Onelign DSCSA Solution


Are you prepared for Nov 2023 DSCSA compliance deadline?


Ready Platform
to invite partners


APIs to collect and
publish data


Blockchain for
secure traceability

What are DSCSA Requirements?

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.
DSCSA compliance requires the following:

Interoperable Data Exchange

All-electronic, interoperable data exchange is the core of the FDA’s Enhanced Drug Distribution Security (EDDS) initiative. Trading partners must be able to exchange required Transaction Information (TI) and Transaction Statements (TS) in a secure, electronic, interoperable manner

Interoperable Verification

All trading partners—including dispensers—must have the ability to verify a suspect or illegitimate product identifier upon request from a trading partner, federal agency, or state agency or to submit a request for verification from a trading partner. As verification is expected at the serialized package level, this requires a highly scalable solution that can capture and process large volumes of serialized product data  within the mandated 24-hour response time  

Interoperable Tracing

Beginning on November 27, 2023, T3 information (Transaction Information, Transaction Statement, and Transaction History) will be only available electronically. Dispensers are also required to capture and maintain all Transaction Information and Transaction Statements for not less than 6 years. The FDA will not grant immunity after November 27, 2023, to drug supply companies who are not phase II ready. 

What does DSCSA 2023 compliance mean?

This means that companies need to be compliant in order to distribute drugs in the United States.   Companies who are not compliant will no longer be allowed to distribute drug products.

Who needs to comply?

The act requires all trading partners to be able to track and trace the transaction history of every medication that passes through to pharmacy to the end patient. The Drug Supply Chain Security Act (DSCSA) outlines product tracing requirements for manufacturers, repackagers, wholesale distributors and dispensers (pharmacies).

What is the urgency?

By November 27, 2023, all authorized trading partners will be required to implement an interoperable exchange, interoperable verification and interoperable tracing.


How can BONbLOC help?

We have the tools, technology and people to support rapid implementation of solution to comply with FDA requirements within the deadline.
DSCSA Requirement BONbLOC Solution Available
Exchange Exchange T3 data with all trading partners in a common platform
Interoperable Verification Data verification using GS1 or other standards
Interoperable Tracing Serialized lot tracing: one level or  end-to-end
Our solution uses blockchain technology as a default data storage in order to ensure immutability and provenance.

Unlock $$$ in supply chain value

Retain Customers, Reduce Financial and Compliance risks by tracing your Edge or End-to-End supply chain data using our Mobile & SaaS platform powered by IOT, Blockchain and AI.

Onelign DSCSA Solution

Asembia 2023 - Speciality Pharmacy Summit

Las Vegas, Nevada

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