At LSPedia, we're starting to see a troubling trend where pharmaceutical trading partners treat the November 27 enforcement deadline as the one they need to meet.
It's true that November 27 is the final enforcement deadline. But DSCSA is too complex to wait until the last minute, and there's too much at stake to rely on a situation where absolutely everything goes perfectly. How often do you take risks where success means meeting the literal status quo (though smart DSCSA implementation has many upsides and opportunities) and failure means you can lose your business?
These critical final months before enforcement conclude a decade-long transformation of the pharma supply chain. Once DSCSA serialization is in effect, every pharmaceutical product must be traceable at the individual package level, with EPCIS files logging every event since its creation, including transfers and aggregation into pallets and cases. Transactions will be handled entirely through electronic data exchanges, via interoperable connections between each pair of trading partners.
The pace of the change is accelerating. EPCIS file exchanges are rising drastically, and trading partners at all stages of their DSCSA journey are trying to gauge what to expect in terms of shipping and logistics this year. Crucially, some are setting their own deadlines for suppliers, with fines attached.
This just adds pressure and incentive to something any business needs when onboarding new technology and processes: time to try, fail, and learn.
it's inevitable that some businesses will delay until Fall 2023 or later, having underestimated the complexity of fully implementing DSCSA and making operational changes to their supply chain operations. Others will simply have failed to move forward with DSCSA at all, perhaps believing, wrongly, that business will more or less continue as usual. They may have the notion that the FDA would grant enforcement discretion, a case there's no evidence will happen.
But companies who aren't compliant are currently getting tough questions from trading partners who need their collaboration on interoperability, toward being able to continue business normally. (This is the principal element where fines might be involved, since not moving forward with these represents a potential business disruption.)
Exceptions are a major issue, and will only become more pronounced. A trading partner who isn't compliant with DSCSA will know something's wrong when their transactions fail, or take hours or days of exacting manual work to process. An exception occurs when data doesn't accompany the physical product, or if the data doesn't match the product as delivered. So, if a company cannot deliver or accept EPCIS files properly — or lacks the means to quickly process and correct them — their operations will become difficult, and doing business with them will also be difficult.
Businesses that don't take DSCSA compliance seriously are only going to hurt themselves. Even if there's nothing wrong with the product they're delivering or accepting, there will be no way for them to legitimately transfer or sell it if they can't properly account for it in their data. And, of course, after the deadline, they'll be at risk of regulatory penalties.
The final DSCSA deadline lands right after Thanksgiving. This is not, to put it lightly, a day, week, or even month (the arriving December) during which you'd want to deal with new shipping problems, as it follows a national holiday and Black Friday, and coincides with Cyber Monday. Besides, at that point, we're already into the Christmas business season, which brings any number of challenges.
So, the rapid coordination needed to introduce new systems at this point in the year may not be easily possible. Even if the key personnel within your business are available, those at your trading partners may not be. This, alongside any Q4 challenges a business may normally face in December, makes December a harsh timeframe for introducing any new systems, let alone ones that are essential to your ability to both legally and practically do business.
Long before then, of course, we'll have seen EPCIS rates reach much higher levels, and businesses — particularly hospitals and dispensers, which need to layer this change on top of a high-traffic, patient-facing environment — will have already faced greater pressure from partners to implement DSCSA if they haven't yet done so.
Realistically, then, businesses will face relationship-level and operational challenges long before they'll need to deal with penalties of non-compliance. This means that the deadline can't be dismissed as a single challenge, relegated to its business quarter; successful transactions and the efficient, unobstructed flow of product are going to grow as concerns throughout this year, starting now.
From that view, it's clear that the DSCSA deadline isn't the thing to worry about. Instead, focus on making the DSCSA decisions now to preserve your business relationships, improve your supply chain operations, optimize your budget, and manage your stress levels.
And if you don't have time this year at all? Contact Proactive Resource Group to fully outsource DSCSA!
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