California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop

Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus.

Citing the heparin investigation in particular, Herold reported on the work California has done to understand the weaknesses in the current Rx distribution and recall system, and stressed the importance of finding ways of addressing them.  California has been on the forefront in its efforts to push forward with implementing an effective track and trace system to address its concerns.

[Editor’s Note:  FDA has also continued to investigate the events surrounding the 2008 heparin contamination.  A recent warning letter issued to heparin API supplier Scientific Protein Labs stemming from the agency’s investigation sheds light on concerns related to how recalls are being managed at the manufacturer level (IPQ “In the News” Feb. 6)].

FDA held the public forum to draw input from the participants across the supply chain on how an effective track and trace system could be developed.

The intention of the workshop, the agency explained, was to address “the attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages” and help further the goal of securing the drug supply chain against the introduction of counterfeit and other substandard drugs.

Following opening presentations by agency officials and California’s Herold, breakout sessions were held to discuss three key areas instrumental to a track and trace system:  ● interoperability (data sharing between the subsystems involved) ● product authentication, and ● data management (format, storage, capture and protection of data).

The workshop concluded with summaries and discussions of the inputs received.

[The compelling results of California’s investigation into the heparin recall and how the shortcomings in the current recall/distribution system support the need for a track and trace approach are explored for subscribers hereNon-subscribers can purchase the full story for $95 by contacting Karen Bertani ( For subscription information click here.]