FDA again delays track and trace

October 30, 2015

After meeting with representatives from the American Society of Health-System Pharmacists (ASHP), the FDA recently agreed to delay enforcement of its track and trace requirements.

After meeting with representatives from the American Society of Health-System Pharmacists (ASHP), the FDA recently agreed to delay enforcement of its track and trace requirements.

Title II of the Drug Quality and Security Act (DQSA) requires prescription drug data be tracked through the supply chain. Hospitals and health systems must collect and store information provided by manufacturers, identifying drug products to the lot level.

While the requirements were originally scheduled to go into effect on July 1, 2015, the FDA delayed track and trace until November 1, 2015. Now, the FDA has extended the deadline until March 1, 2016.

“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, PharmD, ASHP’s vice president for policy, planning and communications.

ASHP urged the FDA to delay the regulations because hospital and health systems may not have sufficient time to test or put into operation new data collection and storage systems to track prescription drug transaction data, due in part to the “uncertainty of the level of compliance among trading partners,” Thompson wrote in a June letter to FDA.

“Based upon input provided by hospital and health-system pharmacists nationwide, we believe that signficiant challenges remain for hospitals and health systems to fully comply with the new requirements by the July 1 deadline,” Thompson wrote.

 

Additionally, pharmacists have many questions on track and trace that warrant further clarification by the FDA. For example, ASHP is uncertain whether prescriptions provided to first responders such as ambulances or law enforcement will be exempt from the requirements. “A hospital supplying first responders with the opioid antagonist naloxone is generally done prior to an immediate patient need; however, it remains unclear whether medications supplied under these circumstances would fit within the exemptions,” Thompson wrote.

Another area of uncertainty is the role of dispensers and the common control exemption in cases of joint partnerships, which include hospital and health system dispensers that support rural health facilities. “Recognizing that transaction history, information and statement would need to be passed along, ASHP requests clarification from FDA on whether these dispenses would need to obtain a wholesaler license under the DQSA, or if compliance with passing the required transaction data along would meet the requirement,” Thompson wrote.