Is everybody ready to handle the DSCSA Verification Requirements going into effect next week? Despite the FDA enforcement delay on the requirement to verify saleable returned product, wholesale distributors are still responsible to deliver against sections 582 (c)(4)(A), 582 (c)(4)(B), and 582 (c)(4)(C). The four sections and their enforcement status are summarized in the table below.
Table 1 DSCSA Verification Requirement
|582 (c)(4)(A)||Wholesale Distributor Requirement for Verification of Suspect Product||No Delay||11/27/2019|
|582 (c)(4)(B)||Wholesale Distributor Requirement for Verification of Illegitimate Product||No Delay||11/27/2019|
|582 (c)(4)(C)||Wholesale Distributor Requirement for Verification Electronic Database||No Delay||11/27/2019|
|582 (c)(4)(D)||Wholesale Distributor Requirement for Verification of Saleable Returned Product||Delayed||11/27/2020|
As this relentless countdown timer shows, that leaves you with only a few days and hours to get your verification solutions in place. Implementations for VRS are at full tilt with the FDA sharing an intent to begin site visits to ensure readiness. The LSPediA OneScan solution suite, including the Verifier and Investigator module, enables both audit trails and a dynamic approach to ensure confidence against regulatory risk for negative verification related suspect product investigations as well as cargo theft. Contact us before this clock runs down to ensure compliance confidence against these critical mandates.
About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solutions RxChain®, RxChain® Mobile, and OneScan® VRS protect pharma companies against regulatory risks and improve supply chain efficiency. Pharmaceutical manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to manage serial data, distribute serialized drug products, and verify the validity of the drug products.