BONbLOC

DSCSA 2023 mandates that We offer

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. Our solution uses blockchain technology as a standard data store in order to ensure data immutability and provenance.

Interoperable Exchange: We have a ready platform that can be tailored to setup and onboard trading partners for drug supply chain, enabling immediate ability to exchange transaction data.
Interoperable Verification: We have a set of data exchange APIs that can be customized or tailored to work with GS1 or similar standard to enable verification of each shipment or receipt transaction.
Interoperable Tracing: Our solution allows end-to-end visibility using serialization and lot data so the entire transaction can be traced for one up and one back visibility or end to end visibility.

Services Team: Our DSCSA services team are trained to support large transaction sets resulting large supply chain community. Our services team can monitor and support verification.

We can mobilize a support team within 24 hours to help you start your compliance program.

How to contact us?

Please email your interest to dscsa23@bonbloc.com.
We will respond to you within 12 hours.

Contact us at: dscsa23@bonbloc.com

Services