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The DSCSA: 10 To-Dos, Part 2

By May 10, 2017March 16th, 2021DSCSA, Serialization

Note: Part 1 of this blog can be found here.

The DSCSA deadline is driving a lot of activity in the industry, but it doesn’t have to drive you to anxiety. Our check list will help you see where your business is on the road to compliance, but it also goes beyond the “whats” to give insight into the “whys” and “hows” of each crucial step. And if you have more questions, all you have to do is reach out to us.

Let’s get to work!

Five More To-Dos for Achieving DSCSA Compliance

6. Define a strategy: Where will you be in three years? Five years, 10 years? They say people over estimate what they can do in one year, but under estimate what they can in 10. Will your company grow, merge, divest, or exit? Do you want to be a small fish in big pond, or a big fish in a small pond? Are you doing this only for compliance, or for a competitive edge, or customer satisfaction? What other compliance components are in scope—maybe cGMP and Part 11 for example?

These are the important questions. And you need to have clear answers before you sign a contract with a serialization vendor. Solutions don’t make a business—people do. People align serialization to the company vision. They define scope and follow through. Without a strategy that lays out the end state, a serialization project can veer into unforeseen territory, and unintended misfortune.

7. Implement serialization: Everyone reading this should be well past the point of knowing if they need to serialize. It is unlikely that the new U.S. administration will revoke or make significant changes to the DSCSA rules—any changes have to go through congress. The FDA has no authority to change the law itself. The wiggle room they have delaying enforcement, as they did for the 2015 requirement, adding a five-month extension. So it’s not impossible the same could happen with the 2017 requirements. But would a five-month extension help anyone? Bottom line: Implement serialization now. With or without the delayed enforcement, you need all the time available to get this done.

8. Collaborate with CMOs: CMOs holds the key to serialization delivery. That’s because they have the responsibility to “affix to, or imprint upon, a package or homogeneous case” with the unique product identifier as described by the DSCSA.

However, CMOs don’t trade with wholesale distributors directly. That means their wholesale distributor knowledge is limited, and their insight into supply chain issues is basically nonexistent. Manufacturers have to step up, take the lead, and provide guidance to the CMOs. Don’t assume your CMO understands label processes and data requirements—don’t assume anything. All the risk—regulatory and business—ultimately lies with manufacturers. Collaboration is the key word, and they only way to ensure all partners contribute to the greater good of serialization.

9. Collaborate with 3PLs: Manufacturers and any of their supply chain partners not yet compliant must seek alternative means to comply with the regulations. A third-party logistics provider (3PL) is a sound option for filling in the gaps in this situation, especially the 3PLs who invested in aggregation and serialized shipment capabilities.

Remember that serialization does not run in silos: Every player in the supply chain is responsible for part of the requirement. Manufacturers and 3PLs need to collaborate to get there. When partners work closely together, it’s good for everyone’s business.

10. Coordinate with customers: That’s right—more collaboration! Wholesalers are just as anxious about serialization as manufacturers, if not more so. And they’re eager to communicate. Their label requirement and serialization survey for manufacturer suppliers started in 2014. Since then, the wholesale distribution community, led by the big three and the Healthcare Distribution Alliance (HDA), have issued communication letters every year.

HDA itself issues a serialization survey every September. The FDA and wholesale community need to understand the good, bad, and ugly. Whether or not manufacturers think they have “good” answers to those survey questions, they need to take part. Any information they have is important—even cryptic input could be shedding light on industry issues. Speaking up is always a good idea, as it could help solve problems for everyone, including the need for more compliance time.

We Can Help—Contact LSPediA Today

Six short months away from the DSCSA serialization deadline. Don’t let compliance gaps and system gaps disrupt your supply chain. If you’re worried, we can help. Our Traceability software, RxChain, can deliver the following capabilities in eight weeks:

  • Serial Data Repository – data exchange with line, CMOs, and wholesalers
  • Serial Warehouse Management – pick, pack, aggregated shipment, and reconciliation
  • Aggregation Station – aggregate unit-case, bundle-case, and case-pallet with ease

In addition, LSPediA provides strong consulting capabilities to drive:

  • Packaging line execution
  • IT solution deployment
  • CMO management
  • System integration

LSPediA understands the pharmaceutical supply chain. Simply reply to this email or call (248) 973-2008 to schedule your one-on-one meeting with us today.

 

About LSPediA – Life Sciences Solutions

LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.

For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com. For more details about the VAWD solution, please go to https://www.lspedia.com/vawd.