We’ve been using our Blog for the last couple of years to remind you that the deadline for the Drug Supply Chain and Security Act (DSCSA) is fast approaching. The repetition of this message is warranted: every day that passes is another day closer to a deadline for which most of the industry may very well be unprepared.
There have been several deadlines on the way to the final one of November 27, 2023. But, while the pandemic has caused some of these deadlines to move back, there’ll likely be no such flexibility next year. This leaves every entity along the pharmaceutical supply chain just 21 months to finalize our industry requirements for compliance.
The Bottleneck of DSCSA Product Serialization Requirements
Extending traceability requirements past lot level to individual saleable units has made serialization a more formidable challenge. Consider that each unit’s Unique Product Identifier consists of four different bits of information:
- The product’s National Drug Code
- Serial number
- Lot number
- Lot expiration date
Together, the first two items on the list form a drug’s Serialized Numerical Identifier (SNI), which can be used for tracing purposes—but all four bits of information need to be transmitted for each transaction.
Having these standards spelled out is certainly helpful in getting the ball rolling for serialization. At this point, most drugs are packaged (or have been repackaged) with the SNI printed on each unit, an exception being those drugs which have expirations so far out in the future it doesn’t make sense to repackage them.
Creating this identification system was the easy part. The challenge has been in making sure all the information is transmitted for each transaction, which relies on both the seller and buyer using interoperable systems.
And this is where the bottleneck is happening.
Where Do You Go from Here?
With so many unknowns, it can be difficult for the smaller distributors and dispensers to settle on a plan. For those already using EDI for lot-level tracing, the move to EPCIS will be complex—complex enough that if you haven’t already started down the path to implementing it, you’ve already effectively missed the deadline. But that doesn’t mean you’re doomed. The best thing you can do right now is not to wait and see, but to be proactive. Ignore the unknowns, and focus on what we do know, and that is: everyone in pharma distribution will need to be electronically transmitting serialization data by November 27, 2023.
Reaching out to all your trading partners and finding out what they plan on doing is always a good start. You can’t judge the interoperability of any solution if you don’t know which external systems you’ll need to connect to. There isn’t some centralized infrastructure or network that’s handling all this communication, so for many it’ll be a matter of making sure your ERP platform can communicate with theirs—and that they both support these new traceability requirements.
At the very least, you need to make sure that, come November 27, 2023, you’re ready to conduct all the same business you do today, but within the bounds of the law. The only thing we can say for sure is that compliance won’t happen by waiting to see what everyone else does.