A lot of us in the pharmaceutical industry come to conferences and seminars with low expectations: No news is good news, is what we seem to be thinking. But, boy, last week’s HDA event proved us wrong.
DSCSA deadlines are inching closer for manufacturers, repackagers, wholesale distributors, and dispensers. In sight right now are the 2017 serialization and 2019 saleable returns target dates. But, for many, more worrisome than the deadlines are the unanswered questions, lack of guidance, open issues, and unclear expectations. Last week, a record number of pharmaceutical supply chain professionals flocked to the HDA Traceability Seminar in DC, making the event the largest ever with 450 attendees. Most were there in search of answers, direction, solutions, and regulatory guidance.
The conference started in a familiar way. The agenda covered topics similar to the HDA’s March DMC conference in San Antonio, Texas, last March – an FDA update followed by a discussion of 2019 saleable returns requirements. Not surprisingly, the FDA still couldn’t answer specific questions about anything that isn’t already spelled out in the law: Grandfathering Guidance hasn’t been finalized, and no, there won’t be an FDA DSCSA pilot due to lack of funding.
Ho hum. But, no – because after the FDA session, that’s when things got interesting. The seminar suddenly bloomed into a vivid discussion of new experiences, fresh information, and bold thinking, all of it leading to a new horizon – 2023.
Many Players, One Goal
My view is that the implementation of the DSCSA has and will continue to transform the pharmaceutical supply chain. Thanks to unprecedented collaboration and teamwork across the industry, especially among supply chain partners, a lot has been accomplished since the enactment of DSCSA in 2013, with businesses reaching out to suppliers, customers, and even competitors. “We are in this together,” said John Quentin Dittman of Cardinal Health, sharing DSCSA implementation lessons learned during Friday’s Industry Panel Session. Those on the stage with him perfectly represented that industry collaboration: Gaurav Banerjee from Sharp Packaging, Mark Gutmann from Mylan, Lloyd Mager from Abbvie, Andrew Meryer from Mutual Wholesale Drug Company, and Scott Mooney from McKesson.
And that was just one example. On Thursday, the HDA presented the outcome of the collaborative work done by supply chain partners. They covered a lot of ground, and spoke about a number of topics, including:
- Meeting DSCSA 2019 Saleable Returns Requirements – HDA Pilots Discussion
- International Perspective: Meeting Requirements Around the Globe
- An Overview of HDA White Paper and Desktop Pilots
- Global Perspective: APEC Business Advisory Council (ABAC) Serialization Pilots
- Retail/pharmacy community perspectives and expectations
- 3PL perspectives of data exchange and ownership.
- EPCIS 1.2 release and blockchain
On Friday, the meeting continued with powerful industry knowledge sharing, including an industry panel discussion about important considerations as we approach 2023, and HDA views on 2023 implementation requirements.
All Eyes on the Future
Up till this seminar, most companies were focused on the 2017 and 2019 requirements. As those implementations move toward completion, everyone’s focus is shifting to 2023. That requirement, interoperable product tracing, is in many ways the most complex challenge of it all. The DSCSA calls it the “Enhanced Drug Distribution Security,” and starting in 2023, all partners in the supply chain will have to follow the rules laid out in the legislation:
- Trading partners shall exchange secure, interoperable, electronic transaction information (TI) and transaction statements (TS) when there is a trade, defined by change of ownership
- TI shall include the product identifier
- Only accept the returned products when there is matching TI and TS
- Verify TI and TS; also respond to request with TI and TS
- Provide TI for each transaction going back to the manufacturer if requested by FDA or trading partners
The law is the law, and it will not wait for you to catch up. The industry has seven years to figure this puzzle out. Implementing the 2015 and 2017 requirements taught us a lot of about deploying new processes and new systems. We learned that the work is rarely done as fast, cheap, and easy as you believe starting out. More often it’s the opposite.
Laying the Groundwork for Smoother Compliance
The HDA Seminar made one thing clear: The 2023 mandate is going to be a complicated undertaking for most organizations. It will require more computing power, increased collaboration, and roll-up-your-sleeves commitment from all partners in order to make it work. The good news is that there are new solutions available right now to help you meet the 2017, 2019, and 2023 requirements. LSPediA is proud to contribute one of those solutions to the industry, our very own RxChain.
RxChain is an interoperable Track-n-Trace supply chain solution that is fully compliant with DSCSA 2017, 2019, and 2023 requirements for serialization and interoperable data exchange. And it offers unique capabilities not found elsewhere. Most solutions stop after the trade (change of ownership), and they lose all movements of serialized product within the four walls, including receiving, reconciliation, inventory changes, and shipping. RxChain is the first and only solution that traces serialized trade data and serialized inventory movement data within the four walls. It enables the following capabilities:
- EPCIS data exchange
- Serialized data collection for inventory movement and exceptions
- Product verification for receiving, returns, and responding to request
- Scan and track serial numbers on the outbound shipping
Get Started on 2023 Today – with LSPediA
To get your business on the road to DSCSA compliance, contact LSPediA. We can ensure you understand and successfully implement a DSCSA strategy using our industry-tested serialization toolkits and our new, innovative traceability solution, Rx Chain.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.
For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com.
For additional information, contact: Julianne Jahn [email protected]