Cardinal Health 2011 Annual Report Download - page 34

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From time to time, we may determine that products we manufacture or market do not meet our specifications,
regu
l
atory requ
i
rements, or pu
bli
s
h
e
d
stan
d
ar
d
s. W
h
en we
id
ent
if
y a qua
li
ty or regu
l
atory
i
ssue, we
i
nvest
i
gate
a
nd take appropriate corrective action, such as withdrawin
g
the product from the market, correctin
g
the produc
t
a
t the customer location, revising product labeling, and notifying customers.
Nuc
l
ear p
h
armac
i
es an
d
re
l
ate
db
us
i
nesses. Our nuc
l
ear p
h
armac
i
es an
d
cyc
l
otron
f
ac
ili
t
i
es requ
i
re
li
censes
o
r permits and must abide b
y
re
g
ulations from the NRC, the radiolo
g
ic health a
g
enc
y
or department of health of
each state in which we operate, and the state board of pharmacy. In addition, the FDA regulates cyclotro
n
f
ac
ili
t
i
es an
dh
as
i
ssue
d
,e
ff
ect
i
ve Decem
b
er 2011, goo
d
manu
f
actur
i
ng pract
i
ces regu
l
at
i
ons
f
or pos
i
tro
n
emission tomo
g
raph
y
(“PET”) dru
g
s.
P
rescri
p
tion Drug Pe
d
igree Trac
k
ing an
d
Su
pply
C
h
ain Integrit
y
Th
e FDA Amen
d
ments Act o
f
2007 requ
i
res t
h
e FDA to esta
bli
s
h
stan
d
ar
d
sto
id
ent
if
yan
d
va
lid
at
e
technolo
g
ies for securin
g
the pharmaceutical suppl
y
chain a
g
ainst counterfeit dru
g
s. These standards ma
y
include
track-and-trace or authentication technologies, such as radio frequency identification devices. In March 2010, the
FDA
i
ssue
d
gu
id
ance esta
bli
s
hi
ng stan
d
ar
di
ze
d
numer
i
ca
lid
ent
ifi
ers
f
or prescr
i
pt
i
on p
h
armaceut
i
ca
l
pac
k
ages.
Some states have also ado
p
ted laws to
p
revent the introduction of counterfeit, diverted, adulterated or mislabeled
pharmaceuticals into the pharmaceutical supply chain. For example, effective July 2016, California requires that
p
h
armaceut
i
ca
l
w
h
o
l
esa
l
ers an
d
repac
k
agers
i
mp
l
ement e
l
ectron
i
c trac
k
-an
d
-trace capa
bili
t
i
es
f
or p
h
armaceut
i
ca
l
p
roducts
.
Hea
l
t
h
care Frau
d
an
d
A
b
use Laws
We are su
bj
ect to extens
i
ve an
df
requent
l
yc
h
ang
i
ng
l
aws an
d
regu
l
at
i
ons re
l
at
i
ng to
h
ea
l
t
h
care
f
rau
d
an
d
a
buse. Laws and re
g
ulations
g
enerall
y
prohibit solicitin
g
, offerin
g
, receivin
g
or pa
y
in
g
an
y
compensation in
o
rder to induce someone to order or purchase items or services that are in any way paid for by Medicare
,
Me
di
ca
id
or ot
h
er Un
i
te
d
States government-sponsore
dh
ea
l
t
h
care programs. T
h
ey a
l
so pro
hibi
tsu
b
m
i
tt
i
ng or
causin
g
to be submitted an
y
fraudulent claim for pa
y
ment b
y
the federal
g
overnment. Violations of these laws
may result in criminal or civil penalties as well as qui tam claims under the federal False Claims Act and simila
r
state acts un
d
er w
hi
c
h
pr
i
vate persons may
fil
esu
i
ton
b
e
h
a
lf
o
f
t
h
e
f
e
d
era
l
an
d
state governments.
Health and Personal Information Practice
s
S
ervices and products provided by some of our businesses, including our pharmacy services and specialt
y
p
h
armaceut
i
ca
lb
us
i
nesses,
i
nvo
l
ve access to pat
i
ent
id
ent
ifi
a
bl
e
h
ea
l
t
h
care
i
n
f
ormat
i
on. T
h
e Hea
l
t
h
Insurance
Portabilit
y
and Accountabilit
y
Act of 199
6
,asau
g
mented b
y
the Health Information Technolo
gy
for Economi
c
a
nd Clinical Health Act, as well as some state laws, regulate the use and disclosure of patient identifiable healt
h
i
n
f
ormat
i
on,
i
nc
l
u
di
ng requ
i
r
i
ng spec
ifi
e
d
pr
i
vacy an
d
secur
i
ty measures. Fe
d
era
l
an
d
state o
ffi
c
i
a
l
s
h
ave
increasin
g
l
y
focused on how patient identifiable healthcare information should be handled, secured an
d
d
isclosed
.
S
ome o
f
our
b
us
i
nesses co
ll
ect an
d
ma
i
nta
i
not
h
er persona
li
n
f
ormat
i
on t
h
at
i
ssu
bj
ect to
f
e
d
era
l
an
d
stat
e
l
aws protectin
g
such information. Securit
y
and disclosure of personal information is also hi
g
hl
y
re
g
ulated i
n
many other countries in which we operate.
E
nvironmental, Health and Sa
f
et
y
Law
s
I
n the United States and other countries, we are sub
j
ect to various federal, state and local environmental
l
aws as well as laws relating to safe working conditions, laboratory and manufacturing practices.
Laws Relating to Foreign Trade and O
p
eration
s
United States and international laws and re
g
ulations require us to abide b
y
standards relatin
g
to the import
a
nd export of finished goods, raw materials and supplies and the handling of information. We also must comply
8