What are DSCSA exceptions, and how do you deal with them?

November 16, 2023

What are DSCSA exceptions?

In just under two weeks, every trading partner in the pharmaceutical industry is expected to have DSCSA-compliant systems in place. After November 27, 2023, they'll spend the next year testing and stabilizing them with their partners; slowing down or stopping progress on DSCSA brings the risk of audits and penalties, according to statements by the FDA.

With this timetable in mind, it's essential to plan for exceptions, the data errors that occur when the product as delivered doesn't match the transaction data that must accompany it. In any scenario, the receiver must investigate that transaction with the shipper and resolve the matter (often with re-submission of a clean file) before the product can be taken into inventory.

When an exception occurs, it doesn't necessarily mean a product is illegitimate or harmful, or even missing; it just means something unexpected happened, and that something doesn't match up. But before we can go into that, it's important to have the basics on EPCIS files.

What are EPCIS files?

Electronic Product Code Information Services, or EPCIS, is a standard developed by the organization GS1 to capture and share events in an item's history, and make them readable in a common, interoperable way. This provides visibility into a product from its creation to final end-user sale, helping trading partners share exact information between organizations, supporting accurate track-and-trace operations.

For pharmaceutical products, EPCIS records:

  • Item identification: A unique identifier assigned to each product unit (serial number, GTIN, EPC)
  • Event data: Information about the transaction, movement, or status of the product, such as transaction history, transaction information, and transaction statement. (Note: Transaction History is being phased out with the final serialization deadline of November 27, 2023.)
  • Location and time data: Information about the location of the product, such as facility, warehouse, or retail, and when it was received, shipped, or transferred between sites.
  • Business data: Information about the transaction associated with the product, including the parties involved, quantity of product, and terms of the transaction.
  • Aggregation: Details on how the product has been aggregated to a case or pallet.

EPCIS files, while perfect for the task of providing an item's complete history, are quite complex, designed to be read electronically (ideally with purpose-built software). This contributes to the rising rate of exceptions: more and more companies are using a more complex standard, and the introduction of item-level traceability vastly increases the sheer number of them exchanged.

Put another way, there are more errors to catch, more ways to catch errors, and more room for unexpected issues to occur.

How do exceptions happen?

Under DSCSA, missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be received into inventory. So, an exception that lacks an immediate fix can force the receiving company to make tough choices on how to deal with the product they've received, including whether it ought to be returned to the sender or even destroyed. And each of those scenarios causes additional cascading problems, since none of them result in the medication reaching inventory (or the patient) in a timely fashion.

Let's take a somewhat common example: If a split shipment arrives across two different days, it will not match the EPCIS data, thus causing an exception. For another, if a label is damaged, the receiver won't be able to be certain it matches the data they have. In yet another case, the EPCIS data might not have arrived by the time the product has.

Product movement must stop if the exception cannot be resolved. Further, under DSCSA's Enhanced Security provisions, exceptions must be resolved within 72 hours. Is that a lot of time? At present, no; it's still shockingly common for difficult exceptions to take days or weeks, meaning that sometimes they're "resolved" by the receiver simply canceling the transaction and re-ordering, which is a major drain on time and cost. However, with a robust exceptions management solution like LSPedia's OneScan Investigator, resolution times can be negligible, thanks to automated error detection and guided resolution.

Why Do I Need An Exceptions Management Solution?

The increased functionality of EPCIS contributes to its complexity; trying to process a file "by hand" (that is, reading it without specialized software) essentially means attempting to read dozens or hundreds of pages of lines of code. It's a time-consuming and frustrating endeavor at best; this is one reason it's so important to have a DSCSA solution in place to handle them for you.

Without a robust system to manage EPCIS exceptions, any daily receiving effort could require additional hours or even days to resolve, rather than minutes. That's an expensive slowdown, and a headache for both the receiver and the shipper. Quarantine storage also requires valuable space, particularly for product that legally cannot be sold or moved through the supply chain (outside of a return) while its status is in question.

Generally, the further along a medication is in the supply chain —  from manufacturer to distributor to dispenser to patient — the harder and more time-consuming an exception is to correct, as more inquiries will be required to understand the problem. 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.

LSPedia and its partners held the 2023 Exceptions Pilot to make sure there are resources, procedures, and standards that can help companies across the pharma supply chain handle new exceptions as they emerge. There's now a framework for what to expect, but the industry's transition to serialized data means a hundredfold increase in data exchanges. Inevitably, this will bring more errors, and many complex new situations for trading partners to work through together under pressure.

How Do I Get Started With DSCSA Exceptions Management?

LSPedia's Investigator, a module of its OneScan Suite, can cut the resolution time for an exception from days to minutes by automatically alerting users to EPCIS errors and guiding them through the resolution process, enabling them to locate a problem before it can stop business. Its notifications send live hyperlinks that allow the point of contact to quickly view the issue and apply necessary fixes.

Further, outsourcing to Proactive Resource Group can move the exceptions management function offsite entirely.

Contact us today to learn how to secure your business with industry-leading exceptions management.