operations or even understand how much they have left to do. 

To help them adapt quickly, LSPediA’s Compliance Guarantee offers a customized plan to resolve an organization’s compliance gaps, supported by Service Desk expert advice in the critical areas of quality, DSCSA transactions, and exceptions management. The program can also bolster these efforts with access to classes and a designated Compliance Officer, to stay on top of enforcing DSCSA requirements into the future. Find out more about how to get your organization started with the Compliance Guarantee. 

Progress on EPCIS 

Ameer Ali, Senior Director of Manufacturing Operations at AmerisourceBergen, took attendees through the critical 2023 timeline for implementing EPCIS, and outlined what progress the industry has made so far.  

AmerisourceBergen’s suppliers will be tested and onboarded for using DSCSA-compliant EPCIS 1.2 data by the start of 2023, and it has set a deadline of August 1 to have 100% EPCIS data from suppliers with DSCSA shipments. And by the critical deadline of November 27, the company will see complete implementation of serialization systems, and will have no product movement in the supply chain without serialized transaction information (TI) data.  

AmerisourceBergen has onboarded about 30% of the nearly 500 manufacturers who are in scope of DSCSA, while 43% are either in progress or have provided readiness dates by Q1 2023. Ali said he is “very concerned” about the 27% who have not given a readiness date, as getting started too late means rushing to meet multiple complex deadlines and putting shipments at risk. 

Ali emphasized the importance of having an exceptions handling strategy, recommending early testing and onboarding, conducting pilots, and holding continuous monitoring and communication in the production environment. To maximize efficiency, AmerisourceBergen uses LSPediA Investigator for EPCIS, which offers immediate error notifications, customized messages based on error types, accurate info on exceptions, and automation to reduce staffing impact. 

FDA Proposes 12-digit NDC 

Tracy Nasarenko, Senior Director of Community Engagement at GS1, detailed recent draft guidance from the FDA, published July 25, with a comment period through November 22. The agency proposed the adoption of a 12-digit National Drug Code format, broken into six, four, and two-digit segments. The change would streamline out the additional complexity of converting NDCs, and avert the depletion of 5-digit labeler codes (anticipated in the next 10-15 years). 

Nasarenko added that the FDA proposed to delay the effective date for five years, to give trading partners time to transition over. Afterward, existing 10-digit NDCs would be required to convert over the next three years.

What’s next?

Don’t miss our next Customer Advisory Board meeting on October 25! Guest speaker Eric Marshall, Principal for the D.C. Office of Leavitt Partners and Executive Director of the Partnership for DSCSA Governance (PDG), will discuss the how the organization supports DSCSA interoperability, why governance is important to interoperability, and how you can get involved. Register here.

Also, stop by our YouTube channel to see an LSPediA Customer Care meeting featuring CEO Riya Cao and Genetco VP of Operations Bill Carney.