Verification Router Service

FDA Announces Enforcement Delay for Verification of Saleable Returns

Verification Router Service

The next major milestone of the Drug Supply Chain Security Act (DSCSA) is rapidly approaching and goes into effect on November 27, 2019. Verification Router Service has been at the forefront for pharmaceutical suppliers and manufactures to meet the DSCSA requirements for wholesale distributors to verify returned products with the product’s manufacturer before returning those products back into distribution.

Recently, the FDA announced a delay in the verification’s enforcement requirement for Salable Returns until November 27, 2020, in an updated Wholesale Distributor Verification Requirement for Saleable Returned Drug Product guidance document. The FDA cited significant concerns raised about “industry-wide readiness for implementation” and “complexities of building an interoperable, electronic system with the capabilities to timely and efficiently verify the large volume of saleable returned products amid immature technologies.”

It should be noted that this one-year enforcement delay is only applicable to the verification requirements of section 582 (c)(4)(D) for Salable Returned Products. All other November 2019 requirements for wholesalers and manufacturers are still required and will be enforced.

Specifically, the FDA noted to manufacturers that this enforcement delay “does not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor.”

Axway’s VRS (Verification Router Service) Solution

While this delay offers a slight reprieve, wholesalers and manufacturers must continue to work diligently at establishing a strong and interoperable system to meet all the DSCSA requirements.

Axway is pleased to offer a solution! The Axway VRS Solution is powered by Axway’s market-leading Amplify API Management solution and Axway Decision Insight, a recognized leader of real-time analytics and data intelligence solutions. You can be assured this is a tried and tested solution that is secure, interoperable, and easily scalable and will give you full compliance today and for the future.  Our proven technology enables the support of multiple protocols and data formats and provides flexible security and user control polices and much more and all with no need for your existing solutions.

Download our guide to meet the interoperability challenges of DSCSA compliance.

Key Takeaways

  • The Drug Supply Chain Security Act (DSCSA) is rapidly approaching its next major milestone, with enforcement requirements set for November 27, 2019.
  • The FDA recently announced a delay of the verification requirement for Salable Returns until November 27, 2020 due to industry-wide readiness and complexities in building an interoperable system.
  • While this offers some reprieve from the DSCSA requirements, manufacturers must still meet all other obligations by the required date.
  • Axway’s VRS Solution is powered by Amplify API Management and Decision Insight solutions; it provides secure interoperability and scalability needed to comply with DSCSA regulations today and into the future.