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As many in the industry may be aware, the Drug Supply Chain Security Act (DSCSA) has seen its share of developments since its inception back in November of 2013. Keeping this in mind, education has been essential in being able to accurately keep pharma stakeholders abreast on the latest, so Pharma Commerce has taken pride in being a resource for that.
Below are the various DSCSA resources that our readers have found value in, listed in no particular order—one may also notice that most of these are recent, due to the various developments that occurred over a short burst of time.
Navigating DSCSA Delays
In a video interview with Pharma Commerce, Joe Lipari, direct of product management for Systech, dives into how the DSCSA, signed into law by President Obama in 2013, has actually been in development for nearly two decades, with earlier state-level efforts like California’s e-Pedigree push. Initially, the full implementation deadline was set for Nov. 27, 2023, marking the completion of serialization and traceability across the pharmaceutical supply chain. However, due to industry readiness issues, the FDA introduced a “stabilization period” to allow for testing and system adjustments. The stabilization period, meant to iron out bugs, turned into a series of delays, and the implementation date has been pushed back multiple times.
Watch the video.
Nov. 27 is Here: What Does That Mean for DSCSA?
In this episode of The PC Podcast, Nicholas Saraceno, Pharma Commerce’s editor, explains the history behind the DSCSA; the significance of Nov. 27; the latest DSCSA exemptions and what that means for trading partners; how this piece of legislation and AI are able to intertwine
Listen to the full episode.
Did Industry Fumble the DSCSA Deadline?
Like a football game where the ball is fumbled at the goal line, the US pharmaceutical supply chain must wait yet again for a complete traceability solution to take effect. When the Drug Supply Chain Security Act (DSCSA) was passed in 2013, it set a 10-year process of industry preparation for tracking pharmaceuticals at the package level, from point of manufacture to point of dispensing. In 2023, the FDA allowed for a one-year “stabilization period” before enforcing the law. Now, a year later, it has again deferred enforcement, depending on the type of trading partner, for six months to two years.
Read the full article.
Understanding the FDA’s Exemption for DSCSA Compliance
On Oct. 9, 2024—49 days before the end of the one-year stabilization period under DSCSA—the FDA issued an exemption for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements. The exemption duration varies by partner type and is intended for partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges exchanging data, helping to prevent delays in medication delivery.
Read the full article.