DSCSA Regulations

Pulse by NABP is an inclusive, accessible, and secure digital platform that simplifies DSCSA compliance.

NABP has a 120-year history of solving complex regulatory challenges to meet its mission of protecting public health. After the Drug Supply Chain Security Act (DSCSA) was signed into law in 2013, we explored its impact on regulators and trading partners across the pharmaceutical supply chain through pilot programs and industry-wide discussions. 

What DSCSA Compliance Involves

The November 2023 final DSCSA milestone, following a 10-year phased implementation approach, requires trading partners to participate with one another electronically in an interoperable fashion to enable prescription drugs to be tracked through the supply chain. FDA issued a 1-year stabilization period for all stakeholders to implement and normalize systems and processes prior to the expected full enforcement starting November 27, 2024. In June 2024, FDA issued exemptions for certain dispensers and in limited scenarios, their trading partners, from section 582 under the FD&C Act until November 27, 2026. FDA issued additional waivers and exemptions in October 2024 as trading partners work towards fully implementing DSCSA requirements.

Authorized Trading Partner Transactions

Members of the drug supply chain may only transact with authorized trading partners (ATPs). 

Suspect/Illegitimate Product Handling

Trading partners must develop a process for dealing with products where there is a reasonable belief that the product may be illegitimate, as defined by DSCSA. If a determination is made that a drug is considered illegitimate, trading partners must comply with specific requirements to protect patients.

Electronic T3 Information Distribution

Upstream supply chain members must distribute electronic transaction information, transaction history, and transaction statements (commonly referred to as T3 information) to downstream partners. 

Unique Product Identifiers

Each saleable unit must have a 2-dimensional product identifier that includes the National Drug Code (NDC), lot number, expiration date, and a unique serial number.

Pulse supports the industry by offering a comprehensive directory of trading partners, streamlining communication, and reducing administrative work – all within a secure, interoperable system. Pulse helps trading partners to fill gaps in the tools and processes needed to meet DSCSA requirements.