Comply with DSCSA Saleable Returns Verification

WHITE PAPER

Written by Carina McGlasson


Learn About the Regulation

Saleable returns verification is the next big milestone of the U.S. Drug Supply Chain Security Act (DSCSA). By November 2023, wholesale distributors must verify the serialized product identifiers of saleable products that have been returned before the products can be resold. With around 60 million pharmaceutical saleable returns in the US market every year*, solutions must be able to handle the expected high volume of saleable returns that need to be verified. Additionally, wholesale distributors need an easy-to-use and simple-to-configure scanning solution that provides real-time feedback on the product’s authenticity after each scan to minimize operational impacts.

Drug Supply Chain Security Act Timeline

Methods of Transaction History, Transaction Information and Transaction Statements

A saleable return occurs when a pharmacy returns a pharmaceutical product to a wholesale distributor. Currently, if there is evidence that the product has been handled properly and is not damaged or expired, it can be resold. With the upcoming deadline, wholesale distributors are required to verify the product identifier, including the GTIN, serial number, lot number and expiration date, on each package or on each sealed homogenous case of saleable return products. "Verification” or “verify” means determining whether the product identifier affixed to, or imprinted upon on a package or homogeneous case corresponds to the product identifier assigned to the product by the manufacturer or the repackager. Only if the authenticity of the returned product is proven, it can be resold again. This means that wholesale distributors need a scanning and verification solution that streamlines the bi-directional data flow between manufacturers and wholesale distributors and provides real-time feedback. Currently, many wholesale distributors rely on point-to-point solutions or even on manual processes to verifiy their saleable return products. Furthermore, manufacturers must reply to verification requests only within one business day according to the DSCSA. This lack of real-time feedback significantly impacts the efficiency of wholesale distributors’ warehouse and business processes.

The Out-Of-Box Scanning and Verification Solution

The cornerstone's of Movilitas.Cloud’s out-of-box scanning and verification solution are the Verification Routing Service (VRS) and the Lookup Directory (LD). VRS allows wholesale distributors to verify pharmaceutical products by scanning the product identifiers and passing the information to the VRS. Consulting its internal lookup directory, the VRS identifies where to route the verification request, it identifies the manufacturer of the product. Next, the verification request is automatically sent to the VRS of the product manufacturer and the product identifiers are verified against manufacturer’s product serialization data. The response is sent back to the wholesale distributor in real-time.

VRS Solution for DSCSA Compliance

With Movilitas.Cloud’s VRS solution you can comply with DSCSA Saleable Returns Verification requirements within an hour and handle your verification requests in real-time.

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