1 September 2006

Tracking and Traceability: It's the Law

The U.S. Bioterrorism Act of 2002, in direct response to the terrorist attacks of 11 September 2001, requires manufacturers in the U.S. to establish and maintain records of where they purchased an item and who they sold it to. There's also a tracing requirement about when they receive it and where it goes. The Food Allergen Labeling Consumer Protection Act requires labeling of major food allergens. The Food and Drug Administration (FDA) standard CFR21 Part 11 requires electronic signatures when changes occur in the manufacturing process.

Now the FDA is taking a more proactive stand for people to use radio frequency identification (RFID) technology, said Jerry Horne, solutions key account manager at MARKEM. Part of the FDA law enacted back in the 1980s required a pedigree to track manufacturing all the way to consumption. But because of a rise in counterfeiting paper documents, the FDA now recommends using electronic documents and tracing with RFID technology.

The FDA will "fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products," or pedigree, "throughout the distribution system," officials said in a 9 June 2006 FDA press release. In the same release, the FDA announced new steps to protect consumers from counterfeit drugs; using electronic track and trace technology, such as RFID, which creates an electronic pedigree (e-pedigree) for tracking the movement of the drug through the supply chain.

During the next year, the FDA's enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion. By educating consumers about RFID and the labeling of RFID-tagged drug products, the FDA hopes to further the effectiveness of current food and drug safety laws.

About the author

Ellen Fussell Policastro is the assistant editor of InTech. Her e-mail is efussellpolicastro@isa.org.