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Supply Chain Information Center |
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Pedigree Legislation
Pedigree Legislation:
A Step in Securing the Pharmaceutical Supply Chain
The
vast majority of prescription drugs received by consumers are safe.
However, given the number of potential players in the supply chain and
the various laws and regulations covering each of the players, opportunities
do exist for dangerous counterfeit and adulterated drugs to enter into
the market place. In an effort to combat the risk of counterfeit
and adulterated drugs, federal and state lawmakers are pursuing drug
pedigree legislation. Under such legislation, a drug pedigree
would provide the players in the supply chain with a record detailing
the chain of custody for drugs from manufacturing to the point of dispensing.
Florida
is the first state to enact specific drug pedigree legislation, which
will be effective in July 2006. Other states will likely follow.
Although the Florida drug pedigree legislation currently regulates pharmaceutical
wholesalers and distributors, it is likely that drug manufacturers,
pharmacies, hospitals, doctors, and others will soon be required to
collect, store, and certify accurate pedigrees on the drugs they sell
and dispense.
The Electronic
Pedigree Solution
In
order to comply with drug pedigree legislation, several companies within
the pharmaceutical industry are investing in an Electronic Pedigree
solution, commonly known as “ePedigree.” A comprehensive Electronic
Pedigree solution requires three basic elements.
Tracking Products
Sensory
technologies, such as barcodes or RFID tags, are integrated into product
packaging at the manufacturer. These sensors communicate unique data
about the drug as they move through the supply chain.
Recording and Managing
Data
As
the drugs move throughout the supply chain, each player maintains complete,
accurate, and secure records of the drug pedigrees. The players must
manage and report on the volumes of data collected with the highest
degree of reliability.
Communicating the
Data with Partners
Because
so many players will have custody of the drugs as they move throughout
the supply chain, partners will need a secure environment in which to
share information, authenticate data and certify the accuracy of the
pedigrees.
To
learn more about the scope of current or emerging drug pedigree legislation
with critical information on making a implementation decision, download
our free white paper: Considerations
in Choosing a Partner for the Drug Pedigree Race
You
can also learn about the critical role that network infrastructure plays
in a comprehensive electronic pedigree solution from our free white
paper: Beyond
Pedigree: The Role of Infrastructure in the Pharmaceutical Supply Chain.
VeriSign Electronic
Pedigree Service
Many
of the leading companies actively deploying electronic pedigree solutions
have selected VeriSign as their service provider. VeriSign’s Electronic
Pedigree Service will handle an estimated 60 million pedigree transfers
in 2006 for companies representing over $118 billion in pharmaceutical
sales revenues.
VeriSign’s
customers will be able to leverage VeriSign’s intelligent infrastructure,
which enables and protects billions of interactions every day across
the world’s voice and data networks.
VeriSign
Supply Chain Services
VeriSign,
the leading provider of intelligent infrastructure services for today’s
complex, global networks, has developed an ePedigree solution to help
companies address regulations for tracking and tracing pharmaceuticals
through the supply chain.
Learn
more about solutions for the Healthcare
Industry.
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