- Global Pharma News & Resources

Are you using the guidelines for drug saleable returns optimally? Here are the critical success factors (CSFs) to tell you whether you are doing it the right way

Are you using the guidelines for drug saleable returns optimally? Here are the critical success factors (CSFs) to tell you whether you are doing it the right way


Do you know everything about return saleables? Do you know how to use it as a stepping stone to achieve DSCSA compliance? What are the critical success factors determining the success of verified return saleables? The article talks in details about the warehouse equipment required for VRS, the right tools required for verification, and the storage requirements during the VRS process.
Editor: Kaustav Sarkar Last Updated: 13-Nov-2020

The VRS-compliance deadline may have been pushed by 3 years, but following the journey to complete compliance, be it VRS or others, continues. The drug supply chain stakeholders were on their toes to get the right equipment to ensure that a delay in compliance does not come in their supply chain management. Now, they can relax and take their time for compliance. However, the need of supervision still remains. This is because close to 93% of the drug returned to wholesalers after pharma serialization is still saleable that can make the drug supply chain richer by $7billion to $8billion.

For those who have already started their compliance process, it is important to mention that the critical success factors (CSFs) that govern the VRS-compliance process, which in turn is a small part of the bigger picture of pharmaceutical track and trace, have to be met to be considered fully compliant.

Discussing the Critical Success Factors

Ideally, any warehouse handling a saleable return should follow the protocol as mentioned:

  • Stocking of temperature-controlled products upon return
  • The warehouse must ensure that the packaging is as per DSCSA requirement standards and that they are specialized return containers, comprising the right labeling and packaging.
  • It should also check if the consignment has been sent with alternative transportation mode, ideally a small package carrier than a delivery truck.

For VRS compliance, there would be many criterions requiring inspection. For instance:

Are you using the right warehouse equipment for the segregation process? The most advanced technology that are being used these days include AR-VR driven multiscanners that screen the manufacturing and compositional details of a returned consignment. The data collected is re-directed to the manufacturers for product verification. The process has to be seamless, hassle-free and fast, which ensures that the time lapse for FDA intimation after receiving the saleable returns is less than 24 hours. The usage of traceability suites cannot be discounted here, because they help in tracking the stage in which the ‘suspected’ drug is in- verification, quarantine or destruction stage.

Do you have a dedicated area for storing the returns? It is important that the saleable returns are stored away from the regular consignments; Because a small mistake can send the knock the right medicines out and send back the wrong ones.

Are you using the right tools for DSCSA serialization verification? As already discussed, right tools can go a long way in making VRS compliance hassle free. The return products need to be reconciled with the Return Authorization (RA) and physically inspected to check if they can be restocked or resold. The interference of advanced technology like multiscanners is a must here because they speed up the process of VRS verification by 6X. These equipment can handle volumes of consignments with the help of rapid screening technology, reading the GS1 code and verifying whether the ‘suspicious’ products are fake or not. Physical inspection can only ascertain if the product was damaged in transit, but cannot verify if the drug is original or not.

Are you using the right return logistics portal to update saleable returns? Many dispensers, once they have come across ‘suspected’ consignments make a list of products being returned using an online system portal developed and provided by the Wholesale Distributor’s Reverse Logistics Provider (WRLP). Data sharing is an important aspect of VRS compliance and having a centralized database, storing important information can help not a single entity of the drug supply chain but all the entities involved in it to be able to communicate with one another.  These centralized data repositories should be communicated with a uniformed form structure