FDA to delay enforcement of Track and Trace requirements

Track and Trace requirements scheduled to go into effect Sunday have been delayed until March 1, according to a Thursday announcement from the Food and Drug Administration (FDA).

The American Society of Health-System Pharmacists (ASHP) met with FDA representatives last week to discuss concerns over implementation and questions about exceptions from the Drug Quality and Security Act (DQSA) requirements. ASHP also sent a letter to FDA officials explaining the significant compliance challenges faced by institutions trying to implement data collection and storage processes. 

“ASHP has remained engaged with the FDA on this challenging issue, and we are pleased with the decision to extend the deadline,” Kasey Thompson, ASHP's vice president for policy, planning and communications, said. “We will continue to work with FDA to ensure that ASHP members have the necessary tools and resources to comply with this important regulation.

Title II of the DQSA requires prescription drug data to be tracked through the supply chain from the manufacturer or end user or dispenser. Under the Track and Trace requirements, hospitals and health systems must collect and store information provided by manufactures that identifies drug products to the lot level.

ASHP represents more than 40,000 pharmacists, student pharmacists, and pharmacy technicians in acute and ambulatory settings.

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American Society of Health-System Pharmacists 7272 Wisconsin Ave Bethesda, MD - 20814