The FDA guidance letter is a delay in enforcement with the expectation pharmacies continue to progress toward DSCSA implementation. The FDA would like all trading partners to...Read More »
May 19, 2019 – Over the past several years, InfiniTrak has been asked to be a part of the regulatory and compliance discussion with a variety of government and state agencies. InfiniTrak continues to be in the fore front of all aspects of Track and Trace. The company’s highly skilled tech development team has captured the attention of many of the leading regulatory agencies in both the federal and state governments. Our mission has broadened over the past decade from patient safety to the safety and well being of all Americans. What started as building the most innovative and efficient DSCSA solutions to secure this country’s drug supply chain from manufacturers, to distributors to every dispenser has expanded to track and trace of all controlled substances for law enforcement and various other monitoring and quality-controlled securitization.
Last month, several top executives from InfiniTrak met with top level directors of the Health & Human Services in Washington D.C. about utilizing our Controlled Substance Tracking System. This meeting led to working with HIDTA agencies that could benefit from our real time alerts and proprietary advanced data analytics. This coordinates with our previous week focusing on our customized solutions to direct areas of need in the United States. During a time when the Opioid Crisis has caused the third consecutive year of declining life expectancy in the United States, we are enthused that these regulatory agencies are inspired to utilize our expertise.
The FDA has delayed some of the timeline from their original DSCSA schedule. This has created a window for InfiniTrak to add expanded functionality above and beyond what is required by the Drug Supply Chain Security Act. In addition, our innovative custom solution will continually be adding new functionality aimed at improving and expanding our industry leading dynamic. Our next series of regulatory meetings will be at the end of summer 2019.