FDA lifts delay on enforcing drug pedigree rules

09.06.2006
The U.S. Food and Drug Administration (FDA) announced Friday that it will begin enforcing regulations next year that require pharmaceutical companies to document the chain of custody for drug products to protect them from counterfeiting.

The FDA will begin to enforce all regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation on the chain of custody -- or pedigree -- of drugs. In early 2004, the FDA delayed provisions of the legislation requiring pedigrees to allow the industry time to adopt electronic technology such as RFID tags for tracking drugs. However, the FDA had expected electronic pedigrees to be widely used by 2007 to protect drugs from tampering or counterfeiting, it said in a statement.

Because of a lack of widespread adoption, the FDA will lift the hold on the rules -- which is set to expire in December.

During the next year, the the agency said it will focus its enforcement of the pedigree regulations on products most susceptible to counterfeiting. In addition, FDA officials will be issuing guidelines on its enforcement approach.