FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2).
FDA is concerned that large volume of saleable returns coupled with the challenges of establishing reliable and robust technology may disrupt the distribution of prescription drugs in the United States.
FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product. This is a 3-year delay from the current date of enforcement.
FDA also does not intend to take action against dispensers who do not verify the product identifiers of suspect product as required by DSCSA before November 27, 2023.
Instead the FDA believes that the delay in enforcement will allow manufacturers, repackagers, wholesale distributors and dispensers to focus resources and efforts on implementing secure, interoperable, electronic tracing of products at the package level.
“We envision that, along with other enhanced drug distribution security requirements, wholesale distributors can increase their efficiency by incorporating the saleable return verification requirements into the enhanced verification required by 2023 instead of developing separate processes or infrastructures.”
This delay does not affect other aspects of DSCSA. Manufacturers are still obligated to conduct product verification according to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from an authorized wholesale distributor. Furthermore, a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier.
Please contact us if you have additional questions on this policy and the impact on DSCSA deliverables.