This page provides information on how to work with us if you experience any data issues related to the new federal DSCSA law. The intended audience for this information includes direct purchasing customers of Genentech who fall within the DSCSA guidelines.
The Drug Supply Chain Security Act (DSCSA) is a U.S. federal law designed to enhance the security and traceability of prescription drugs throughout the supply chain. The law requires the use of product identifiers to verify the legitimacy of drugs at the package level when shipping from Genentech to our direct purchasing customers, including licensed dispensers.
The Genentech Data Issues and Resolution Policy was created to help our customers understand how to comply with reporting and resolution requirements per the federal law.
To learn more about DSCSA, visit the FDA website.
Please see the Genentech USA DSCSA Data Issues and Resolutions Policy.
Important Note: It is critical to report data errors immediately upon receipt to Genentech and appropriately store products until the error is resolved.
Full details can be found on the policy.
The DSCSA utilizes the Transaction Statement for shipping parties to notify recipients they are fully complying with the DSCSA through verbiage on packing lists and related electronic files. Genentech includes a transaction statement on every shipment and related electronic files (ASN and for customers requesting EPCIS) to confirm that we are in compliance with the DSCSA.
Our transaction statement states that: “Genentech has complied with each applicable subsection of FDCA Section 581 (27) (A)-(G)”
Note: This applies to direct receipts from Genentech, for any product received through distribution organizations, you should contact the providing organization for any questions on their transaction statement compliance.
Genentech DSCSA Technical Team: [email protected]
Genentech Customer Service: 800-551-2231 | Monday – Friday 6 am – 5 pm PT (9 am – 8 pm ET)
Counterfeit inquiries should continue to be routed to the US Drug Safety Product Quality Department
To learn more about the Drug Supply Chain Security Act Requirements, please refer to the FDA website.
The Genentech USA Return Goods Policy is out of scope of DSCSA orders and returns.