Those of us with years of experience know how one serialization project quickly turns into many serialization projects. We also know how each of those pieces deeply impacts different parts of the business—operations, supply chain, IT, and quality. Plus, executing complex projects like serialization in a compressed timeframe is stressful and overwhelming—one wrong turn can have a snowball effect, causing even bigger problems down the road.
To help you avoid mistakes and take the right steps at the right time, we’re publishing a multi-part blog on DSCSA dos and don’ts. No matter where you are in the process, these handy to-do lists will help you plan for DSCSA success, get ahead of common roadblocks, and stay on track to meet every deadline.
10 To-Dos for Everyone Working toward DSCSA Compliance
- Know the regulations: This includes knowing mandatory DSCSA rules, but also being familiar with the many guidance documents published by FDA in the last three years. Pay attention to what you are required to do, as well as what you are exempted from—it’s important to know your responsibilities, but also what you’re not responsible for.
Also remember that there’s a lot of noise in the marketplace. Just because someone said something, that doesn’t make it true. I highly recommend you digest the DSCSA and the guidance documents so you stay centered in your decision-making process. (And if it sounds like too much work, help is available. Go to the end of this blog and click “contact us.”)
- Know the customer (wholesale distributor) requirements: Manufacturers who do business with the big three (McKesson, Cardinal, and AmerisourceBergen) should have received communications letters from them detailing their expectations and requirements. If you missed the communications, please read our blogs about them here:
- McKesson letters from January 2016 and March 2017
- Cardinal and AmerisourceBergen letters from April 2016 and February 2017
When you compare wholesaler requirements to FDA requirements, you can see clear alignment in the areas of serialization and serialized labeling, but discrepancy in the areas of aggregation and serialized data exchange. The latter is not a requirement by the FDA until 2023, but the big three need the data to perform returns verifications in 2019, four years ahead of the FDA plan. The FDA is aware of these discrepancies, and has referred to the wholesaler demand as a “business requirement.”
- Conform to industry standards: Partners in the pharmaceutical supply chain rely on standards to communicate with each other. The pharma industry in the U.S. solidified under the flagship of GS1 and had, meaning the standards you need to adhere to are these:
These standards are being adopted by the big three wholesalers. Through various communication letters and industry conferences, they have requested that their manufacturer suppliers align to the same. When the entire industry follows the same standard, it’s good for all involved as the same processes and data can now satisfy all trading partners.
- Register with GS1: When wholesale distributors speak about Global Trading Item Numbers (GTIN) and Global Location Numbers (GLN), they’re referring to the two data elements that make up the GS1 standard. To establish a GTIN and GLN, the first step is registering with GS1 for a company prefix. Remember to register for a GS1 company prefix with the embedded NDC number. It’s a U.S. DSCSA thing—the product identifier needs to contain the NDC number. GS1 provides registered companies with a company prefix, which can construct your GTIN number to include the NDC number, fulfilling FDA’s DSCSA requirement.
- Create master data: Prior to serialization, master data refers to the key data within your business system, such as lot, item number, and their attributes. With serialization, master data becomes more complicated. Master data now includes GTIN and GLN—both essential to serialization implementation. When integrating with your business partner for serialization, exchanging master data is often the first step that enables both business partners to speak the same language, or adopt the same single source of truth—one set of master data that both partners recognize and understand.
That’s a lot to think about! Next week we’ll review the second half of our DSCSA To-Do list.
Need DSCSA Help? Contact Us Today
Complying with regulations and meeting DSCSA standards is complicated. And ensuring you have the right systems and processes in place as you work toward compliance is vital for your success.
LSPediA understands the pharmaceutical supply chain. And we can ensure you understand and successfully implement a DSCSA strategy using our industry-tested serialization toolkits and our new, innovative traceability solution, Rx Chain. Need help? Contact us today.