Wholesale distributors have the largest share of responsibility when it comes to being compliant with the FDA’s Drug Supply Chain Security Act (DSCSA). Not only are wholesalers required to verify incoming EPCIS data attached to every shipment, but they must also send that data to their downstream dispenser partners.
Recognizing the large part wholesalers play, VAI and LSPediA hosted an informative web event titled “2023 DSCSA Requirements: What You Must Do NOW to Prepare” on March 24.
High Stakes, High Risk
Everyone in the pharmaceutical industry is likely aware of the November 27, 2023 deadline for DSCSA compliance, but what was conveyed in the webinar was that the FDA’s deadline is a misnomer.
“The November 2023 date is what you’re shooting, for but it’s a much, more immediate urgency right now, especially from a risk perspective and mitigation perspective because a lot of things have to be in place and tested through. A lot comes into play,” said Michael Ventura, LSPediA Vice President, Solutions and Innovation.
When November 2023 arrives, pharmaceutical manufacturers and wholesalers will be unable to receive or ship product without an EPCIS data file attached to the product. If the EPCIS file is missing, incomplete, or contains errors, the shipment will be halted and placed in 3-day quarantine.
In that 3-day span, if the data is not corrected, the shipment will either be destroyed, returned or re-ordered, all at the supplier’s expense.
“Imagine entire shipments of product that do not have a good EPCIS file attached sitting on the receiving dock. For a wholesaler, that can be catastrophic,” said Ventura. “That’s a massive disruption in supply chain continuity. You’re not filling daily orders, and at the end of the day patients are not getting their products in a timely fashion.”
As VAI’s Claudio Gallina, VP Pharmaceutical Division noted, to avoid shipment pitfalls, first, you must be onboarded with EPCIS – a lengthy process that can take four months. If you don’t currently have an ERP, like VAI, that process can extend to 12 months.
“If you do the math on how many suppliers you have with each taking four months to onboard, it can be rather extensive,” said Ventura.
The Big 3 wholesalers have one eye on the present and one on the future. The timeline for them has a November 2022 deadline for their suppliers to be onboarded, so they will have a year to test downstream with dispensers.
Waiting until the last minute is a high-risk option however, as VAI sales manager Gina Perry noted.
“We are running out of time. Everyone thought the deadline was really far away when this act first came into place, and here we are approaching the culmination of it,” she said. “For me, the idea of onboarding thousands of providers and distributors all at the last-minute sounds like a really bad idea. I think we’re going to topple the network, and then it’s going to be a whole lot harder to fix. Load testing is a big deal from my perspective, and one of the things that scares me.”
LSPediA and VAI – A Winning Combination
VAIIntegrated LSPediA and VAI solutions will address the unique compliance needs of pharmaceutical wholesale distributors. LSPediA’s Investigator for EPCIS is the premier exception management solution. Your EPCIS files will always be scanned for errors with laser-focused accuracy, ensuring your shipments and accompanying EPCIS files are DSCSA compliant. The result is a worry-free workplace, enabling your business to focus on core objectives, knowing your shipments are secure.
With VAI and LSPediA your wholesale business will be a head above the rest, enabling you to go into 2023 with confidence.