The US FDA published a compliance policy guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product. Despite this discretion, wholesalers and manufacturers need to keep driving forward. Read our article “FDA Enforces Five Verification Requirements for Manufacturers” – published on 10/15/2019 – for an in-depth look at the multiple requirements that will still be enforced starting November 27, 2019.
LSPediA’s clients plan to stay the course with the original DSCSA timeline and be compliant by the original enforcement date regardless of the discretion. Watch the video above to learn how hitting the original enforcement date is benefiting companies such as Drogueria Betances and others, as well as gain insight from our industry-leading partners at Axway.
Use the discretion period to be thoughtful, innovative, and prepared – not to rest in a manner that finds industry in the same precarious state of unreadiness next year. Your goals should be to work smarter, reduce waste, and generate profitability; and to choose solution partners that share the same vision. Reach out to us today.