FDA details guidance for drug pedigree due date

The Food and Drug Administration today provided guidance for its policy effective Dec. 1 that prescription-drug wholesale distributors should meet to document the authenticity of their products through the supply chain to the retail pharmacy or hospital provider. The documentation acts as a pedigree to protect consumers and industry against drug counterfeiting.

A pedigree, a provision of the Prescription Drug Marketing Act, enacted in 1988, creates a statement of origin that identifies each prior transaction of the drug, including names and addresses of all parties.

The FDA, an agency of the Health and Human Services Department, has delayed the provision for supply chain documentation for several years in hopes that the pharmaceutical industry would widely adopt electronic track and trace technologies, such as RFID. Distributors are just beginning to develop electronic records, so FDA has lifted the compliance policy delay, FDA said in its posting. The policy requires paper or electronic tracking and tracing of a drug product.

Although FDA has stated that RFID is the most promising means to achieve an electronic pedigree, bar codes and other track and trace technologies can also produce it.

FDA's guidance describes how the agency plans to prioritize enforcement during the first year through Dec. 1, 2007, based on the types of drugs that are of the greatest concern'those that are most susceptible to counterfeiting or diversion. The guidance reflects a phased-in approach so drug distributors know where to focus their initial energies to comply, FDA said.

The guidance is not binding, but FDA may begin regulatory action, including criminal prosecution, for violations of the pedigree requirements, FDA said. FDA also provided an accompanying document of questions and answers for industry.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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