Farmington Hills, Michigan, April 30, 2019 – LSPediA Inc., a leading software and service provider for the pharmaceutical industry, today announced the addition of notification for recalled and suspect product investigation to its Verifier® Verification Router Service.
“While suspect and recalled drugs are just a small portion of returned products, failing to identify those drugs and document their handling can be a serious liability for a distributor and a danger to the general public,” said LSPediA CEO Riya Cao. “The FDA is taking that part of the DSCSA rules very seriously.”
The added functionality of LSPediA’s Notifier® element manages inbound and outbound notifications for recalled products, suspect products, and investigations. Notifier® also provides automated workflow to initiate quarantines, conduct verification, file FDA 3911 reports, and notify trading partners, as required under the Drug Supply Chain Security Act. All events are captured with a complete history for six years and are easily accessible for audits.
Clock is ticking down on notifications
The notification requirements of the DSCSA for wholesale distributors requires that they verify all potentially saleable returned drugs, but that they also notify the FDA and trading partners when they find suspect or illegitimate products. While the bulk of saleable returns – about $11 billion in product each year – consists of legitimate, saleable drugs about 2 percent – or nearly 12 million units per year – are suspect or outright fraudulent. That deadline is fast approaching: Nov. 27, 2019.
Without a rock-solid workflow built into the verification process, distributors face the prospect of being forced to manually check and confirm their share of those 12 million units, a process that is sure to be expensive, time-consuming and confusing – all while being exposed to FDA fines and liability if anything is mishandled.
LSPediA’s Verifier® is already up and running, a stand-alone, turnkey VRS solution that has conducted nearly 50,000 successful scans in the three short months since its release. VRS already has emerged as the preferred platform for verifying returns among trading partner globally and in the U.S., with an eye toward maximizing revenue in the $11 billion market for saleable returns. In addition, LSPediA’s Notifier® add-on to provides an automatic workflow for your company to handle questionable returns, including automated 3911 reporting.
For more information or a demonstration of LSPediA’s Verifier® Verification Router Service with Notifier®, sign up for our weekly newsletter or email email@example.com.
About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPediA’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting.