White Paper: Implementing The ePedigree Plan: Serialized Distribution Operations For ePedigree Compliance

By ACSIS, Inc.

Pharmaceutical pedigree requirements have been in flux for many years, as state governments, federal agencies and the industry battle over the most secure and efficient method to reduce counterfeiting and diversion by tracking the movement of drug product along the supply chain.

Today, the confusing patchwork of governing laws requires that manufacturers, wholesalers and distributors provide, at a minimum, a paper-based record of the quantity, manufacturing lot number and purchase order number of a particular drug. But this process leaves the documents open to human influence, such as error and falsification. The industry and government understand that pedigree information needs to be electronically recorded to better secure patient safety—yet they haven't agreed on the best way to make it happen.