Cardinal Health 2011 Annual Report Download - page 33

R
e
g
ulatory Matters
O
ur business is hi
g
hl
y
re
g
ulated in the United States at both the federal and state level and in forei
gn
countr
i
es. Depen
di
ng upon t
h
e
i
r spec
ifi
c
b
us
i
ness, our su
b
s
idi
ar
i
es may
b
esu
bj
ect to regu
l
at
i
on
b
y governmen
t
ent
i
t
i
es
i
nc
l
u
di
n
g
:
•t
h
eUn
i
te
d
States Foo
d
an
d
Drug A
d
m
i
n
i
strat
i
on (t
h
e “FDA”),
•t
h
eUn
i
te
d
States Drug En
f
orcement A
d
m
i
n
i
strat
i
on (t
h
e “DEA”),
•t
h
eUn
i
te
d
States Nuc
l
ear Regu
l
atory Comm
i
ss
i
on (t
h
e “NRC”)
,
•t
h
eUn
i
te
d
States Department o
f
Hea
l
t
h
an
d
Human Serv
i
ces (“HHS”),
• United States Customs and Border Protection
,
• state boards of pharmac
y,
• state controlled substance a
g
encies,
• state health departments, insurance departments or other comparable state a
g
encies, and
•
f
ore
ig
na
g
enc
i
es t
h
at are compara
bl
etot
h
ose
li
ste
d
a
b
ove
.
T
hese regulatory agencies have a variety of civil, administrative and criminal sanctions at their disposal
.
Th
ey can requ
i
re us to suspen
ddi
str
ib
ut
i
on o
f
pro
d
ucts an
d
contro
ll
e
d
su
b
stances or
i
n
i
t
i
ate pro
d
uct reca
ll
s; t
h
ey
can seize products or impose si
g
nificant criminal, civil and administrative sanctions; and the
y
can seek
injunctions to halt the manufacture and distribution of products.
Di
str
ib
ut
i
on. T
h
e FDA, DEA an
d
var
i
ous state aut
h
or
i
t
i
es regu
l
ate t
h
e mar
k
et
i
ng, purc
h
ase, storage an
d
d
istribution of
p
harmaceutical and medical
p
roducts and controlled substances under various state and federal
statutes
i
nc
l
u
di
ng t
h
e Prescr
i
pt
i
on Drug Mar
k
et
i
ng Act o
f
1987. W
h
o
l
esa
l
e
di
str
ib
utors o
f
contro
ll
e
d
su
b
stance
s
must
h
o
ld
va
lid
DEA reg
i
strat
i
ons an
d
state-
l
eve
lli
censes, meet var
i
ous secur
i
ty an
d
operat
i
ng stan
d
ar
d
s, an
d
compl
y
with the Federal Controlled Substances Act
g
overnin
g
the sale, marketin
g
, packa
g
in
g
, stora
g
e and
di
str
ib
ut
i
on o
f
contro
ll
e
d
su
b
stances.
O
ur Pharmaceutical se
g
ment’s China distribution operations are sub
j
ect to similar national, re
g
ional and
l
ocal re
g
ulations, includin
g
licensin
g
and re
g
ulator
y
requirements of the China Ministr
y
of Health, Ministr
y
of
C
ommerce, M
i
n
i
stry o
f
F
i
nance, t
h
e State Foo
d
an
d
Drug A
d
m
i
n
i
strat
i
on an
d
t
h
e Genera
l
A
d
m
i
n
i
strat
i
on o
f
C
ustoms.
Manufacturing and marketing. Our subsidiaries that manufacture and source medical devices are subject t
o
regu
l
at
i
on
b
yt
h
e FDA an
d
compara
bl
e
f
ore
i
gn agenc
i
es
i
nc
l
u
di
ng regu
l
at
i
ons regar
di
ng comp
li
ance w
i
t
h
goo
d
manufacturin
g
practices and qualit
y
s
y
stems. In addition, our Medical se
g
ment’s international manufacturin
g
o
perations may be subject to local certification requirements.
Th
e FDA an
d
ot
h
er
d
omest
i
can
df
ore
i
gn governmenta
l
agenc
i
es a
d
m
i
n
i
ster requ
i
rements cover
i
ng t
h
e
d
esi
g
n, testin
g
, safet
y
, effectiveness, manufacture, labelin
g
, promotion and advertisin
g
, distribution and post
-
mar
k
et surve
ill
ance o
f
some o
f
our manu
f
acture
d
pro
d
ucts. We nee
d
spec
ifi
c approva
l
or c
l
earance
f
ro
m
re
g
u
l
ator
y
aut
h
or
i
t
i
es
b
e
f
ore we can mar
k
et an
d
se
ll
man
y
o
f
our pro
d
ucts
i
n part
i
cu
l
ar countr
i
es. Even a
f
ter we
o
btain approval or clearance to market a product, the product and our manufacturin
g
processes are sub
j
ect to
cont
i
nue
d
regu
l
atory rev
i
ew.
T
o assess an
df
ac
ili
tate comp
li
ance w
i
t
hf
e
d
era
l
, state an
df
ore
ig
nre
g
u
l
ator
y
requ
i
rements, we rout
i
ne
ly
review our qualit
y
and compliance s
y
stems to evaluate their effectiveness and to identif
y
areas for improvemen
t
o
r reme
di
at
i
on. As part o
f
our qua
li
ty rev
i
ew, we assess t
h
e supp
li
ers o
f
raw mater
i
a
l
s, components an
dfi
n
i
s
h
e
d
g
oo
d
st
h
at are
i
ncorporate
di
nto t
h
eme
di
ca
ld
ev
i
ces we manu
f
acture. In a
ddi
t
i
on, we con
d
uct qua
li
t
y
mana
g
ement reviews desi
g
ned to hi
g
hli
g
ht ke
y
issues that ma
y
affect the qualit
y
of our products and services.
7