There’s a lot of chatter going on now about the November drug verification deadline, including what works, what doesn’t work, and how the FDA and pharma industry will cope. Let’s review.
The 2013 Drug Supply Chain Security Act aims to combat the threat of pharmaceutical diversion by enhancing the traceability of prescription drugs in the United States. One milestone in the progress towards the 2023 deadline for full product traceability begins Nov. 27. Starting on that date, each wholesale distributor is required to trade serialized products only and to verify the product identifier on any returned unit the distributor plans to resell.
A survey conducted by the Healthcare Distribution Alliance found that 2% to 3% of total sales consistently come back as saleable returns, totaling nearly 60 million units a year. Given the large volume of returns, the traditional method of verification – individually calling or emailing manufacturers – simply is out of the question.
To efficiently and safely handle this nearly $11 billion flow in salable returns, the VRS solution has emerged as the leading technology meeting the DSCSA’s 2019 requirements.
LSPediA Enables Sub-second Serial Verification
VRS handles verification by authenticating a product identifier (GTIN, Serial, Lot, Expiry) with the corresponding manufacturer’s EPCIS data repository. The VRS concept was initiated by the HDA’s VRS Task Force, consisting of industry stakeholders and solution providers.
LSPediA worked closely with the HDA and the leading wholesalers through the HDA VRS pilot projects in the development of our VRS offering. Our robust, dependable verification technology isn’t only on the market right now, saving clients time and money.
This is an especially important moment for wholesale drug distributors and manufacturers, who have just a few months to prepare for the FDA’s November saleable returns verification deadline. Under the DSCSA, wholesalers must demonstrate that they are verifying each product identifier on all restocked returns. Our technology returns the 60 million units to stock with one automated scan in a smooth and orderly fashion.
Largest Industry Coverage
The development of a wider ecosystem and the adoption of advanced technologies are important factors in establishing the interoperable electronic tracking system due in 2023. To that end, the success of the VRS network hinges on wide participation from manufacturers and wholesalers.
In production since November 2018, LSPediA’s VRS has given our customers access to nearly 10,000 GTINs and conducted nearly 100,000 live verifications, providing 100% accurate sub-second response times. We continue to work with our wholesaler customers, on-boarding their manufacturer suppliers, uploading the manufacturer GTINs to the lookup directory, and setting connection endpoints that enable interoperable GS1 standard VRS verification messages.
With barely five months left, LSPediA encourages you to contact us to get ready for the November compliance requirement. Your timeline ought to include the VRS implementation as well as the time required to update the company policies, SOPs, and work instructions. In addition, employee training and trading partner communications are required to make the November transition a smooth one without interruptions.
About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain®, RxChain® Mobile, and our 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.