FDA holds workshop on drug track and trace program

April 30, 2014

FDA is holding a public workshop on its proposed prescription drug tracking system on May 8-9.

FDA is holding a public workshop on its proposed prescription drug tracking system on May 8-9.

The workshop, “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” will be held at the FDA White Oak Campus in Silver Spring, Md. At the meeting, interested stakeholders can give their input on the development of initial standards for the interoperable exchange of information between trading partners.

FDA has been advancing its efforts to implement a drug tracking and tracing program since the Drug Supply Chain Security Act (DSCSA) was signed into law last November. “We are working now to develop standards for this new system and we can’t do it alone. Stakeholders – including drug manufacturers, wholesaler distributors, repackers, and many dispensers (mainly retail and hospital pharmacies) – will be working with us,” Ilisa Bernstein, PharmD, JD, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, wrote in a recent FDA Voice blog post.

“The system, which will include a history of the transactions involving each drug product, will also help to enable more efficient recalls to remove drugs from the market that are considered potentially dangerous,” Bernstein added.

The ultimate goal of the track and trace system is to identify individual prescription drug packages in a way that will enable rapid and accurate verification of the legitimacy of a product, according to Bernstein. “If a counterfeit or other harmful drug is discovered in the supply chain, we can immediately notify patients, health care professionals, hospitals and others about the public health risk,” she wrote.

The public workshop, as well as other input from all stakeholders, is urgently needed, according to Bernstein, because the DSCSA requires FDA to issue a draft guidance document with initial standards by November 27, 2014. Then, many stakeholders must establish systems and processes that will enable them to comply with the law by January 1, 2015.