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DSCSA: All Regulations and No Standards? Yes, But…

By August 24, 2016March 2nd, 2021DSCSA, Serialization, Track and Trace

The DSCSA is bringing badly needed regulations to the pharmaceutical industry. While the primary goal of those regulations is improving patient safety, as an added benefit it’s also forcing the industry’s supply chain to step up its game and adopt modern tools and processes.

So we have (or will have, once all the regulations are in place) a lot to thank the FDA for: Better patient outcomes. Fewer tainted and counterfeit drugs on the market. More efficient manufacturing and distribution methods. Plus better business outcomes via more efficiencies.

But the industry has a complaint, too – a valid one: The regulations give us a mandatory goal to reach but no directions for getting there.

Enter GS1, a global developer of standards. But it’s surprising to me how many business owners in our industry are unfamiliar with what this organization is and how much it is contributing to a smooth-ish implementation to DSCSA compliance. While we at LSPediA have long recognized their efforts, even I didn’t realize just how big an impact GS1 is having on the work we all do. Having recently been asked to join the GS1 Healthcare initiative and participate in their workgroups, I now see these efforts up close and recognize that all these would be in vain if the industry fails to adopt the standards.

As a supporter of GS1, I encourage my readers and my fellow pharmaceutical peers to explore GS1 and their standards.

Standards are a Group Effort

GS1 Healthcare U.S.

This group “brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States” and “…supports the adoption and implementation of global standards developed by GS1.”

Patient safety and an improved supply chain: Everything GS1 Healthcare U.S. does stems from those two objectives. Neither can’t be accomplished without collaboration from trading partners. And trading partners can’t collaborate without a common business language – industry standards. Thanks to GS1, a foundation of trustworthy transaction data has been built that allows trading partners to exchange millions of products. This foundation includes:

  • Standardized product identification (GTIN)
  • Standardized location identification (GLN)
  • Standardized product definition (GDSN)

GS1 Healthcare U.S. believes that the adoption and implementation of GS1 Standards in the healthcare industry can improve patient safety and supply chain efficiency. To that end, and with the help of industry collaboration, they are focused on these five implementations:

  1. Identify and Capture – Barcodes and RFID
  2. E-Commerce – EDI/XML transactions
  3. Electronic Record Management – e-records and e-prescription
  4. FDA Compliance – UDI and DSCSA
  5. Traceability – Track-n-trace, recalls, assets and equipment tracking

How You’re Impacted

That all sounds great, but you might wonder, “What’s in it for me?” If your work is related to DSCSA serialization, then the answer is “everything.” Unless you make, distribute, and consume your products all by yourself without any trading partners, GS1 standards have a huge impact on you and your business.

Think about how deeply GS1’s standards are integrated into our business. Similar to the FDA labeler code, NDC code, and UPC code, the industry is adopting GS1’s location identification, product identification, barcode standard, the EPC Tag Data Standard, the Tag Data Translation Standard, the EPCIS Standard, and the Core Business Vocabulary Standard. That’s why a DSCSA serialization project can’t be done without working with some GS1 standards.

For many, the paragraph above is overwhelming. I get it. Unless you’re an engineer or work in a technical position, these standards are not everyday conversation topics. For the day-to-day business, GS1 simple means a standard that enables the recording and tracking of serialized products when they move through the supply chain. And if you don’t remember anything else, remember that GTIN is the “new” NDC, and GLN is the “new” zip code.

How to Get Started

Complying with regulations and meeting standards in the pharmaceutical industry is a complicated task. It’s also one of the most important tasks your business undertakes. Your reputation with partners and patients, and your bottom line, are all at stake.

If you need a guide to get you started and see you through to DSCSA compliance, please consider LSPediA. We can ensure you understand and successfully implement GS1 standards, a DSCSA strategy, and serialization solutions. Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact us today.


About LSPediA

LSPediA helps pharmaceutical manufacturers and distributors plan, design, and implement processes and solution to meet serialization global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include serialization gap analysis, strategic planning, solution architecture, vendor selection, line execution, CMO management, supplier management, implementation, 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.