A pedigree is a paper or electronic document (e-pedigree) that enables a single view of the product and order and is used for drug authentication. The pedigree goes with the drug and tracks the change of custody as the drug passes through the supply chain.

The growing movement towards utilizing electronic pedigrees "ePedigrees" to track drugs in the pharmaceutical supply chain has become critical. By this date, wholesale distributions of all prescription drugs in the State of Florida must be accompanied by a complete chain of custody record. Companies found to be receiving or sending drug shipments without pedigrees may open themselves up to fines, orders to discontinue operations or event criminal investigation.

Similar pedigree requirements are expected to follow in California, Indiana, Nevada and several other states. The FDA is also considering steps to require drug pedigrees at the national level. Most companies affected by pedigree regulations will not have the option to take a wait and see approach. Now is the time to begin implementing a pedigree strategy and considering your need for a trusted solution partner.

The long-term requirements is unknown, but using Florida as an example allows us to map out what the future will probably look like.

In Florida, pedigree solutions must perform the following:

Current HDMA map:


Pedigree map