Open RFID Tag Standards and DSCSA Compliance

Published: Mar 10, 2025 by

RFID Basics For Pharma

• A Primer on What RFID Is and How It Works
• RFID in Pharmaceuticals

• Open RFID Tag Standards and DSCSA Compliance

• GS1 Tag Data Standard (TDS) for Unit-of-Use Pharmaceuticals

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, establishes a nationwide system for tracking prescription drugs throughout the supply chain to enhance patient safety, reduce counterfeit risks, and improve regulatory oversight. One of the key challenges in meeting DSCSA requirements is ensuring secure, standardized, and interoperable product identification across all stakeholders—including manufacturers, wholesalers, pharmacies, and healthcare providers.

To address these challenges, open RFID tag standards such as GS1’s EPC format and the RAIN RFID framework provide global compatibility, transparency, and interoperability. These standards eliminate reliance on proprietary databases, enabling seamless data exchange while ensuring compliance with DSCSA mandates.

In this document, we will explore how GS1 and RAIN RFID support DSCSA compliance and why open standards provide a more sustainable and scalable solution compared to proprietary, closed-loop systems.

Why Open RFID Standards Matter for DSCSA Compliance

Open standards such as GS1 and RAIN RFID enable a universal approach to drug serialization and tracking, ensuring pharmaceutical supply chains remain transparent, efficient, and interoperable. These standards provide:

• A globally recognized, structured data format that ensures consistent product identification.
• Interoperability across multiple stakeholders without vendor lock-in.
• Reduced dependency on proprietary third-party databases, making DSCSA compliance more efficient and scalable.

1. GS1: A Fully Open Standard for Serialized Drug Tracking

The GS1 EPC standard is the most widely adopted global framework for identifying, capturing, and sharing serialized drug information. It aligns directly with DSCSA by encoding key drug details within the RFID tag, including:

• Global Trade Item Number (GTIN)
• Expiration Date
• Lot Number
• Serial Number (if applicable)

This self-contained encoding approach eliminates the need for external databases and allows any DSCSA-compliant system to read and process the tag’s data without proprietary restrictions.

How GS1 Supports DSCSA Compliance

1. Standardized Serialization
   • DSCSA mandates unit-level serialization for tracking individual drug packages.
   • GS1’s EPC format ensures each unit has a globally unique identifier, reducing risk of counterfeits and enabling instant verification.
2. Interoperability Across Supply Chain Partners
   • Because GS1 is an open standard, it ensures seamless data exchange between manufacturers, distributors, and pharmacies—without reliance on proprietary solutions.
   • Any system that supports GS1 RFID tagging can read and interpret the data, simplifying compliance.
3. No Proprietary Database Lookup Required
   • Unlike closed-loop RFID solutions that require external third-party validation, GS1-encoded EPC tags store all required product information directly on the tag.
   • This ensures faster verification, fewer bottlenecks, and lower costs** for DSCSA compliance.
4. Regulatory Alignment
   • GS1’s EPC format aligns with FDA serialization guidelines and supports track-and-trace systems mandated under DSCSA[1].
   • Manufacturers and wholesalers using GS1-compliant RFID are already positioned to meet DSCSA 2024 electronic tracing requirements[2].

2. RAIN RFID: Enabling Scalable, Third-Party Data Lookup

The RAIN RFID standard, which is built on EPC Gen2 UHF RFID technology, is another open framework supporting DSCSA compliance. RAIN differs from GS1 in that it relies on a hybrid approach, using:

• Company-specific EPC identifiers
• Encodings that reference third-party databases for drug details

While RAIN RFID still follows an open structure, it requires access to a separate system to retrieve full product details. Companies like Cencora (formerly AmerisourceBergen) have implemented RAIN-based solutions, allowing third-party lookups for drug verification and traceability[3].

How RAIN RFID Supports DSCSA Compliance

1. Industry-Wide Compatibility
   • RAIN follows EPC Gen2 standards, ensuring global compatibility across DSCSA-regulated pharmaceutical supply chains.
2. Scalable Data Storage
   • By storing only partial product identifiers on the tag, RAIN RFID allows external databases to maintain detailed product records.
   • This approach enables scalable serialization without increasing RFID tag memory costs.
3. Flexible Lookup via Third-Party Databases
   • Unlike GS1’s self-contained encoding, RAIN RFID requires database access to retrieve full drug details, lot numbers, and expiration dates.
   • This enables dynamic updates but introduces a dependency on external systems.
4. DSCSA Alignment
   • Manufacturers and distributors leveraging RAIN RFID can meet DSCSA tracking mandates by ensuring database-backed serialization and verification[4].

3. Open Standards vs. Proprietary RFID Solutions

Some pharmaceutical supply chain solutions rely on proprietary, closed-loop RFID tagging systems that:

• Require exclusive database access to resolve product details.
• Introduce vendor lock-in, restricting flexibility across supply chain partners.
• Slow down interoperability by limiting real-time product verification.

Why Open Standards (GS1 & RAIN) Are Superior

✔ Regulatory Compliance: GS1 and RAIN RFID align with DSCSA, ensuring future-proof compliance.

✔ Universal Compatibility: Any DSCSA-compliant organization can use open-standard RFID for seamless tracking.

✔ Elimination of Vendor Lock-In: GS1 EPC allows free data access, while RAIN provides flexible lookup options.

✔ Lower Long-Term Costs: Open RFID standards reduce reliance on costly third-party data validation.

Conclusion

Adopting open RFID standards such as GS1 EPC and RAIN RFID is the most effective way to ensure DSCSA compliance while maintaining interoperability across the pharmaceutical supply chain. These standards provide:

• Transparent, serialized drug tracking
• Regulatory alignment with DSCSA and global serialization laws
• Reduced reliance on proprietary data systems
• Future-proof scalability for emerging technologies like blockchain and AI-driven supply chain analytics

As the DSCSA 2024 electronic tracing deadline approaches, pharmaceutical manufacturers and distributors should prioritize open, standards-based RFID solutions to ensure long-term compliance, efficiency, and supply chain security.

Footnotes

1. GS1 Healthcare. “GS1 Standards and DSCSA Compliance.” GS1.org, https://www.gs1.org/standards/tds ↩

2. U.S. Food & Drug Administration. “DSCSA Overview.” FDA.gov, https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa ↩

3. Cencora/AmerisourceBergen. “RFID for DSCSA Compliance.” AmerisourceBergen.com, https://www.amerisourcebergen.com/pharmaceutical-distribution/rfid-data ↩

4. RAIN RFID Alliance. “RFID Standards for Pharmaceutical Supply Chains.” RAINRFID.org, https://rainrfid.org ↩