What DSCSA exceptions look like now, and how they'll change after November 27, 2023

March 3, 2023

It's a good idea to find out if your organization's supply chain processes have 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.

It's important to note how common such situations can be. While the focus of exceptions is often on getting the data right, sometimes the issue is with the product or the shipment; some standard shipping practices and eventualities can result in exceptions, keeping product from being received.

DSCSA exceptions: EPCIS data, no shipment

For example, it's common for trading partners who ship out pharmaceuticals to require multiple deliveries to fulfill a single purchase order. Even if everything is correctly documented in the EPCIS data -- the packages are serialized, have the correct product identifier, and are properly aggregated -- the shipments may not arrive at the same time. The receiving party already has the EPCIS file and knows to expect the rest of the purchase, but for that moment, they have an EPCIS order that technically doesn't match the product they have in hand.

This meets the description of an exception: a mismatch between the product as delivered and the EPCIS data for the order. The recipient can't proceed with the assumption that the rest will arrive; doing so defeats the purpose of DSCSA's requirements, as it would create a false tracking history that would only worsen the situation if, in fact, the missing delivery was lost or diverted. The product can't be received immediately, and yet, completion of the order may be imminent. It may arrive the following day; it may arrive after a week or more; it may not arrive.

Thinking outside the (labeled) box

In such a situation, the shipper may be able to find out more information or file a claim for missing goods. Under current circumstances, the receiver might request a credit for the missing products, and then issue a new PO for them. However, after DSCSA serialization, the recipient may need to decide whether to wait, to seek another EPCIS file, or to take some other course of action. The manufacturer would also need to be informed, such that any lost product can be flagged if it turns up elsewhere. All the while, the shipment is not received, and the dispenser cannot provide even the portion in hand to the patient.

Even trickier -- say a case arrives with a damaged label. Usually, the case can be discarded. and the items inside can be taken into inventory using the information on each individual package. But what if the package labels are damaged as well? They may even still have human-readable elements, but if the transaction data can't be recorded in EPCIS, then they can't be accepted. Recording them in an inventory system but not in EPCIS means there are competing records to sync down the line, which could be a problem if the status of the packages changes yet again.

The DSCSA Exceptions Pilot

There are answers to the above problems; certainly more than one apiece, in fact. LSPedia, joined by numerous partners, is gathering perspectives and walking through such situations in a practical way to see which options work smoothly, and which processes should be the standard between trading partners.

When November arrives, you'll want to know what to expect from your partners, just as you want to know what meets with the most success within your own organization. Strong, repeatable SOPs and communications, in addition to the right technology, can mean the difference between healthy supply chain operations and a costly quagmire.

Follow along with the Exceptions Pilot to find out more!