DSCSA Regulations and Compliance with RFID Technology

This legislation sets forth requirements for the pharmaceutical industry, which include tracking and tracing prescription drugs as they move through the supply chain. The DSCSA specifically targets manufacturers, repackagers, wholesale distributors, and dispensers, establishing guidelines for product verification, serialization, and data exchange.

But, why is this important now? There are three main phases of DSCSA – and the last phase is still ongoing, with estimated deadlines in 2025 and 2026.

The 3 Phases of DSCSA & What DSCSA Compliance Looks Like

Phase 1: Lot-Level Tracing

Objective: Establish traceability by requiring trading partners to exchange transaction level information (TI), transaction history (TH), and transaction statements (TS) at the lot level (or batch level). The initial phase of DSCSA is focused on establishing a mechanism to facilitate effective tracing and tracking of pharmaceuticals. By requiring trading partners to exchange transaction information, transaction history, and transaction statements, the act initiated a system for capturing data related to the origin and movement of pharmaceuticals within the supply chain.

Key Dates:

• January 2015 – TI, TH, TS information shared by manufacturers, wholesalers, and repackagers.
• July 2015 – TI, TH, TS information received by dispensers and pharmacies from all trading partners

What DSCSA Phase 1 Compliance Looks Like:

A paper or digital document containing:

• TI elements: proprietary name, dosage form, NDC, container size, etc.
• TH: Full movement history
• TS: Seller declaration of compliance

Phase 2: Serialization

Objective: Implement serialization by requiring unique product identifiers on prescription drug packages, enhancing traceability. and improved identification This phase emphasized the importance of unique identifiers for each package of medication. By 2017, manufacturers and repackagers were required to apply a unique serial number on each package in the form of a 2D data matrix barcode. Serialization allows for precise tracking of products, enabling stakeholders to quickly identify and rectify issues such as recalls or counterfeit drugs.

Key Dates:

• November 2017 – Manufacturers required to serialize prescription drug packages
• November 2018 – Repackagers required to serialize products
• November 2019 – Wholesalers and repackagers required to verify product identifiers before distribution
• November 2020 – Dispensers required to verify product identifiers and maintain TI, TH, and TS level data and records

What DSCSA Phase 2 Compliance Looks Like:

All of the elements of Phase 1, with the addition of a 2D Data Matrix barcode along with human readable information on each package and case of pharmaceuticals. The 2D Data Matrix barcode and human readable information both contain:

• GTIN
• NDC (National Drug Code)(Inside the GTIN)
• GS1 Company Prefix (Inside the GTIN)
• Indicator and Check Digit (Inside the GTIN)
• Serial Number
• Lot Number
• Expiration Date

Phase 3: Enhanced Drug Distribution Security (EDDS)

Objective: Achieve full interoperability by enabling electronic, package-level traceability across the entire supply chain. This final phase, aimed to be fully implemented by 2026, requires an advanced electronic system to enable unit-level tracing across the supply chain. This phase seeks to bolster the ability of trading partners to verify product legitimacy and exchange data using standardized, secure processes.

Key Dates:

• Original Deadline: November 2023
• Stabilization: November 2023 – November 2024
• Updated Deadlines: May–November 2025 for different stakeholders

What DSCSA Phase 3 Compliance Looks Like:

All of the elements from Phase 1 and Phase 2, as well as an interoperable data exchange software and standardized data for exchanging among trade partners.

• Interoperable Data Exchange Software – a way for all trading partners throughout the supply chain to exchange data electronically.
• Standardized Data for Exchanging – preferably EPCIS, a GS1 standard for exchanging product identification data along with event level data (i.e. the What, When, Where, Why). Each EPCIS “event” captures information like:
• What happened (e.g., shipping, receiving, packing)
• When it happened
• Where it happened
• Which product(s) were involved (via GTIN + serial number)
• Business process step (e.g., commissioning, shipping, aggregation)

This is what allows trading partners and the FDA to digitally trace a product's entire journey in real-time.

How RFID Supports DSCSA Compliance

RFID technology is widely used in healthcare for inventory and patient management. Adding RFID to DSCSA-compliant labels provides real-time traceability and efficiency advantages over 2D barcodes alone.

Product Authentication

Enhance product authentication to safeguard against pharmaceutical counterfeiting and tampering. Unlike 2D barcodes, RFID tags are significantly more difficult to replicate, offering a higher level of security and trust throughout the supply chain.

Faster Scanning

When companies throughout the supply chain receive products, RFID readers can be positioned at receiving points to automatically read the tagged inventory upon arrival. Each 2D barcode scan takes on average 1-2 second, while RFID readers can read 800 RFID tags per second – saving companies time and money.

Accurate Inventory

Inventory management is one of the most powerful applications of RFID technology across all industries. In the pharmaceutical sector, RFID readers automatically capture time-stamped data as they scan tagged products, streamlining inventory tracking with real-time accuracy. When RFID readers are strategically placed in inventory staging areas, they enable continuous monitoring—helping to maintain precise stock levels while reducing the risk of theft or loss.

Automate Manual Processes & Reduce Errors

RFID tag reads can be used to automate any manual processes that can be prone to user error. This can include product receiving, shipping, inventory counts, replenishment notifications, and locating specific products.

Product Recall Locating

If products are recalled, handheld RFID readers can be instrumental in locating recalled medication. Using a handheld RFID reader’s Geiger Counter, or proximity locator functionality, staff can walk through warehouses, hospitals, clinics, or storerooms and find all the products covered under the recall.

Hospital Interoperability

Because a large number of hospitals already use RFID for managing medication inventory (among other applications) pharmaceutical companies could integrate more seamlessly with hospital systems and data by adding RFID technology further up in the supply chain.

Implementing RFID Labels Alongside DSCSA Compliance

Because the cost of RFID labels has dropped significantly, most companies are able to swap out traditional labels for RFID labels for a relatively low cost.

1. Select RFID tags/labels with enough EPC memory for encoding the required product identifier data (GTIN, serial number, lot number, and expiration date). Also ensure the size of the label is big enough to hold the 2D Data Matrix barcode and human readable information.
2. Purchase an RFID-enabled printer or pre-printed and encoded RFID labels. Include a validation step during printing to ensure the encoded information matches the printed information exactly.
3. Update your serialization software to support RFID event capture and EPCIS data exchange. Your system must be able to generate, store, and share EPCIS events based on RFID reads, just like it would for barcode scans.
4. Purchase and implement RFID hardware depending on the additional internal applications your company would like to enable – i.e. fixed RFID readers and antennas for inventory management, handheld RFID readers for receiving inventory, etc.
5. Train your team on how to handle and verify RFID-labeled products and the RFID system(s).
6. Work with your trading partners to enable shared RFID tag read data (if applicable) throughout the supply chain.