The DSCSA dilemma: How to legitimately sell returned medicine


Sponsored by Movilitas

Every year in the United States, millions of pharmaceutical products are returned in saleable condition. Yet,

manufacturers and wholesalers must meet DSCSA regulations in order to resell these items. Complying can be a challenge unless the right solution is in place.

According to the Healthcare Distribution Alliance (HDA):

  • 2-3% of total sales come from saleable pharmaceutical returns
  • 2% of product returns are caused by overstocking medicines that are returned to wholesalers
  • $4.7 million per company is the average total annual cost of saleable returns processing

The next DSCSA requirement is for saleable returns verification. It regulates how wholesalers can legitimately sell returned medicines.

By Nov. 27, 2020, wholesale distributors must verify the serialized product identifiers of any saleable returned pharmaceuticals with the help of manufacturers. The compliance process is complex.

  • Wholesalers must verify returned products with the manufacturer before it can be resold
  • Distributors initiate a verification request to the manufacturer, who must respond within 24 hours
  • Verification ensures the product identifier is correct and true, including the serial number, lot number, expiration date and Global Trade Item Number (GTIN)

There can be lags in verification because many wholesale distributors currently rely on point-to-point solutions or manual processes. This lost time results in process disruptions and delays that can cost money and sales. A better way is a cloud solution that provides real-time feedback of product authenticity to minimize operational impacts.

Learn more from the guide How to Comply with the DSCSA Saleable Returns Verification Requirement. It covers:

  • Key aspects of the requirement
  • Impacts on wholesale distributors and manufacturers
  • How the verification router service works
  • A streamlined method for bi-directional data flow between wholesale distributors and manufacturers
  • An easy-to-use solution for verification requests


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