Drug Pedigree Standard Established

By Bill Swichtenberg, Senior Editor A collaborative way to exchange document-based pedigrees for pharmaceuticals and other industries has been ratified. GS1 EPCglobal, the not-for-profit standards organization dedicated to driving global adoption of the Electronic Product Code (EPC) for supply chains, has announced the approval of the EPCglobal Electronic Pedigree Document specification. A drug pedigree is a record of each distribution of a prescription drug from its sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other authorized person administering or dispensing the prescription drug. Drug pedigrees are designed to protect patients from the potential harm of counterfeit drugs. The new open standard was developed to help companies that are serializing products using EPC technology to comply with pedigree regulations. The initial focus of the standard was compliance with the Florida Drug Pedigree Act (which went into effect in July 2006), but it was designed to allow for multiple interpretations of the existing and possible future U.S. state, U.S. federal and international pedigree laws. A version mechanism is included to allow for changes that may be necessary as the result of future laws. “This effort marks an important step in ensuring trading partners have an interoperable way to exchange document-based pedigrees for pharmaceuticals and other products,” says Chris Adcock, president of EPCglobal Inc. The standard includes an ePedigree (electronic pedigree) document schema as well as an ePedigree envelope schema that companies can use as a way of holding multiple ePedigrees together in a single document for electronic transmission. The use of the pedigree schema does not guarantee compliance with the laws. However, EPCglobal believes that all of the necessary ingredients are present to enable the users to comply with these laws. The need for a standard electronic document format that can be