As 2024 continues, the November 27 DSCSA serialization deadline looms large over the entire pharmaceutical supply chain. If panic hasn’t already set in for authorized trading partners (ATPs) — such as manufacturers, distributors, repackagers and dispensers, among others — whose systems are not yet compliant with the law, it probably will soon. Unfortunately, with panic comes short-term decisions that become costly in the long run.
Of course, these portents of doom and gloom were common around this same time last year. But while the Food and Drug Administration (FDA) chose to give all ATPs some additional time to prepare with its “stabilization period,” that period ends this November. Whether the FDA will provide more time for ATPs to get up to date or simply begin enforcing the law is anyone’s guess.
That leaves ATPs with three options:
1. Do nothing and hope the FDA provides more runway
This approach requires minimal upfront costs in terms of investment, but high costs in terms of negative business impact should this strategy fail; and anyway, ATPs would only delay necessary costs — the chickens must come home to roost eventually.
For example, imagine you are upstream the supply chain. Somewhere down the line, some partner or regulator is going to require the GS1 Electronic Product Code Information Services ("EPCIS”) file. If you can’t provide the data, you are not only non-compliant yourself; you are making your customers non-compliant as well. The result could be your customers leave you for a supplier that is compliant, and this could have a domino effect on your business. As an intermediary, it will be much harder to hide from DSCSA serialization, unless your customers decide to be non-compliant as well.
2. Implement a "Band-Aid" solution
Alternatively, you could create a repository alongside manual inventory reconciliation and do dual entry for every single shipment that comes into your facility. This may work for a little while; but the bottlenecks would become too much to bear, increasing warehousing and distribution costs and delaying shipments. At that point, you would be forced to revert to using only the repository and reconcile the inventory later — a "later" that may never come because you’re just too busy.
Eventually, your repository data likely would not match your inventory data; your pharmaceutical inventory may even end up being sold on the street.
3. Establish Built-in DSCSA Serialization Compliance
Tecsys' Elite™ WMS for healthcare distribution is the only warehouse management system that locally maintains full inference data on SGTIN-96 (”SGTIN") and SCC and fully embeds DSCSA regulations within each individual warehouse transaction. This offers real-time reconciliation of inbound and outbound inventory in tandem with the EPCIS repository.
That means no dual entry and no manual reconciliation are required at receiving, picking and shipping. It allows for a completely seamless DSCSA-serialization compliance process in your warehouse so you can focus on what’s truly important: optimizing your operations, delighting your customers and growing your business.
There is no way of knowing what the immediate future holds when it comes to DSCSA serialization, but we do know what is required in the long-term: full compliance in the warehouse. Now is the time to invest in that future so you can sleep easy once we reach the true deadline.
Why compliance matters now
There’s no question that compliance with the law is going to put additional strain on your business. Depending on where you are situated in the pharmaceutical supply chain, the technological burden may be heavier for some ATPs than others. The question is whether you want to feel the strain before the deadline, or after it. Regardless of what business you’re in — whether at the beginning, middle or end of the pharmaceutical supply chain — the stakes are just as high, and the impact on patient safety is real. Investing in compliance now not only shields your business from potential penalties but also strengthens your position in a competitive market that values trust and reliability.