The pharma industry’s been waiting for this for some time. Back in February, I blogged about McKesson’s (MCK) letter laying out its four serialization requirements for suppliers and manufacturers. To me, the most interesting one was their expectation that “Serialized DSCSA information will be exchanged by industry trading partners using the GS1 EPCIS format for transactions when sending data.” The exact date that MCK “expects serialized DSCSA information” wasn’t specified, which went on to create a fair amount of confusion in the industry.
The simple fact is that it takes significant capital and resource investment for a company to acquire the ability to provide serialized DSCSA information to a wholesaler. And without a clear timeframe, such an investment decision can turn into a catch-22: Invest now, and your technology purchases could sit idle for some time; invest later, you may miss the deadline and put your business at risk.
Since then, the industry has been on the lookout for guidance. Specifically, companies wanted to hear from Cardinal and AmerisourceBergen (ABC) about how their requirements will mimic or differ from MCK’s. Without that information, it was difficult to move forward. Then last week, that guidance finally arrived – from both companies.
Let’s first look at Cardinal’s letter. In next week’s blog we’ll cover ABC.
Cardinal’s Serialization Requirements – Much Needed Clarity
Cardinal sent two communications in April. The first addresses Cardinal 3PL clients that contract Cardinal as their third-party logistics (3PL) provider. The second addresses manufacturers that ship products to Cardinal Health, the wholesale distributor. Since the second letter is more complex, let’s unpack them in reverse order. Here are Cardinal’s specifications for manufacturers shipping to Cardinal Health:
- DSCSA Requirements: Manufacturers need to meet the 2017 serialization deadline (2018 for re-packagers) and wholesale distributors must meet the 2019 deadline for verification of re-saleable products.
- Serialized Data Exchange: “The timing… is pending the outcome of the HDMA 2019 Saleable Returns Verification pilots.” Translation: Cardinal may require serialized data exchange as early as January 2019.
- Aggregation: “Cardinal Health expects that manufacturers will aggregate individual units to the case level.”
- Product Identifiers: Cardinal Health expects manufacturers to use GS1 standards and also align to HDMA guidelines.
- Master Data: Cardinal Health asks manufacturers to use GTINs and GLNs in GS1 standard.
- Trading Partner Technical Guide and Pilot Activities: Cardinal Health published a 10-page document detailing the requirements for barcodes, master data, and EPCIS serialized data exchange.
There’s a lot of detail here to help guide decisions. For one, while the MCK letter didn’t lay out a timeline for the serialized data exchange, the Cardinal letter does: January 2019 or later. And, in the Cardinal Technical Guide, the company offers a clear path for companies interested in engaging in the pilot and/or test activities for serialized data exchange.
The guide also points out an important Cardinal decision, which states, “Cardinal Health will not incorporate automated SGTIN validation as part of our Receiving process at this time…. What this means for piloting purposes is that our EPCIS system will be decoupled from our production receiving processes, and we will conduct pilots using our EPCIS repository in a manual and highly controlled fashion, providing feedback on labeling, aggregation quality and DSCSA content (if applicable) for each Manufacturer who participates.” In other words, don’t stress about the data attached to your shipment during the pilot phase: Cardinal will receive your shipment even if it arrives with less than perfect serialization information.
Overall, the Cardinal 3PL communication focuses on Cardinal’s commitment to receive serialized data in order to support its clients. It also comes with a technical guide, but specific to 3PL clients. The letter indicates that Cardinal 3PL will start testing “serialized data exchange” as early as June 2016 and offer “Data/Reporting Service for those clients seeking a solution for data retention and verification requirements” in September 2016.
3PL is a critical part of DSCSA compliance for pharma companies. With this communication, Cardinal truly established itself as a trusted partner and an industry leader. In an era of changes and uncertainties, that’s good business.
Simplify Serialization with LSPediA
With guidelines in place and requirements on the table, the time to start serialization is now. The LSPediA Serialization Toolkit is helping companies like yours implement all aspects of DSCSA compliance – including serialization, aggregation, and other regulatory and operational needs.
To find out how 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.