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US DSCSA – Saleable Returns Verification

According to the Healthcare Distribution Alliance (HDA) which represent wholesale distributors in the U.S., every year, approximately 60 million units of pharmaceutical saleable product are returned annually as a result of overstocked or overorder of products. Returns are a complex and crucial stage in the product lifecycle. Product returns which are classified into saleable and non-saleable must be handled with swiftness and efficiency.

The Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification will regulate, verify product authenticity and enable returned saleable product to the market. This new requirement will not only maximize the potential revenue of saleable returns but will avert drug shortages, and at the same time identify and prevent non-saleable returns such as expired, damaged, or recalled products being reintroduced into the supply chain.

Saleable Return Verification will debunk the underlying assumption that saleable returns verification is just a wholesale distributors problem because it will impact manufacturers and their involvement is vital. This is a time-sensitive verification process, and DSCSA will allow manufacturers one working day (not exceeding 48 hours) to reply. Wholesale distributors will be required to verify serialized product identifiers upon receipt of a returned product before they can quickly return them to the supply chain.

To support this requirement, it must be a two-way street between manufacturers and wholesalers in finding effective solutions to cope with saleable returns (worth billions), prompt communication and exchange of product master data and real-time response to verify and facilitate the salability of products without delay and disruption.

It’s been speculated that at the request of the Healthcare Distribution Alliance (HDA) the US FDA may announce a delay in enforcement action for the DSCSA’s November 2019 deadline for saleable returns verification requirement. According to latest reports, the deadline for saleable returns verification has been pushed ahead to November 27, 2020. While, the deadline for non-saleable returns and recalls will be effective as planned, which is November 27, 2019.

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