Pharmacy Track-and-Trace Compliance Deadline Again Delayed by FDA


The FDA has once again delayed its enforcement of product tracing requirements for pharmacies.

The FDA has once again delayed its enforcement of product tracing requirements for pharmacies under the Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA).

Although these track-and-trace requirements took effect on July 1, 2015, the FDA said it would not enforce the product tracing obligations for pharmacies until November 1, 2015, which it has now extended to March.

The FDA granted this latest extension because “some dispensers—primarily smaller, independent pharmacies and health systems—have expressed that they need additional time,” the agency explained.

Many pharmacy organizations previously called for the FDA to delay implementation in order to allow pharmacies to prepare for product tracing requirements.

Back in June, the American Society of Health-System Pharmacists (ASHP) suggested that a January 1, 2016, deadline would give drug dispensers enough time to implement new systems. Now, the FDA has gone even further in delaying enforcement of the requirements 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,” Kasey K. Thompson, PharmD, MS, MBA, ASHP vice president for policy, planning, and communications, said today in a statement. “We will continue to work with FDA to ensure that ASHP members have the necessary tools and resources to comply with this important regulation.”

The updated DSCSA compliance policy recognizes that many pharmacies are working toward using electronic systems to keep track of product tracing information, such as transaction history, but may need more time to work with trading partners to ensure that they can capture and maintain these data.

In the meantime, pharmacies that do not capture and maintain product tracing information, or accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized.

However, this compliance policy does not extend to other requirements for dispensers under the DSCSA, which include verification related to suspect and illegitimate product (including quarantine, investigation, notification, and recordkeeping) and engaging in transactions only with authorized trading partners.

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