PDUFA Directs HHS to Develop Electronic Track-and-Trace Standards

Under legislation President Bush signed into law Sept. 27 reauthorizing the Prescription Drug User Fee Act (PDUFA), HHS is tasked with developing a standard numerical identifier for tracking drugs in the supply chain.

The legislation, known as the FDA Amendments Act of 2007, was passed by the House Sept. 19 and by the Senate Sept. 20. The president signed it into law just days before the Sept. 30 expiration of the previous PDUFA law.

The law gives HHS until March 2010 to develop a standard for numerical identifiers. The identifier would be applied at the point of manufacturing or repackaging, either on the pallet or package level, and should be “sufficient to facilitate the identification, validation, authentication and tracking and tracing of the prescription drug,” according to the law.

In addition, the numerical identifiers should be harmonized with international consensus standards, if practicable, the law says.

Although HHS has 30 months to develop the standard, EPCglobal — a nonprofit that promotes worldwide adoption of electronic product codes — already has ratified its electronic track-and-trace, or epedigree, standards.
 
The new law requires HHS to consider radio frequency identification technology, nanotechnology, encryption technologies and other track-and-trace authentication technologies in developing its standard for the program.

In addition to considering new technologies to track medicines, HHS must consult manufacturers, distributors and pharmacies. It also should seek input from the Departments of Justice, Homeland Security and Commerce, according to the law.