LSPediA is issuing a critical and timely letter to wholesale distributors to call attention to the need to keep good products in play. Wholesalers should take action today by requesting a Verification Readiness Assessment.
The upcoming DSCSA compliance mandate targeting November 2019 for salable returns verification presents significant regulatory challenges and business risks to wholesale distributors. In 2020, a similar compliance mandate takes effect for dispensers and healthcare providers.
On average, 2%of products are returned by dispensers to wholesalers. Is your revenue and business process at risk? Furthermore, can you meet your customers’ 2020 verification requirement?
The verification requirement is a milestone for the U.S. Rx supply chain in that serialized barcodes and associated data will be used as more than just new artwork on packages. They will be utilized to identify a product’s authenticity via the verification process.
The current wholesale distributor process for salable returns verification is far from broken. In fact, the diligent efforts of wholesalers keeps the supply chain at optimal efficiency by restocking the 2% saleable returns, ensuring product availability for patients.
The DSCSA specifically targets the salable returns process because of its potential to allow suspect and illegitimate products to breach the secure supply chain. The verification process is intended to enhance the inspection process by utilizing the unique product identifiers embedded in the serialized 2D barcodes.
However, the serialized barcodes now in the U.S. Rx supply chain have shown a less than stellar ability to be properly scanned. Currently, three out of ten 2D barcodes fail because of data parsing, expiry date anomalies, and other reasons. Using a conventional VRS solution without workflows to manage those faulty barcodes will likely cause good product to be removed from the supply chain simply due an inability to resolve the exceptions in a timely fashion. The loss of these products will have a ripple effect of supply chain disruption, including lost sales, back orders, and lead to the need for manufacturers to increase production to fill the void.
Conventional Solutions Fall Short
All currently available VRS solutions (save one) lack the ability to manage faulty barcodes. This becomes glaringly problematic due to their fundamental design flaw of providing only binary “yes/no” verification. All negative verifications are simply categorized as negative, leaving wholesalers unable to resell them.
This creates the necessity to investigate and manage exceptions to salvage good products with faulty barcodes. The DSCSA allows 24 hours to resolve questionable scans. The likely loss of products is inevitable as distributors simply don’t have the capability via conventional solutions, or the warehouse footprint, to hold products past 24 hours as the next batch of salable returns arrive.
The arbitrary, but necessary, disposal of these products for simple “negative verification” identification takes in one more critical twist with severe compliance implications – suspect or potentially illegitimate products are babies thrown away with the bath water. Requirements to properly identify, quarantine, investigate, and report suspect products are being enforced by the FDA today. Enhanced systems and processes are essential to capture and manage unverified suspect products with this upcoming compliance mandate, and conventional VRS solutions aren’t enough. They only offer the false sense of an enhanced process while actually creating a critical regulatory risk for both wholesalers and manufacturers.
Only one solution provider has addressed the nuance of what constitutes a negative verification to enable a timely and pragmatic approach to the exception management process – LSPediA’s OneScan® VRS with Investigator®. This solution categorically identifies negative verifications and alerts the corresponding manufacturer in real time, allowing the manufacturer to enable verification by resolving the faulty barcode issue or confirming a need to quarantine suspect products. The alternative produced with conventional VRS solutions requires wholesalers to conduct this anomaly identification manually. However, hiring large support organizations or offering self-service doesn’t provide pragmatic relief to the monumental task, nor are the approaches scalable or business savvy in terms of resource cost vs. solution cost – where the solution truly meets the needs of the challenge-at-hand.
LSPediA offers a free evaluation to assess your readiness and risk. Following the assessment, we’ll provide you a free report with the data we collected:
- Percentage of inventory in your warehouse with faulty barcodes;
- Revenue exposure of saleable returns;
- Regulatory risk towards solution gaps of suspect product management;
- Readiness for your customers’ upcoming 2020 deadline.
Keep good products in play and identify and investigate those bad products that are the true targets of the DSCSA regulations. To mitigate your risk, take action today:
The right solution should provide business value and risk mitigation your compliance process – not compromise it. We welcome taking the next steps to share the value proposition with you and your Quality, Regulatory, and Channel Management stakeholders.
About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain® and OneScan® Verification Router Service protect pharma companies against regulatory risks and improve supply chain efficiency. Pharmaceutical manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to manage serial data, distribute serialized drug products, verify the validity of the drug product.