Yes, there are 200 days left before November 27, 2023, the FDA's final enforcement deadline for the Drug Supply Chain Security Act.
Is that a lot of time? Yes — if you use it well. The answer depends on how prepared you are already, and what you're going to do in the remaining few months.
And note that that time isn't just yours, as onboarding DSCSA requires cooperation internally and externally. Think about timing windows: people tend to go on vacation over the summer, and in the weeks before November, ramp up critical quarterly and end-of-year efforts. Planning for DSCSA doesn't occur in a vacuum, but relies on careful coordination within your company and among your partners.
Here are a few ways to make sure you're getting the most out of that time — and not letting any of it go to waste.
Before you can make any moves toward DSCSA compliance, you need to get a full view of what's expected of your organization.
Though the same essential concepts affect all pharmaceutical trading partners — interoperability, serialization, EPCIS, exchanging data before or during a physical transaction, reporting illegitimate products to the FDA — there are factors that are unique to each trading partner type, as defined in the FDA's July 2022 guidance.
Get a quick look at these from our trading partner pages:
However, you can take your prep even further by attending our expert-led training programs, like our free monthly webinar for dispensers starting May 18, or our complete DSCSA 101/201 and 301/401 training track, next occurring June 7-8. Check our Events page for more!
It might be tempting to believe that not much will change on November 27, but that just isn't true. DSCSA serialization is transformational, and its measures are in place to ensure that suspect, illegitimate, diverted, or recalled medications don't make their way through the supply chain to patients. As such, industry cooperation is essential and will be enforced, both by regulators and by your trading partners.
As an expert from law firm Arnold & Porter told Regulatory Focus, you can expect FDA inspections to cover DSCSA compliance, including trading with Authorized Trading Partners, having interoperable data connections, exchanging data ahead of transactions, and using product identifiers.
Your trading partners will expect you to comply with DSCSA, and some take the deadline so seriously that they're enforcing their own penalties for not meeting onboarding deadlines far in advance of November. This is because failing to comply will seriously disrupt business, and compliance is a team effort.
Any product that arrives without EPCIS data must go into quarantine, and if you can't send or receive the data, you can't send or receive any product. So, it's understandable that some trading partners take such measures to protect their business — they need to know who's going to be ready and who's going to be a problem.
Since onboarding can take weeks or months for each connection, start now if you haven't made progress yet!
If your provider told you they can't establish EPCIS onboarding with certain trading partners, they're wasting time. First, your provider's limitations should not affect who you do business with. Second, that's not how interoperability works.
All serialization and traceability solutions must be interoperable. There won't be a separate system for continuing outside DSCSA data. Interoperability is a must, and EPCIS onboarding must be done for every company with whom you exchange goods.
These connections enable the traceability and supply chain visibility that the law was written to create. So, a DSCSA provider who won't work with one or more of your current trading partners is not solving your problems, but creating many more. Address this now rather than letting it put your efforts behind schedule.
You'll need a playbook for DSCSA exceptions, the discrepancies between product and order data. These might seem like everyday annoyances at present, but after November 2023, they can stop product movement, a factor that can incur new business costs and require large amounts of time and labor to fix.
Under DSCSA, missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be cleared. This means that a showstopping exception can force tough choices on how to deal with product, including whether it ought to be quarantined temporarily, returned to the sender, or even destroyed. And each of those scenarios causes additional problems, since none of them result in the medication reaching the patient in a timely fashion.
The rate of exceptions will only escalate this year as we approach the deadline, and more trading partners begin exchanging and processing serialized data. So, the only way to minimize supply chain disruptions is to to put in place strong resolution, collaboration, and prevention processes.
Preparing an exceptions management solution now will save you massive amounts of time and frustration later on.
Yes, we're talking about LSPedia here — and with good reason. Our technology is cloud-based and system-agnostic, meaning that there won't be any limitations around your ERP system or any other existing tools.
We'll form interoperable connections with any of your trading partners, and will ensure that you're not only fully compliant, but have the resources to lead the process with your partners who aren't up to speed. In addition to establishing these connections conveniently, we also work with SAP to offer pre-tested, qualified connections that can make the process a snap.
Further, our Investigator technology is the industry's leading solution for exceptions management, ensuring that you're automatically notified of any transaction problems and fully equipped with solutions, including a guided resolution process.
Make these 200 days count — reach out to the LSPedia team today to get started.