DSCSA Compliance Strategies: How Business Networks Are Transforming Pharma Logistics

As the pharmaceutical industry edges closer to the updated compliance deadlines for the U.S. Drug Supply Chain Securities Act (DSCSA), the pressure to act has never been greater. While some organizations have successfully navigated the complexities of serialization and traceability, many still face significant challenges. In this guest article, Aladdin Mandishah, Director of Product Marketing for SAP’s Life Sciences & Healthcare business unit, provides actionable insights into how DSCSA-compliance serialization networks can streamline processes, enhance safety, and mitigate risks.

By joining established DSCSA business networks, organizations can not only meet compliance requirements but also unlock operational efficiencies and safeguard against future disruptions. Read on to discover the strategies and technologies leading the way toward full DSCSA readiness.

The clock is ticking on DSCSA compliance. Follow the leaders to a business network.

By Aladdin Mandishah

In early November, the question on the minds of everyone in pharma logistics: “One month away from DSCSA deadline: Is the pharmaceutical industry ready?”

The topic was, of course, the U.S. Drug Supply Chain Securities Act; and the answer was an emphatic “no.” Fortunately for the industry, the November in question was back in 2018. Six years later, despite much progress, the answer remains the same.

Much of the industry has come to terms with the serialization, barcoding, and other challenges that stymied so many in the years after the DSCSA became law in 2013. The U.S. Food and Drug Administration had given extension after extension when, this past Oct. 9, it offered yet another reprieve. The FDA had little choice. In its own words, it was trying to “avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.”

FDA leaders offered automatic extensions to those who have at least started along the path of having “successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.” The universal November 27, 2024 deadline became May 27, 2025 for manufacturers and repackagers; Aug. 27, 2025 for wholesale distributors; and Nov. 27, 2025 for dispensers with 26 or more full-time employees (dispensers with 25 or less employees have until Nov. 27, 2026). So, what can those who have yet to comply with DSCSA learn from those who are ready to go?

Join a DSCSA “club”

The DSCSA pioneers, led by the household-name pharmaceutical companies in collaboration with major business software developers, have already done most of the hard work. They’ve created DSCSA-focused business networks that cover the law’s functional requirements (as well as the requirements of similar laws such as the EU Falsified Medicines Directive) and enable smooth onboarding of new participants.

Joining such a serialization network has the immediate benefit of standardized integration – thereby avoiding the expensive tedium of having to develop custom interfaces with what could be dozens of trading partners. Once integrated, you’re automatically plugged in with all who came before – which include all the pharmaceutical giants and the largest wholesalers.

Think of these DSCSA serialization networks as communication gateways. They’re agnostic with respect to the underlying enterprise resource planning (ERP), warehouse management system, and other business systems which, as systems of record, should store and manage serialization data.

What to look for in a DSCSA-compliance serialization network

What should you look for in a DSCSA business network? The law’s principal goal was to make pharmaceuticals safer for patients by starkly improving traceability and thereby keep counterfeit, stolen, contaminated, or harmful drugs from entering the supply chain. A company’s DSCSA goals will devolve from that, and they start with avoiding the costs of noncompliance. But, just as importantly, they typically include preventing financial losses through drug counterfeiting, theft-related shrinkage, and the high costs and reputational damage of product recalls.

But there are other gains to be had. SAP estimates that a DSCSA serialization network can reduce the risk of quality noncompliance by 3-10%, cut compliance-management costs 2-5% through automating and simplifying data exchange and regulatory reporting, and reduce days in inventory 1-2% by improving data integrity and automating data exchange and exception handling to ensure accurate inbound receipt of products.

How a DSCSA serialization network gets you there

Achieving those sorts of results obviously takes more than the basic requirement of properly serializing each package and case of prescription drugs with a unique 2D data matrix barcode containing Global Trade Item Number, serial number, lot number, and expiration date.

Mature DSCSA serialization networks include verification routing services with trading partners with transaction information and transaction statements. They enable accurate and timely reporting of suspect or illegitimate products. Critically, they can manage exceptions such as missing or inconsistent data quickly and accurately, saving on the slow, labor-intensive legwork of manual exception handling and the supply chain disruption that can result. Looking ahead, these serialization networks will be able to use generative artificial intelligence (GenAI) to reclassify and, if desired, resolve data and product issues within the network, stabilizing the supply chain.

Fortunately for those working on DSCSA compliance, it’s not 2018 anymore. But time is now short, and given the industry’s progress at this point, betting on another FDA extension would be unwise. The pioneers have long since established the way forward through business networks that are already managing millions of serial numbers a monthly. Joining them is the best way forward.

Aladdin Mandishah is director of product marketing for SAP’s Life Sciences & Healthcare business unit.