The Drug Supply Chain Security Act (DSCSA) requires electronic, interoperable systems to trace prescription drugs at the package level across the U.S. supply chain, aiming to prevent counterfeit, stolen, or harmful products from reaching consumers.

Here’s a breakdown of the key DSCSA requirements:

🏛️ Overview

  • Enacted in 2013 as Title II of the Drug Quality and Security Act (DQSA)
  • Applies to manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers
  • Full implementation deadline: November 27, 2023, with some exemptions extended into 2025–2026

🔐 Core Requirements

  1. Product Tracing
  • Trading partners must exchange Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) for each drug shipment
  • As of 2023, electronic-based tracing replaces paper documentation
  • By 2025, tracing must include serialized product identifiers at the package level
  1. Verification Systems
  • Partners must verify suspect or illegitimate products
  • Includes checking product identifiers and responding to FDA or trading partner requests
  1. Licensure and Reporting
  • Wholesale distributors and 3PLs must obtain national licensure and report status to the FDA annually
  1. Interoperability
  • All trading partners must use interoperable electronic systems to exchange data
  • FDA recommends using EPCIS (Electronic Product Code Information Services) standards

🧑‍⚕️ Dispenser Responsibilities

  • Only accept products with complete TI, TH, and TS
  • Engage only with licensed and registered trading partners
  • Maintain records for at least six years
  • Investigate and quarantine suspect products

📅 Compliance Timeline Highlights

Entity Type Full Compliance Deadline
Manufacturers/Repackagers May 27, 2025
Wholesale Distributors August 27, 2025
Large Dispensers* November 27, 2025
Small Dispensers** November 27, 2025

Sources: FDA DSCSA Law and Policies, ASHP DSCSA Requirements, McKesson DSCSA FAQs

*26 staff or more

**less than 26 staff

The UDI barcode is foundational to the DSCSA system. It must be present and it must work right. To work right, the barcode must meet two essential requirements:

  • It must achieve an ISO 1.5 (ANSI C) grade or better for print quality
  • It must comply with either the GS1 or the HIBC standard for data structure

Verification

A compliant barcode verifier tests and grades for these two essential attributes. The manufacturer or packager can do verification, or a contractor testing service can do it. We can help–Barcode Test LLC is an independent barcode quality and compliance testing lab.

Validation

Certain types of linear and 1D barcodes are acceptable data carriers for the DSCSA. It is important that a valid barcode type (symbology) is used, and that all trading partners in the supply chain are equipped to scan a specific symbology. Our testing identifies the symbology and tests it for UDI data structure compliance.

Questions? Comments? Contact us here.

 

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3db Barcode Testimonial

Our company (an advanced software company) recently worked with Barcode Test to source a barcode verifier.  Not long ago, we were awarded a contract requiring products to be marked with IUIDs in accordance with MIL-STD-130.  For that standard, marking labels must pass a verification test that evaluates many variables (contrast, size, clarity, syntax, modularity, and more).  After a thorough search, we reduced our options to a select few.

In our search for a verifier, the Axicon line caught our attention.  Barcode Test is our regional reseller for this product.   From the beginning, they were very prompt with their responses.  We ended up having a quick call with John Nachtrieb to go over our needs.  John was extremely easy to work with and provided a lot of great information.  He was very knowledgeable on the matter and was quick to offer up a demo unit (free of charge).

Upon receiving the demo verifier and testing it, a few questions arose.  John joined a call with us and answered all our questions.  Ultimately, the Axicon verifier wasn’t the best fit for us, so we shipped the demo back.  John was completely understanding.  A few weeks later, Barcode Test reached back out with another possible verifier for us to try.  While they didn’t sell that brand, they just wanted to help us find the best option that met our needs. They even offered to send us the unit that they have in-house to see if it worked to our liking. 

Barcode Test is truly a great company to work with.  Their service and willingness to help the customer are far beyond what you typically get from other companies.  They are experts in barcode quality assurance and seem willing to help in any way they can (even if that means not getting a sale and recommending another option that better fits the customer’s needs).  If anyone is in the market for barcode verification/scanning services or products, I would highly recommend giving Barcode Test a call.

Regards,

Production Manager