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Electronic Pedigrees And Counterfeit Pharmaceuticals: The U.S. Experience With RFID
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Electronic Pedigrees And Counterfeit Pharmaceuticals: The U.S. Experience With RFID
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Description
Rating
Title
Electronic
Pedigrees
And
Counterfeit
Pharmaceuticals
: The
U.S
.
Experience
With
RFID
Author(s)
Wunder
,
Gene
C.
;
Roach
,
Bill
Description
This
paper
describes
the
process
of
implementing
an
electronic
pedigree
(e-pedigree)
system
in the
pharmaceutical
drug
supply
chain
. The
U.S
.
Congress
mandated
such
a
system
with the
Pharmaceutical
Drug
Marketing
Act
(PDMA)
of
1987
.
Congress
amended
the
PDMA
in
1992
. The
Food
and
Drug
Administration
(FDA)
delayed
requiring
compliance
with the
PDMA
until
2007
, and
even
then
complete
compliance
was not
required
. A
small
drug
wholesaler
sued
the
FDA
over
the
order
implementing
PDMA
compliance
, and
even
now
an
injunction
from a
federal
court
has
suspended
part
of the
implementation
of the
PDMA
. In the
vacuum
left
by the
federal
court
injunction
, the
State
of
California
mandated
an
e-pedigree
system
to
implement
"
track
and
trace
" for
prescription
drugs
;
later
that
year
California
suspended
the
implementation
of its
e-pedigree
law
until
2011
. This
paper
traces
the "
fits
and
starts
"
progress
of an
e-pedigree
based
on
RFID
in the
pharmaceutical
drug
supply
chain
.
It
identifies
and
describes
the
major
technical
issues
and the
major
participants
in the
political
controversy
surrounding
e-pedigree
systems
and
speculates
on the
likely
shape
of the
e-pedigree
system
that will
emerge
.
Subject
Counterfeit
Pharmaceuticals
;
Electronic
Pedigree
;
PDMA
;
Pharmaceutical
Drug
Marketing
Act
;
Pharmaceutical
Industry
;
Radio
Frequency
Identification
;
RFID
Publisher
Washburn University, School of Business
Date
July
2008
Type
Working paper
Format
PDF
Series/Report No.
School
of
Business
Working
Paper
Series
;
No
.
Language
Eng
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