Recent FDA Announcement to delay enforcement of the “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product (VRS)!

by Banu Ozkaya

In response to the recent FDA announcement to delay enforcement of the “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product (VRS) – Compliance Policy” for one year from November 27, 2019, to November 27, 2020, Supply Chain Wizard offers the following guidance:

Decision clarification: The compliance deadline has technically not been extended. According to the FDA’s ‘‘Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy”, the compliance date remains November 27, 2019. However, the FDA will not act on non-compliant manufacturers, who fails to meet the official regulation deadline for 1 year.

The attached extract, https://www.govinfo.gov/content/pkg/FR-2019-09-24/pdf/2019-20651.pdf, says this:

“This guidance describes FDA’s intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement."

What this means for you:

Although the requirement is targeted towards wholesalers and is dependent on Wholesalers being ready to test, manufacturers face a subsequent need to align with the wholesalers ability to verify. Supply Chain Wizard advises to keep open communication with your wholesalers and downstream supply chain partners to align associated timelines.

In the broader view of Unit Level traceability requirements targeted for 2023, the requirement to provide serialization related information across the supply chain remains unchanged.

Source: https://www.federalregister.gov/documents/2019/09/24/2019-20651/wholesale-distributor-verification-requirement-for-saleable-returned-drug-product-compliance-policy

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