Full serialization of the U.S. pharmaceutical supply chain is coming in November 2023. That may seem like a long way off, but time flies and it will be here before you know it. To help make sure you’re working toward that deadline and doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.
Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!
- Tuesday, June 15: The Verification Router Service: Aligning to the Standard
- Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
- Thursday, June 17: Authorized Trading Partners: The OCI Solution
Here’s a sneak peek about the DSCSA Verification Router Service (VRS). Check back for more sneak peeks leading up to Brian’s other presentations in our rfxcel DSCSA 2023 webinar series!
What is the DSCSA?
The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization will begin in November 2023 (the 27th, to be exact).
What is the DSCSA saleable returns verification requirement?
Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI, which comprises a Standardized Numerical Identifier (National Drug Code and a unique alphanumeric serial number), a lot ID, and an expiration date.
How does the DSCSA saleable returns requirement work?
A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products. The manufacturer must provide a verification response within 24 hours. Wholesalers are called requestors and manufacturers are called responders.
The VRS and the DSCSA saleable returns verification requirement
The VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement. It’s an automated service that verifies if a PI is valid. A solution provider enables the verification requests to be routed between wholesalers and manufacturers.
Be sure to join Brian on June 15 for “The Verification Router Service: Aligning to the Standard,” the first in our rfxcel DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the saleable returns verification requirement and other key DSCSA requirements.
See you on June 15!