FDA Delays Track-and-Trace Enforcement Once Again

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

The DSCSA’s track-and-trace requirements took effect in July 2015, but the FDA stated it would not enforce the product tracing requirements until November 1, 2015, as the FDA felt the November extension would give drug dispensers ample time to implement the new systems.

Today, however, the FDA acknowledged that drug dispensers, primarily the smaller, independent pharmacies and health systems, still need additional time to work with their trading partners to ensure all the required data can be captured and maintained in accordance with the DSCSA.

While acknowledging the recent issues, the FDA granted another extension through March 1, 2016. During this time period, pharmacies that do not capture and maintain product tracing information will not be penalized, but will likely still be held liable for other requirements for dispensers under the DSCSA, including verification related to suspect and illegitimate products and engaging in transactions with authorized trading partners.