Senate
File
362
-
Introduced
SENATE
FILE
362
BY
BEALL
,
KIBBIE
,
DANIELSON
,
BEHN
,
FEENSTRA
,
DIX
,
SMITH
,
and
SORENSON
A
BILL
FOR
An
Act
relating
to
the
use
of
adult
stem
cells
in
this
state,
1
including
uses
relating
to
the
practice
of
medicine,
the
2
practice
of
pharmacy,
and
clinical
research.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
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362
Section
1.
NEW
SECTION
.
136E.1
Definitions.
1
As
used
in
this
chapter
unless
the
context
otherwise
2
requires:
3
1.
“Adult
stem
cells”
means
autologous
or
allogeneic
4
cellular
material
including
but
not
limited
to
stem
cells,
5
immune
cells,
and
other
types
of
mature
cells
that
may
have
6
been
or
may
be
combined
with
naturally
occurring
biomaterials
7
or
materials
approved
or
cleared
for
any
purpose
by
the
United
8
States
food
and
drug
administration
or
other
applicable
agency
9
or
authority.
10
2.
“Allogeneic”
means
originating
from
the
body
of
another
11
person.
12
3.
“Autologous”
means
originating
from
a
person’s
own
body.
13
4.
“Cell
or
tissue
bank”
means
a
facility
that
stores
adult
14
stem
cells
or
tissue.
15
Sec.
2.
NEW
SECTION
.
136E.2
Practices
relating
to
adult
16
stem
cells.
17
1.
Notwithstanding
any
law
to
the
contrary:
18
a.
A
person
licensed
to
practice
medicine
pursuant
to
19
chapter
148
in
this
state
may
extract,
process,
or
administer
20
autologous
adult
stem
cells.
21
b.
A
person
licensed
or
authorized
to
administer
or
assist
22
in
the
administration
of
medicine
or
health
care
in
this
state
23
may
extract,
process,
or
administer
autologous
adult
stem
24
cells
to
the
extent
permitted
under
the
person’s
license
or
25
authorization.
26
c.
A
person
may
operate
a
cell
or
tissue
bank
in
this
state.
27
d.
A
pharmacy
owned
or
operated
in
this
state,
or
a
28
pharmacist
licensed
pursuant
to
chapter
155A,
may
compound
a
29
drug,
medicine,
or
health
product
using
adult
stem
cells
as
an
30
ingredient.
31
e.
A
person
licensed
to
practice
medicine
in
this
state
may
32
conduct
adult
stem
cell
clinical
research
for
development
of
33
therapies
and
cures
consistent
with
chapter
707C.
This
chapter
34
shall
not
be
interpreted
to
limit
or
prohibit
any
activity
35
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362
otherwise
authorized
pursuant
to
chapter
707C.
1
f.
A
person
authorized
to
conduct
adult
stem
cell
clinical
2
research
in
the
state
may
import
into
this
state
any
compound
3
or
drug
containing
adult
stem
cells
if
the
compound
or
drug
is
4
obtained
in
accordance
with
the
laws
of
the
jurisdiction
from
5
which
the
compound
or
drug
is
obtained
and
the
compound
or
drug
6
is
used
for
the
purposes
of
clinical
research.
7
g.
A
person
who
is
authorized
to
extract,
process,
or
8
administer
autologous
adult
stem
cells
under
this
section
9
may
import
into
this
state
compounds
and
drugs
used
in
the
10
administration
of
such
stem
cells
if
the
compound
or
drug
is
11
obtained
in
accordance
with
the
laws
of
the
jurisdiction
from
12
which
the
compound
or
drug
is
obtained
and
the
compound
or
drug
13
is
used
for
administration
of
autologous
adult
stem
cells
to
a
14
person
in
a
treatment
plan
by
a
person
licensed
or
authorized
15
to
extract,
process,
or
administer
autologous
adult
stem
cells.
16
2.
a.
The
board
of
medicine,
the
board
of
pharmacy,
and
17
other
appropriate
licensing
boards
established
pursuant
to
18
chapter
147
shall
adopt
rules
in
accordance
with
this
chapter.
19
The
rules
adopted
shall
not
prohibit
the
activities
authorized
20
in
this
chapter
and
shall
not
impose
disciplinary
action
or
21
civil
or
criminal
penalties
against
a
person
for
engaging
22
in
any
activity
authorized
by
this
chapter.
This
paragraph
23
shall
not
be
interpreted
to
authorize
the
adoption
of
rules
24
that
absolve
a
person
from
civil
or
criminal
liability
or
25
disciplinary
action
otherwise
applicable
if
the
person
engages
26
in
an
activity
authorized
under
this
chapter
but
fails
to
use
27
the
reasonable
care,
skill,
or
knowledge
ordinarily
used
in
28
rendering
medical
services
under
similar
circumstances.
29
b.
The
board
of
medicine,
the
board
of
pharmacy,
and
other
30
appropriate
licensing
boards
may
adopt
rules
to
regulate
the
31
procedures
used
to
administer
adult
stem
cells
in
this
state.
32
EXPLANATION
33
This
bill
relates
to
the
use
of
adult
stem
cells
in
the
34
state,
including
uses
relating
to
the
practice
of
medicine,
the
35
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362
practice
of
pharmacy,
and
clinical
research.
1
The
bill
defines
terms
used
in
the
bill
and
authorizes
2
certain
activities
relating
to
adult
stem
cells.
The
bill
3
authorizes
a
person
licensed
to
practice
medicine
in
the
state
4
to
extract,
process,
or
administer
autologous
adult
stem
cells.
5
“Autologous”
means
originating
from
the
person’s
own
body.
6
The
bill
also
provides
that
a
person
licensed
or
authorized
7
to
administer
or
assist
in
the
administration
of
medicine
or
8
health
care
in
this
state
may
extract,
process,
or
administer
9
autologous
adult
stem
cells
to
the
extent
permitted
under
the
10
person’s
license
or
authorization.
11
The
bill
authorizes
all
of
the
following:
the
operation
12
of
a
cell
or
tissue
bank
in
this
state;
a
pharmacy
owned
or
13
operated
in
the
state
or
a
licensed
pharmacist
to
compound
14
a
drug,
medicine,
or
health
product
using
adult
stem
cells
15
as
an
ingredient;
a
person
licensed
to
practice
medicine
to
16
conduct
adult
stem
cell
clinical
research
for
development
of
17
therapies
and
cures
consistent
with
Code
chapter
707C
(human
18
stem
cell
research
and
cloning)
while
clarifying
that
the
19
bill
is
not
to
be
interpreted
as
limiting
or
prohibiting
20
any
activity
authorized
under
chapter
707C;
a
person
who
is
21
authorized
to
conduct
adult
stem
cell
clinical
research
to
22
import
any
compound
or
drug
containing
adult
stem
cells
if
23
the
compound
or
drug
is
obtained
in
accordance
with
the
laws
24
of
the
originating
jurisdiction
and
is
used
for
clinical
25
research;
and
a
person
who
is
authorized
to
extract,
process,
26
or
administer
autologous
adult
stem
cells
to
import
compounds
27
and
drugs
used
in
the
administration
of
such
stem
cells
if
the
28
compound
or
drug
is
obtained
in
accordance
with
the
laws
of
the
29
originating
jurisdiction
and
the
compound
or
drug
is
used
for
30
administration
of
autologous
adult
stem
cells
to
a
person
in
a
31
treatment
plan
by
a
person
licensed
or
authorized
to
extract,
32
process,
or
administer
autologous
adult
stem
cells.
33
The
bill
directs
the
board
of
medicine,
the
board
of
34
pharmacy,
and
other
appropriate
licensing
boards
to
adopt
rules
35
-3-
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2604XS
(6)
84
pf/nh
3/
4
S.F.
362
in
accordance
with
the
bill,
but
provides
that
the
rules
shall
1
not
prohibit
the
activities
authorized
in
the
bill
and
shall
2
not
impose
disciplinary
action
or
civil
or
criminal
penalties
3
against
a
person
for
engaging
in
any
activity
authorized
4
under
the
bill.
However,
the
bill
is
not
to
be
interpreted
5
to
authorize
the
adoption
of
rules
that
absolve
a
person
who
6
engages
in
an
activity
authorized
under
the
bill
from
civil
or
7
criminal
liability
or
disciplinary
action
otherwise
applicable
8
for
failure
to
use
the
reasonable
care,
skill,
or
knowledge
9
ordinarily
used
in
rendering
medical
services
under
similar
10
circumstances.
The
bill
does
authorize
the
board
of
medicine,
11
the
board
of
pharmacy
and
other
appropriate
licensing
boards
to
12
adopt
rules
to
regulate
the
procedures
used
to
administer
adult
13
stem
cells
in
this
state.
14
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