Drug Pedigree Standard Established

By Bill Swichtenberg, Senior Editor

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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.

EPCglobal logoThe 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 updated by each supply-chain participant was the impetus for the creation of this document. However, there is recognition that not all members of the pharmaceutical supply chain will adopt the XML Schema that is specified in this standard. Therefore, the schema includes elements that allow the attachment of other document types as MIME documents.

The standard does not identify exactly how pedigree documents must be transferred between trading partners. Any mechanism chosen must provide document immutability, non-repudiation and must be secure and authenticated. The new standard is designed to enable technology providers to create solutions that can provide interoperability across the supply chain, from manufacturers to wholesalers to retailers. The full standard is at www.epcglobalinc.org/standards/#DPS.

A recent injunction granted by a U.S. federal court may have an impact on pedigrees. The ruling delays requirements in the Prescription Drug Marketing Act (PDMA) of 1987 regarding pedigree requirements that would have gone into effect on Dec. 1, 2006. Six wholesalers brought the lawsuit against the FDA and the Department of Health and Human Services because it would have required distributors who are not "authorized distributors of record" to produce pedigrees, but exempted the authorized distributors from the same requirement.

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