This week, the FDA announced that there will be a one-year grace period on the enforcement of the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product policy. As you know, this policy established that all US wholesalers must verify serialized products upon a request for saleable returns, per the DSCSA.
What does it mean exactly? That the FDA won’t take immediate action for non‑compliance. However, wholesalers should not see it as a “delay” per se, but rather as an opportunity to get ready as soon as possible, since legal consequences will begin on November 27, 2020.
Here’s an excerpt of the FDA’s Compliance Policy to give you some insight: “To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action before November 27, 2020, against wholesale distributors who do not verify a product identifier prior to resale or other further distribution of a package or sealed homogenous case of product as required by section 582(c)(4)(D) of the FD&C Act.”
Please read the entire FDA Compliance Policy for more information and details.
HOW OPTEL CAN HELP
Your entire compliance process, made easy! Our team is available to resolve any issues quickly and offer seamless solutions to meet the DSCSA’s saleable returns requirements. Contact us for more information!