Essential Guidance for Pharmaceutical Companies Adapting to New Serialization Requirements

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Introduction: A Pivotal Moment for Pharmaceutical Identification

The pharmaceutical industry stands at a crossroads. Two major regulatory shifts are converging to reshape how drug products are identified, tracked, and verified throughout the distribution network. Understanding these changes and implementing compliant systems is no longer optional—it’s a fundamental requirement for market access.

The Drug Supply Chain Security Act’s enhanced traceability mandates have moved from planning phase to full operational reality. At the same time, the Food and Drug Administration is overhauling the National Drug Code structure, expanding it from its traditional format to accommodate future growth. These parallel transformations create both technical challenges and opportunities for companies willing to invest in robust identification infrastructure.

This article provides practical guidance for pharmaceutical manufacturers navigating this transition, with specific focus on how to properly construct Global Trade Item Numbers that meet both current compliance requirements and prepare for the expanded NDC format coming in the next several years.

Continue reading Navigating GTIN Standards for NDC Compliance: Your 2025-2026 Roadmap →

Iowa lawmakers are tackling a $20 billion blind spot in pharmaceutical regulation—and the implications reach far beyond state borders.

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A Compliance Revolution Brewing in the Heartland

When most people think about pharmaceutical regulation, they picture traditional pharmacies with their familiar orange prescription bottles and white-coated pharmacists. But there’s a massive segment of the healthcare industry dispensing prescription medications with virtually no oversight: medical spas and wellness clinics.

Iowa is about to change that equation dramatically.

Continue reading Iowa’s Med Spa Compliance Revolution: What HSB 591 Means for You →

The Real Cost of DSCSA Compliance

Here’s a number that should get your attention: $5,000 to $20,000. That’s what most pharmaceutical organizations pay compliance consultants to develop a single DSCSA Standard Operating Procedure.

And that’s just the beginning. Add in 3-6 months of your team’s time, countless revision cycles, legal reviews, and the constant anxiety of wondering if you’ve covered everything the FDA expects to see.

Now imagine this scenario: FDA inspectors arrive at your facility for an unannounced inspection. Within the first hour, they ask to review your Drug Supply Chain Security Act procedures. You hand over what you have—maybe it’s outdated, maybe it’s incomplete, maybe it’s a patchwork of documents you’ve been meaning to organize.

Continue reading Free DSCSA SOP Generator: Create Audit-Ready Documentation →

The Drug Supply Chain Security Act (DSCSA) has transformed the way prescription drugs move through the U.S. supply chain. At the core of this transformation is the Electronic Product Code Information Services (EPCIS)standard, which ensures the interoperable exchange of serialized data at the package level.

But even in a fully digital ecosystem, problems can and do arise. 

Continue reading EPCIS Exception Handling: Building a Resilient DSCSA Supply Chain →

With the final DSCSA exemption deadline looming in May 2025, pharmaceutical manufacturers must act now to comply with the FDA’s interoperability, serialization, and traceability mandates. Non-compliance isn’t just a regulatory headache—it can cause severe disruptions, including halted product sales, costly recalls, and damaged supply chain relationships.

Continue reading DSCSA Compliance: Essential Steps for Manufacturers →

The Drug Supply Chain Security Act (DSCSA) compliance deadlines are fast approaching. Despite the political landscape’s recent shifts, these deadlines remain firmly in place. The regulatory freeze introduced by the Trump administration in January 2025 has generated discussions, but it does not alter these legally mandated timelines. Businesses must continue their preparations to ensure compliance.

Continue reading Regulatory Freeze Under the New Trump Administration: Implications for DSCSA Compliance →