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

Published: Mar 15, 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

As pharmaceutical supply chains move toward full electronic traceability, unit-of-use drug identification has become a critical focus under regulations like the Drug Supply Chain Security Act (DSCSA) in the U.S. and the Falsified Medicines Directive (FMD) in the EU.

The GS1 Tag Data Standard (TDS) defines how Electronic Product Codes (EPCs) are structured on RFID tags, ensuring standardized, interoperable, and efficient drug tracking at the individual unit-of-use level (i.e., the smallest saleable package of a drug, such as a vial, syringe, or blister pack).

This document provides a primer on EPC 1.x and 2.x encoding formats for unit-of-use pharmaceutical tagging, explaining how GTIN, serial numbers, expiration dates, and lot numbers are structured and why EPC 2.x is the preferred format for future compliance.

GS1 EPC Encoding for Unit-of-Use Pharmaceuticals

GS1 defines two primary encoding versions for unit-of-use drug identification:

1. EPC 1.x (Older, widely adopted but traditionally database-dependent)
2. EPC 2.x (Enhanced, self-contained, and future-proofed for compliance)

Each version specifies how product data is encoded on RFID tags, impacting real-time verification, regulatory compliance, and supply chain interoperability.

1. EPC 1.x Encoding for Unit-of-Use Drugs

EPC 1.x formats provide basic serialization for pharmaceuticals, but they lack embedded expiration and lot number details in the standard EPC memory, requiring external databases for full drug identification[1].

However, an enhanced approach, SGTIN-96+, allows expiration and lot number storage in the tag’s user memory, addressing this limitation.

SGTIN-96 (Serialized GTIN)

• Format: 96-bit EPC
• Data Encoded in EPC Memory:
  • GTIN (Global Trade Item Number, 14 digits)
  • Unique Serial Number (38-bit)
• How it Works:
  • The GTIN identifies the drug product (e.g., a 50mg vial of a specific medication).
  • The serial number uniquely identifies each unit of that product.
  • Expiration date and lot number are NOT stored in EPC memory—they must be retrieved via an external system[2].

Limitations of Standard SGTIN-96 for Pharmaceuticals

✔ Provides unique serialization for each unit

✖ Requires database lookup to retrieve expiration date and lot number

✖ Slower authentication in offline scenarios

✖ Less efficient for DSCSA and FMD compliance

SGTIN-96+ (SGTIN-96 with Additional Data in User Memory)

To address SGTIN-96’s limitations, SGTIN-96+ extends the standard EPC by storing additional drug details in the tag’s user memory[3].

• Format: 96-bit EPC + Additional Data in User Memory
• Data Encoded in EPC Memory:
  • GTIN
  • Serial Number
• Data Encoded in User Memory (UM):
  • Expiration Date (YYYYMMDD format)
  • Lot Number
  • Optional Additional Regulatory Data

How SGTIN-96+ Improves Pharmaceutical Tracking

✔ Enables full offline verification—expiration and lot number are available without database lookups.

✔ Improves DSCSA compliance by eliminating third-party system reliance.

✔ Maintains backward compatibility with existing SGTIN-96 RFID readers while adding user memory functionality[4].

While SGTIN-96+ is a significant improvement, it does not provide as much standardization as EPC 2.x since user memory formatting can vary between implementations.

2. EPC 2.x Encoding for Unit-of-Use Drugs

EPC 2.x encoding formats were introduced to address the shortcomings of EPC 1.x, providing full serialization and product traceability within the EPC memory itself, without reliance on user memory or external databases.

SGTIN-198 (Serialized GTIN with Full Drug Data)

• Format: 198-bit EPC
• Data Encoded:
  • GTIN (Global Trade Item Number, 14 digits)
  • Unique Serial Number (Up to 88-bit)
  • Expiration Date (20-bit, YYYYMMDD format)
  • Batch/Lot Number (Up to 60-bit)

Comparison: SGTIN-96 vs. SGTIN-96+ vs. SGTIN-198

SGTIN-96+ provides a practical improvement over SGTIN-96, but SGTIN-198 is the superior solution for global compliance and future scalability.

Conclusion

SGTIN-96+ offers a short-term solution by storing expiration and lot number in user memory, removing database reliance. However, for long-term compliance and interoperability, SGTIN-198 (EPC 2.x) is the superior choice[5].

By adopting EPC 2.x encoding, pharmaceutical companies can ensure:

✔ Seamless DSCSA compliance

✔ Faster, offline drug verification

✔ Improved security and anti-counterfeiting measures

✔ Future-proofed track-and-trace capabilities

Footnotes

1. GS1. “Tag Data Standard (TDS) for Pharmaceuticals.” GS1.org, https://www.gs1.org/standards/tds

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

3. RAIN RFID Alliance. “Optimizing RFID Tag Memory for Pharmaceuticals.” RAINRFID.org, https://rainrfid.org

4. GS1 Healthcare. “EPC 2.x: Enabling Serialized Track-and-Trace for Pharmaceuticals.” GS1 Healthcare Report, https://www.gs1.org/industries/healthcare

5. Fresenius Kabi Plus RFID Program. “Unit-Level RFID in Pharmaceuticals.” PlusRFID.com, https://www.plusrfid.com/about