Newswise — The Food and Drug Administration (FDA) announced today that it will delay enforcement of Track and Trace requirements that were scheduled to go into effect on July 1, 2015, until November 1, 2015. This policy change follows a formal written request by ASHP urging FDA to give hospitals and health systems more time to comply with the regulations.
In a letter sent on June 16, ASHP described significant challenges to compliance 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, said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D., (Hon.). “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.”
Title II of the Drug Quality and Security Act (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.
More details are expected regarding dispenser tracing requirements under the DQSA following a conference call with FDA scheduled for July 1.
About ASHPASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s more than 40,000 members include pharmacists, student pharmacists and pharmacy technicians. For over 70 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, www.ashp.org, or its consumer website, www.SafeMedication.com.
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