FDA Agrees to Additional Extension of Track and Trace Enforcement Deadline

PRESS RELEASE

Bethesda, MD - The Food and Drug Administration (FDA) announced today that it will again delay enforcement of Track and Trace requirements that were scheduled to go into effect on November 1, 2015, until March 1, 2016.

ASHP last week met with representatives from the FDA to discuss ongoing concerns with implementation, including some unresolved questions about certain types of exceptions from the Drug Quality and Security Act (DSCSA) requirements. In June, ASHP sent a letter to agency officials describing the significant challenges to compliance with the requirements, including the time needed by institutions to implement, test, and operationalize 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,” said Kasey K. Thompson, Pharm.D., M.S., M.B.A., ASHP Vice President for Policy, Planning and Communications. “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

that prescription drug data be tracked through the supply chain, from the manufacturer or end user, or dispenser. Under the rules, hospitals and health systems must collect and store information provided by manufacturers that identifies drug products to the lot level. The requirements were originally scheduled to take effect on July 1, 2015.