FDA delays enforcement of Track and Trace requirements
The requirements were supposed to go into affect today.
The policy change came after the ASHP, which represents pharmacists serving patients in acute and ambulatory settings, asked the FDA to give hospitals and health systems more time to comply with the regulations.
In a letter to the FDA, ASHP described substantial compliance challenges with the requirements, including the time needed by institutions to implement, test and operationalize data collection and storage processes.
“We are extremely pleased with FDA’s extension of the July 1, 2015, deadline,” ASHP CEO Paul W. Abramowitz said. “The leadership at the FDA was very engaging and understanding of the patient care challenges that the July deadline posed for ASHP members and others in the supply chain. We look forward to continuing to work with the FDA to implement this important regulation, and to providing the tools and resources ASHP members need.”
The Track and Trace requirements are part of the Drug Quality and Security Act, which requires prescription drug data to be tracked through the supply chain.