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As the U.S. drug supply chain grows more automated, the FDA is proposing a shift from the current 10- and 11-digit National Drug Code (NDC) formats to a standardized 12-digit structure. This change is driven by the looming exhaustion of 5-digit labeler codes and aims to enhance clarity, automation, and long-term sustainability. NDC 12 adopts a fixed 6-4-2 segment format, enabling better compatibility with GS1 standards, improved barcode readability, and seamless integration with traceability systems. The transition, expected to begin in 2025, will impact barcoding, GTINs, and data processing systems-requiring healthcare organizations to start preparing now.

As pharmaceutical supply chains shift toward unit-level traceability under regulations like DSCSA and the FMD, the structure of RFID-encoded drug data is becoming crucial. This post explains how GS1’s EPC encoding formats—SGTIN-96, SGTIN-96+, and SGTIN-198—impact drug serialization and compliance. While SGTIN-96 requires external databases, SGTIN-96+ adds expiration and lot number data to user memory for offline verification. However, EPC 2.x’s SGTIN-198 format fully embeds all critical data within the tag itself, offering the most standardized, compliant, and future-ready solution. For long-term interoperability and regulatory alignment, EPC 2.x is the recommended path forward.

To meet the stringent tracking requirements of the Drug Supply Chain Security Act (DSCSA), pharmaceutical companies must adopt secure and interoperable product identification systems. This blog post outlines how open RFID standards—specifically GS1 EPC and RAIN RFID—enable scalable, compliant drug serialization across the entire supply chain. GS1 embeds complete product data directly on RFID tags, eliminating database dependencies and simplifying compliance. RAIN RFID offers a hybrid model using third-party lookups while maintaining global compatibility. Compared to proprietary systems, these open standards reduce vendor lock-in, enhance transparency, and ensure long-term regulatory alignment—especially critical as the DSCSA 2024 electronic tracing deadline nears.

RFID technology is revolutionizing pharmaceutical supply chains, but its impact depends heavily on how drug data is encoded on RFID tags. This blog post explores three primary encoding methods—license plate, RAIN, and GS1—and compares their benefits and limitations. While license plate and RAIN models offer cost savings and moderate interoperability, they rely on external databases, creating long-term challenges. The GS1 standard, by contrast, embeds key drug details directly in the tag, enabling seamless, standards-based tracking across systems. For pharmaceutical companies aiming to future-proof operations and meet global regulatory requirements, GS1 offers the most scalable and interoperable solution.

RFID technology is revolutionizing pharmaceutical supply chains by enabling automated, accurate, and secure tracking of drug products. Unlike barcodes, RFID tags can be read in bulk, at a distance, and without line-of-sight, making them ideal for improving inventory management, verifying authenticity, and ensuring regulatory compliance. This introductory blog post breaks down how RFID works, the different types of tags, and why it’s especially valuable in meeting U.S. DSCSA and EU FMD requirements for unit-level traceability. As the series continues, it will explore how RFID supports compliance, standardization, and practical implementation across healthcare logistics.