Members of the pharmaceutical supply chain have two choices when it comes to complying with the long-deferred pedigree, or
chain of custody, requirements taking effect on Dec. 1, 2006: manual or automated. Although manual data collection and maintenance
of paper records for each container's travels from manufacturer to consumer may be feasible, an automated electronic method
will provide more timely and accurate data in the long run with minimal expenditure of manpower.
As outlined in 21 CFR 203.50, the seller of a drug product must provide the purchaser with a pedigree "statement identifying each prior sale, purchase,
or trade of the drug. The identifying statement must include the proprietary and established name of the drug, its dosage,
the container size, the number of containers, lot or control numbers of the drug being distributed, the business name and
address of all parties to each prior transaction involving the drug, starting with the manufacturer, and the date of each
Electronic pedigree, or e-pedigree, systems rely on automatic identification technology to carry the serialized information
that uniquely identifies each bottle or vial. The US Food and Drug Administration favors radio-frequency identification (RFID).
The agency's Counterfeit Drug Task Force, however, noted in the June update to its report that bar-code technologies, particularly
two-dimensional bar codes, are a viable alternative and that "a hybrid approach using both paper and electronic pedigrees
will be needed during a transition period."
An e-pedigree system requires the integration of several technologies, item-level serialization, data capture at various points
in the supply chain, and recordkeeping so recipients can trace the product's trip through the supply chain and confirm its
Purdue Pharma, L.P. (Stamford, CT) quickly realized item-level tagging had track-and-trace benefits within its four walls when it started tagging
containers of its "OxyContin" pain-killer to comply with requirements of Wal-Mart Stores (Bentonville, AR).
Purdue Pharma's system consists of ultrahigh-frequency (UHF) tags and readers, device management software, and data management
software (Class 0 UHF tags and readers, Symbol Technologies, Holtsville, NY; device-management software, Northern Apex Software, Fort Wayne, IN; "Auto-ID" and "Event Manager" software from SAP AG, Walldorf, Germany). This system interacts with the company's enterprise resource-planning system ("R/3 ERP," SAP AG) and
makes it possible to link each bottle of OxyContin to a specific case and pallet.
Internally, RFID tags are read at three points: at the outfeed of the case packer, vault entry, and vault exit. The reader
at the outfeed of the case packer scans each container tag and collects electronic product code (EPC) information along with
batch and lot number data, time, and date. This information is linked to the EPC code on the RFID tag on the case. At the
entrance to the vault, case tag information is recorded along with time and event data. When the case exits the vault, the
case tag is read again. This data is time stamped and linked to a delivery number, thus creating a record of the EPC, batch
and lot number, and delivery destination of each bottle. This information not only helps identify containers that deviate
from their expected paths, but also helps identify affected containers and expedite retrieval during a recall.
Company Web sites
An e-pedigree trial undertaken with H.D. Smith (Springfield, IL) shipped tagged product and collected and transmitted chain-of-custody documentation using track-and-trace
software and collaborative data management ("SupplyScape E-pedigree" software, SupplyScape, Woburn, MA; "ES7000" data management platform, Unisys Corp., Blue Bell, PA).