Every company that needs to meet compliance requirements benefits from economies of scale: If you can duplicate your efforts across locations, you save a lot of time and money. But if you have to create new processes for every market, all of the specialization – or localization – is going to cost you, in time, money, and effort.
Global Serialization: The World Is Not Flat
I wrote about this problem and how it’s impacting the worldwide pharmaceutical industry in two previous blogs (E.U. Serialization and U.S Serialization: Four Differences and One Big Similarity and The “Good News, Bad News” Predicament of Global Serialization). In those posts I looked at the challenges of trying to implement global serialization without global harmonization around standards. Lacking a consensus, it’s impossible for a manufacturer to scale their serialization solution. In other words, when every country has its own set of requirements, every serialization solution needs to be fine-tuned to those nuances. Without duplication and scaling, it’s much harder to earn a profit, and it opens the door to errors and slowdowns.
U.S. Serialization: Much Better, but not Perfect
With DSCSA deadlines approaching, domestic serialization coordination efforts have been a big topic lately. (See Are Wholesale Distributors Ready to “Harmonize” their DSCSA Serialization Requirements?.) Manufacturers are wondering if they’ll be forced to develop unique processes in order to meet different wholesale distributor requirements, or if they’ll be able to develop once and scale out.
First, a bit of history: After decades of mergers and acquisitions, the industry is polarized: At one end sits the big three – McKesson, Cardinal Health, and AmerisourceBergen – who make up 80-90% of total sales for many manufacturers. At the other end are hundreds of smaller wholesale distributors picking up the remainder of the business. So, when we talk about whether wholesale distributors will harmonize their standards, we’re really talking about the big three.
In the last few weeks, I did a detailed analysis of serialization requirements as they were communicated by the big three:
- McKesson: Wholesale Distributors Deliver Clarity Around Serialization and Aggregation Requirements
- Cardinal: Cardinal and AmerisourceBergen Issue Serialization Requirements
- AmerisourceBergen: Cardinal and AmerisourceBergen Issue Serialization Requirements – Part 2
Serialization and the Big Three
Now let’s compare them side by side. First, some good news for manufacturers – the similarities:
- Lot-level data exchange: All three ask manufacturers to keep sending their lot-level DSCSA information via ASN.
- Product serialization: All three require manufacturers to serialize units and cases.
- Product identifier: All three are aligned to GS1 standards.
- Serialized labels: All three request that manufacturers serialize prescription drug products before November 2017, following GS1 standards.
- Aggregation: “Cardinal Health expects that manufacturers will aggregate individual units to the case level,” while McKesson and AmerisourceBergen expect all levels of aggregation.
- Serialized data exchange: McKesson said yes to serialized data exchange, with no specific start date; AmerisourceBergen sets the timeframe at early 2018, and Cardinal Health at early 2019.
In summary, the big three have a lot in common with regard to serialization requirements and timelines, and much of that agreement can be traced back to the DSCSA – especially numbers 1 to 4, lot-level data exchange, product serialization, product identifier, and serialized labels.
Some Important Differences
Things get a little trickier with numbers 5 and 6, aggregation and serialized data exchange. Although both are mandated by the DSCSA, they have effective dates of 2023. The big three are pulling those deadlines forward – but for a good reason.
While the law doesn’t require aggregation and serialized data exchange until 2023, it requires partners in the drug supply chain to verify returned resalable products by 2019. The catch is that without aggregation and serialized data from the manufacturers, verifying returned resalable products will be a logistical nightmare. Lacking those processes, a wholesale distributor would literally need to open all the returned cases and call manufacturers to authenticate each serial number. Impossible.
This issue impacts all the partners in the pharmaceutical supply chain. . Manufacturers are especially divided. Many made the decision not to aggregate years ago, based on the DSCSA 2023 deadline. And reversing course now would be a financial disaster, and nearly impossible to achieve anyway given the time crunch.
Meet DSCSA Compliance and Serialization Requirements with LSPediA
Despite well-laid plans in the industry and the comprehensive nature of the DSCSA, complexity is popping up in unexpected places. Serialization implementation requires an organization-wide strategy and careful navigation – one small oversight at any point can end up costing you significant time and money. A trusted partner – to act as advisor and implementation project manager – can make all the difference. And LSPediA is the partner of choice for a growing number of pharmaceutical companies.
The time to begin serialization is now. Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact us today.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.