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Impending DSCSA Deadline Is Hot Topic At HDA DMC

The 2022 HDA Distribution Management Conference was the most well-attended HDA event in years. As the first in-person DMC since 2019, the conference drew in nearly 500 engaged attendees who were key stakeholders in the pharmaceutical supply chain. 

Impending Timeline

The DSCSA timeline and steps to be compliant were the premier topics at this year’s conference. With the FDA’s November 2023 deadline approaching, conference attendees heard from the FDA’s Connie Jung as well as representatives from HDA, GS1, AmerisourceBergen,  LSPediA, and more.   

Dr. Jung gave a virtual presentation that was similar to the one she gave during the FDA Public Meeting in November, 2021, outlining the steps of the DSCSA and the components of the final phase, which includes: 

  • Interoperable Exchange 
  • Interoperable Tracing 
  • Interoperable Verification 

Although most all of the attendees are, by now, familiar to what is specified in the final phase of the DSCSA, there is still some ambiguity as to how to reach a point of compliance to the law in order to avoid shipment delays. The November 2023 deadline is fast approaching. However, the journey to serialization, if not already in progress, must begin as soon as possible.  

One keynote speaker, Tim Urban, gave a pertinent speech during the conference, on procrastination and why people wait until the last minute to begin a project. Wholesale Distributors face the greatest pressure in getting their suppliers onboarded to EPCIS data transfer – a process that takes 4-8 weeks, or longer if a supplier does not have an existing ERP.  

The Big 3 distributors: Cardinal Health, AmerisourceBergen and McKesson, each have hundreds of suppliers to onboard. At this point only 10-15% of their suppliers are currently sending EPCIS data. Being that the Big 3 have set internal deadlines near the end of 2022 in order to have time to test and send EPCIS downstream to their dispenser customers, the potential for a logjam of onboarding suppliers in September and October appears likely if manufacturers don’t start immediately.  

LSPediA Leads the Way in Serialization Solutions 

LSPediA was a sponsor for all of the educational traceability tracks regarding the DSCSA regulatory requirement, industry implementation, and industry issues.  Many industry leaders stopped by LSPediA’s booth near the entrance of the DMC expo to discuss their serialization needs with our experts: Ilir Ivezaj, Ana Schleicher, Michael Ventura and Riya Cao.  

Attendees learned about LSPediA’s innovative exception management solution, Investigator for EPCIS as well as the new DSCSA Service Desk for manufacturers without IT personnel. LSPediA also gave away Shell gas cards and Yeti mugs during a raffle.  

Investigator is peerless in the industry. It automates the process of uncovering data errors, giving suppliers peace of mind that their shipments will arrive as scheduled.  

Speakers and Awards 

During the morning sessions, HDA presented the Industry Leadership Award for the years 2020, 2021 and 2022 to AmerisourceBergen President of Supply Chain Operations and Distribution Services Heather Zenk. She received the award for leading ABC’s vaccine distribution measures in the wake of the Covid-19 pandemic.  

HDA also invited numerous keynote speakers to present at the DMC. There was 20-year-old Ananya Chadha, a native of Madagascar who has worked with Elon Musk. As one of the Top-23 Women in Tech in Canada, Chadha gave an exciting presentation on the world of neurotechnology of which she is heavily involved. Closing out the conference was Deedre Daniel, the founder of the Interesting Conversations Company with a fun presentation of how to be more interesting than a cell phone. She shared her innovative board game and played portions of it with the crowd.  

The JW Marriott in Austin, TX hosted the four-day long event. The 2023 HDA Distribution Management Conference is scheduled to be held in Indianapolis, IN.  

Around the 2022 DMC

Top: LSPediA’s Michael Ventura and Riya Cao meet with Brad Pine of Smith Drug Company and Claudio Gallina of VAI.  

Middle: LSPediA friends and colleagues enjoy dinner together at Corner Restaurant during the 2022 HDA DMC

Middle: Ananya Chadha speaks during a morning session of the DMC 

Middle: Bill Carney of Genetco Inc. reacts after winning a Shell gas card from LSPediA 

Bottom: Heather Zenk of AmerisourceBergen accepts the HDA’s Industry Leadership Award