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United States Regulatory

United States – Pharma Serialization & Traceability (DSCSA)

 
Regulatory Agency U.S. Food and Drug Administration (FDA) – oversees implementation and enforcement of the US Drug Supply Chain Security Act (DSCSA).
Regulation Name Drug Supply Chain Security Act (DSCSA)– Title II of the Drug Quality and Security Act (DQSA)
Regulatory framework for unit‑level serialization, electronic traceability, and interoperable data exchange.
Compliance Dates The DSCSA has a decade‑long phased rollout timeline with key enforcement milestones:
  • November 27, 2017: Manufacturers required to serialize each saleable unit with a unique identifier.
  • November 27, 2018: Repackagers serialization compliance.
  • November 27, 2023: Full serialized item‑level traceability and interoperable electronic data exchange requirements go into effect.
  • November 27, 2025: DSCSA adds serialized product identifier to standardized transaction information (enhanced reporting).
Applies to Prescription pharmaceutical products distributed in the US supply chain (manufacturers, repackagers, wholesale distributors, dispensers/pharmacies, and 3PLs).
Specific product exclusions apply (e.g., some non‑covered products like OTCs, animal drugs).

Secondary Packaging

 
Barcode Symbology GS1 2D DataMatrix for unit serialization (encodes the DSCSA product identifier).
Barcode Content Encoded product identifier must include:
  • GTIN (NDC embedded)
  • Unique Serial Number
  • Lot/Batch Number
  • Expiration Date.
Serial Number Randomization Yes — unique and unpredictable serial number per unit
Serial Number Reuse Not permitted — serials must be unique and not reused.
Human Readable Expiry Date Format Required on packaging (expiration date visible to humans).
Barcode Data Encoding GS1 Application Identifiers (e.g., 01, 21, 10, 17) per GS1 guidelines.
Product Code Notes GTIN is often derived from the National Drug Code (NDC) plus company prefix; used as the base for serialization.
Free Samples must be marked? Not specified by DSCSA — serialization applies to products entering the US supply chain.Free samples dispensed outside distribution are regulated but typically don’t require serialization if not entering the supply chain.

Tertiary Packaging

 
Barcode Symbology Cases and pallets typically carry GS1‑128 labels with SSCC for logistics.
Barcode Contents SSCC and optional case-level GTIN for aggregated units.

Aggregation Data Capture

 
Parent-Child Mapping Aggregation Capture? Optional — not required, but recommended for efficient scanning and management.

Data Exchange

 
Send Unit Data to Government Repository? No centralized US government repository.
Send Unit Data to Third-Party Repository? Optional — many trading partners use third‑party services.
Send Unit Data to Trading Partner? Yes — companies must exchange Transaction Information (TI), Transaction Statement (TS), and Transaction History (TH) electronically.
Send Aggregation Data to Government Repository? Not required.
Send Aggregation Data to Third-Party Repository? Industry practice
Send Aggregation Data to Trading Partner? Industry practice

Authentication

 
Who Offers Data Repository for Authentication? No national repository; verification often done via internal or third‑party systems (e.g., EPCIS platforms, Verification Router Service (VRS)).
Manufacturers Must Register Shipments in Repository? No government repository — but manufacturers must maintain detailed records
Downstream Trading Partners Must Authenticate on Receipt? Yes — wholesalers and dispensers must verify product identifiers and transaction data as part of trading partner requirements.
Downstream Trading Partners Must Authenticate on Shipment? Yes — verification is part of transaction documentation and ownership transfer under DSCSA.

Government Reporting

 
Manufacturer Activity Reported? Yes — manufacturers must generate, store, and share serialized data with partners.
Downstream Trading Partner Activity Reported? Yes — trading partners must maintain and exchange TI/TH/TS data for all transactions for six years.
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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