As of today, there are just 100 days left before November 27, 2023, when the Drug Supply Chain Security Act goes into full enforcement. It's important to be realistic about what that figure means.
Though your mileage may vary (based on the type of trading partner you are, the size of your business, how many trading partners you have, how much progress you've made, etc), the broad implications are similar, and there's one overarching recommendation we can make:
One of the biggest mistakes any pharmaceutical trading partner can make this year is thinking that nothing will really change on November 27, as if a switch might quietly flip somewhere to get clean data flowing wherever it's needed. We've had to ground many companies in the reality that DSCSA isn't a centralized, automated system that kicks in behind the scenes, or a little extra paperwork, but a mandatory regulatory guideline that transforms how pharmaceutical supply chain operations do business, requiring active participation from every trading partner.
The first step, if you haven't made any progress yet, is simply to find out what's required. From there, you can evaluate the right solutions for your business. For a quick summary:
One way to take charge on DSCSA planning is to schedule expert training for your team. LSPedia's one- and two-day sessions provide hands-on experience and run through real-world scenarios, ensuring that attendees understand how DSCSA specifically applies to and can be addressed by their business.
Finally, take a realistic look at your team's capacity. If you're booked solid through the end of the year and don't have the bandwidth to give your DSCSA upgrade the attention it demands, you may want to consider outsourcing.
If you have a DSCSA solutions provider but their service hasn't actually materialized, even at this rater late date in 2023...it's safe to say that you don't actually have DSCSA solutions provider. Many trading partners tell us the same story: Their vendor offered a long list of features for a bargain price, yet once the contract was signed, wasted months saying each solution was "on the way" and that each technical issue "is getting fixed soon" if they responded at all.
When you hire a provider for something as essential as regulatory compliance — with your ability to do business at stake, no less — you should expect results. Demand evidence that they are processing EPCIS files; that they're fixing persistent technical issues; that they can help you legally transact data for every product exchange. Anyone who says otherwise is asking you to take an absolutely unreasonable risk, given what's at stake.
The very construction of DSCSA (across interoperable data exchange, serialization, and trading partner authorization) means that any uncertainty regarding your ability to do business also affects your partners. If you can't legally receive prescription drug products, other trading partners can't legally sell them to you. That's why some companies have set their own penalties for partners who aren't compliant already, recognizing that it's the responsibility of all pharmaceutical companies, from manufacturers to dispensers, to avoid supply chain disruptions. A pharma business tied to an underperforming DSCSA provider increasingly runs a reputational risk; don't let such providers take precedence over your trading partners.
Thus, DSCSA compliance providers carry a heavy responsibility, and must be able to guarantee and prove that the job will get done. That's how we've built LSPedia's reputation and the industry's best track record: giving our customers peace of mind. Our client-focused approach ensures that you stay on schedule, that the solutions fit your business, and that there's always support when you need it.
Trading partners of all sizes need to take exceptions seriously. The implementation of EPCIS across so many companies means the industry is dealing with more data, and more complex data, than ever before, and DSCSA imposes more stringent rules around such errors than ever before.
Under DSCSA, if transaction data is missing or doesn’t reflect the product as delivered, the receiving party must quarantine the product, and report and investigate the issue. At that point, movement stops, and the product can't be received or sold until the issue is cleared. The law states that each trading partner must have procedures in place to investigate suspect product, with a 72-hour window to resolve each instance.
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.
If a product isn't available as ordered, the next move may be to order a generic or find another brand, which can add great difficulty to filling a simple order (and potentially startle the patient, adding stress on the pharmacy end). And if you're losing inventory that you need, you might move on to conversations about increasing production to compensate. Further, pharmacies won't tolerate unusable product sitting while its status is sorted out. Space is limited and expensive.
Generally, the closer a medication is to reaching the patient, the more difficult and time-consuming an exception is to correct. Given the complexity of EPCIS files, the massive increase in their exchange, and the interoperable access and point-to-point collaboration required to trace problems, trading partners are going to want to ensure that any issues can be identified and resolved early and thoroughly.
Moreover, exceptions can be caused by alarmingly ordinary problems: split shipments arriving too far apart; labels being damaged or torn off boxes; simple data errors. By the end of 2023, they'll be a common part of life in the pharma supply chain, despite carrying potentially heavy consequences if they go unresolved.
A strong exceptions management solution can save you plenty of time, money, and stress. LSPedia's Investigator can ensure that most are caught before they can cause a problem, and that you and your trading partners are equipped to deal with them easily via automated alerts and a guided resolution process.
When it comes to implementing DSCSA data, at the risk of serious or even existential business impacts, 100 days isn't much time at all. Right now — mid-August 2023 — may not be your absolute last chance to get DSCSA done, but it's very likely your last chance to get it done in an organized fashion, at attractive prices, and without panicking.
Remember that you'll want to be compliant far before, not on, the deadline. DSCSA processes require adaptation time; it's entirely unrealistic to expect to flip a switch on November 27. Each connection can take weeks to months to establish, and will need testing before going live. Then, there are seasonal challenges: back-to-school, prep for fourth-quarter earnings, annual contract cycles.
And though it seems early to talk about the 2023 winter holidays, it's an unavoidable fact that the final DSCSA deadline lands right after Thanksgiving. This is not a day, week, or month when you want to deal with new shipping problems, as it follows a national holiday and a generally accepted shopping holiday (Black Friday), is itself another shopping holiday in its own right (the day now known as Cyber Monday), and marks the lead-in to the Christmas business season.
So, you simply can't count on the rapid coordination needed to introduce new systems at that point in the year. Even if the key personnel within your business are available, those at your trading partners may not be. It's a terrible timeframe to introduce new systems, let alone ones that are essential to your ability to legally, practically do business.
In short, starting now is your best bet. LSPedia has the pharmaceutical industry's best track record on DSCSA compliance; we can guarantee compliance after November 27 — and 99 stress-free days beforehand. Get in touch now.