Bill Text: IA HF2122 | 2023-2024 | 90th General Assembly | Introduced
Bill Title: A bill for an act relating to certification requirements for the provision of abortion-inducing drugs, providing penalties, and providing effective date provisions.
Spectrum: Partisan Bill (Republican 6-0)
Status: (Introduced - Dead) 2024-01-24 - Introduced, referred to Health and Human Services. H.J. 126. [HF2122 Detail]
Download: Iowa-2023-HF2122-Introduced.html
House
File
2122
-
Introduced
HOUSE
FILE
2122
BY
STOLTENBERG
,
OSMUNDSON
,
DETERMANN
,
SHERMAN
,
HAYES
,
and
HENDERSON
A
BILL
FOR
An
Act
relating
to
certification
requirements
for
the
provision
1
of
abortion-inducing
drugs,
providing
penalties,
and
2
providing
effective
date
provisions.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
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Section
1.
NEW
SECTION
.
146F.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
a.
“Abortion”
means
the
act
of
using
or
prescribing
4
any
instrument,
medicine,
drug,
or
any
other
substance,
5
device,
or
means
with
the
intent
to
terminate
a
clinically
6
diagnosable
pregnancy
with
knowledge
that
the
termination
by
7
those
means
will
with
reasonable
likelihood
cause
the
death
of
8
the
unborn
child.
“Abortion”
includes
the
act
of
prescribing
an
9
abortion-inducing
drug
with
reasonable
certainty
that
the
drug
10
will
prevent
the
growth
or
implantation,
or
otherwise
cause
the
11
death
of
the
unborn
child,
if
the
drug
is
ingested
prior
to
12
confirmation
of
a
clinically
diagnosed
pregnancy.
13
b.
“Abortion”
does
not
include
any
use,
prescribing,
14
or
means
if
done
with
the
intent
described
in
any
of
the
15
following:
16
(1)
To
save
the
life
or
preserve
the
health
of
the
unborn
17
child.
18
(2)
To
remove
a
dead
unborn
child
resulting
from
a
19
spontaneous
abortion
commonly
known
as
a
miscarriage.
20
(3)
To
remove
an
ectopic
pregnancy.
21
(4)
To
treat
a
maternal
disease
or
illness
for
which
the
22
prescribed
drug
is
medically
indicated.
23
2.
“Abortion
complication”
or
“complication”
means
only
the
24
following
physical
or
psychological
conditions
which,
in
the
25
reasonable
medical
judgment
of
a
licensed
health
care
provider,
26
arise
as
a
primary
or
secondary
result
of
an
induced
abortion:
27
uterine
perforation,
cervical
laceration,
infection,
bleeding,
28
vaginal
bleeding
that
qualifies
as
a
grade
2
or
higher
adverse
29
event
according
to
the
common
terminology
criteria
for
30
adverse
events
produced
by
the
United
States
national
cancer
31
institute,
pulmonary
embolism,
deep
vein
thrombosis,
failure
32
to
actually
terminate
the
pregnancy,
incomplete
abortion
or
33
retained
tissue,
pelvic
inflammatory
disease,
endometritis,
34
missed
ectopic
pregnancy,
cardiac
arrest,
respiratory
arrest,
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renal
failure,
shock,
amniotic
fluid
embolism,
coma,
free
1
fluid
in
the
abdomen,
allergic
reactions
to
anesthesia
and
2
abortion-inducing
drugs,
psychological
complications
as
3
diagnosed
that
are
listed
in
the
current
diagnostic
and
4
statistical
manual
and
any
termination
of
pregnancy
with
5
complications
or
abortion
with
complications
diagnosis
as
6
specified
in
current
international
classification
of
diseases
7
(ICD)
ICD-10
codes.
8
3.
a.
“Abortion-inducing
drug”
means
mifepristone,
9
misoprostol,
and
any
other
medicine,
drug,
or
other
substance
10
that
is
prescribed
or
dispensed
with
the
intent
of
terminating
11
a
clinically
diagnosable
pregnancy
with
knowledge
that
the
12
termination
will
with
reasonable
likelihood
cause
the
death
of
13
the
unborn
child.
14
b.
“Abortion-inducing
drug”
includes
all
of
the
following:
15
(1)
The
off-label
use
of
drugs
known
to
have
16
abortion-inducing
properties
which
are
prescribed
or
dispensed
17
specifically
with
the
intent
of
terminating
a
clinically
18
diagnosable
pregnancy.
19
(2)
The
off-label
use
of
drugs
known
to
have
20
abortion-inducing
properties
that
are
prescribed
without
a
21
diagnosed
pregnancy
for
the
purpose
of
causing
an
abortion
at
22
a
future
time
rather
than
contemporaneously
with
a
clinically
23
diagnosed
pregnancy.
24
c.
“Abortion-inducing
drug”
does
not
include
drugs
that
may
25
be
known
to
cause
an
abortion
but
that
are
prescribed
for
other
26
medical
indications.
27
4.
“Adverse
event”
means
the
same
as
defined
in
21
C.F.R.
28
§312.32.
29
5.
“Associated
physician”
means
a
physician
who
has
entered
30
into
an
associated
physician
contract
with
another
physician
31
under
this
chapter
to
provide
for
hospital
admitting
privileges
32
as
required
under
this
chapter.
33
6.
“Department”
means
the
department
of
inspections,
34
appeals,
and
licensing.
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7.
“Distributor”
means
the
same
as
wholesale
distributor
as
1
defined
in
section
155A.3.
2
8.
“Facility”
means
a
public
or
private
hospital,
clinic,
3
center,
medical
school,
medical
training
institution,
health
4
care
business,
physician
office,
infirmary,
dispensary,
5
ambulatory
surgical
center,
or
other
institution
or
location
or
6
business
wherein
medical
care
or
pharmaceuticals
are
provided
7
to
any
person.
8
9.
“Gestational
age”
means
the
time
that
has
elapsed
since
9
the
first
day
of
the
pregnant
woman’s
last
menstrual
period.
10
10.
“Health
care
provider”
means
a
person
who
is
licensed,
11
certified,
or
otherwise
authorized
or
permitted
by
law
of
this
12
state
to
administer
health
care
in
the
ordinary
course
of
13
business
or
in
the
practice
of
a
profession.
14
11.
“Hospital”
means
the
same
as
defined
in
section
135B.1.
15
12.
“Manufacturer”
means
the
same
as
defined
in
section
16
155A.3.
17
13.
“Pharmacy”
means
a
pharmacy
as
defined
in
section
18
155A.3
located
in
that
state
that
is
also
certified
by
the
19
manufacturers
of
abortion-inducing
drugs
to
dispense
the
drugs
20
via
prescription.
21
14.
“Physician”
means
a
person
licensed
to
practice
pursuant
22
to
chapter
148.
23
15.
“Pregnant”
or
“pregnancy”
means
the
female
reproductive
24
condition
of
having
an
unborn
child
in
the
female’s
uterus.
25
16.
“Provide”
,
“provided”
,
or
“providing”
means,
when
used
26
regarding
abortion-inducing
drugs,
any
act
of
giving,
selling,
27
dispensing,
administering,
transferring
possession
to,
or
28
otherwise
providing
or
prescribing
an
abortion-inducing
drug.
29
Sec.
2.
NEW
SECTION
.
146F.2
Applicability.
30
This
chapter
applies
to
any
physician,
health
care
provider,
31
manufacturer,
distributor,
pharmacy,
or
other
person
providing
32
abortion-inducing
drugs
within
the
state.
33
Sec.
3.
NEW
SECTION
.
146F.3
Abortion-inducing
drug
34
certification
program
——
creation.
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1.
The
board
of
pharmacy
shall
create
an
abortion-inducing
1
drug
certification
program
to
provide
oversight
and
to
regulate
2
the
provision
of
abortion-inducing
drugs
in
the
state.
3
2.
Abortion-inducing
drugs
shall
be
transported
and
4
provided
in
the
state
at
wholesale
only
by
manufacturers
or
5
distributors
certified
under
the
program.
6
3.
Abortion-inducing
drugs
shall
only
be
provided
to
7
patients
by
physicians
certified
to
prescribe
and
dispense
the
8
drugs
under
the
program.
9
4.
Abortion-inducing
drugs
shall
not
be
provided
directly
10
to
a
patient
outside
of
the
program,
including
through
the
11
mail.
12
Sec.
4.
NEW
SECTION
.
146F.4
Board
of
pharmacy
——
13
abortion-inducing
drug
certification
program
duties.
14
1.
The
board
of
pharmacy
shall
require
all
of
the
following
15
at
a
minimum
from
manufacturers,
distributors,
and
pharmacies
16
in
the
state
that
provide
abortion-inducing
drugs:
17
a.
Completion
of
the
certification
process
for
18
manufacturers,
distributors,
physicians,
and
pharmacies
as
19
described
under
this
chapter.
20
b.
Notification
by
manufacturers,
distributors,
and
21
pharmacies
of
the
physicians
certified
under
the
program.
22
c.
Compliance
with
reporting
requirements
as
specified
under
23
this
chapter.
24
d.
Prohibited
shipment
of
abortion-inducing
drugs
to
25
physicians
who
are
not
certified
under
the
program.
26
e.
Auditing
of
newly
certified
manufacturers,
distributors,
27
and
pharmacies
within
ninety
calendar
days
following
initial
28
certification
and
annually
thereafter,
to
ensure
compliance
29
with
the
processes
and
procedures
required
under
the
program.
30
f.
Suspension
of
the
certification
of
a
manufacturer,
31
distributor,
or
pharmacy
found
to
be
noncompliant
until
the
32
manufacturer,
distributor,
or
pharmacy
demonstrates
full
33
compliance.
34
g.
Enforcement
of
certification
compliance
in
accordance
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with
this
chapter.
1
2.
The
board
of
pharmacy
shall
require
all
of
the
following
2
at
a
minimum
from
physicians
in
the
state
who
provide
3
abortion-inducing
drugs:
4
a.
Completion
of
the
certification
process.
5
b.
Auditing
of
newly
certified
physicians
within
ninety
6
calendar
days
following
initial
certification
and
annually
7
thereafter,
to
ensure
compliance
with
the
processes
and
8
procedures
required
under
the
program.
9
c.
Suspension
of
the
certification
of
a
physician
found
10
to
be
noncompliant
until
the
physician
demonstrates
full
11
compliance.
12
d.
Enforcement
of
certification
compliance
in
accordance
13
with
this
chapter.
14
3.
The
board
of
pharmacy
shall
require
that
all
15
manufacturers
of
abortion-inducing
drugs
submit
a
list
of
any
16
manufacturers,
distributors,
pharmacies,
and
physicians
that
17
are
certified
or
otherwise
approved
by
the
manufacturer
of
18
abortion-inducing
drugs
to
dispense
the
drugs
in
the
state.
19
Sec.
5.
NEW
SECTION
.
146F.5
Certification
program
20
requirements
for
manufacturers,
distributors,
and
pharmacies.
21
1.
The
board
of
pharmacy
shall
create
a
certification
22
program
for
manufacturers,
distributors,
and
pharmacies
23
intending
to
provide
abortion-inducing
drugs
in
the
state.
24
2.
To
be
eligible
for
certification
under
this
section,
25
a
manufacturer,
distributor,
or
pharmacy
shall
do
all
of
the
26
following,
as
applicable:
27
a.
Be
licensed
by
the
board
of
pharmacy.
28
b.
Only
distribute
abortion-inducing
drugs
to
physicians
29
certified
under
this
chapter.
30
c.
Record
each
national
drug
code,
serial
number,
lot
31
number,
and
expiration
date
from
the
pharmaceutical
packages
32
of
abortion-inducing
drugs
distributed
to
each
certified
33
physician.
34
d.
Only
dispense
abortion-inducing
drugs
to
patients
based
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on
prescriptions
by
physicians
certified
under
this
chapter.
1
e.
Only
dispense
a
prescription
for
abortion-inducing
drugs
2
to
a
patient
if
the
prescription
is
accompanied
by
a
patient
3
agreement
form
signed
by
the
patient.
4
f.
Have
available
for
examination
the
certification
required
5
by
the
manufacturer
of
abortion-inducing
drugs.
6
g.
Comply
with
all
applicable
standards
of
the
utilization
7
review
accreditation
commission
and
the
national
association
of
8
the
boards
of
pharmacy.
9
h.
For
online
sales
or
orders,
hold
a
current
pharmacy
or
10
pharma
domain
and
comply
with
all
standards
required
by
the
11
national
association
of
the
boards
of
pharmacy
to
maintain
the
12
domain.
13
i.
Comply
with
all
other
applicable
state
and
federal
14
laws
related
to
the
distribution
or
delivery
of
legend
drugs,
15
including
abortion-inducing
drugs.
16
j.
Comply
with
all
acceptable
processes
and
procedures
to
17
maintain
a
distribution
or
delivery
system
that
is
secure,
18
confidential,
and
follows
all
processes
and
procedures,
19
including
those
for
storage,
handling,
shipping,
tracking
of
20
national
drug
codes,
serial
numbers,
lot
numbers
and
expiration
21
dates
on
products,
proof
of
delivery,
and
controlled
returns
of
22
abortion-inducing
drugs.
23
Sec.
6.
NEW
SECTION
.
146F.6
Certification
program
24
requirements
for
physicians.
25
1.
The
board
of
pharmacy
shall
create
a
certification
26
program
for
physicians
intending
to
provide
abortion-inducing
27
drugs
to
pregnant
women
in
the
state.
Physicians
providing
28
abortion-inducing
drugs
in
other
states
shall
not
be
29
automatically
certified
in
Iowa
but
shall
be
fully
certified
30
under
this
chapter
prior
to
providing
any
abortion-inducing
31
drugs
to
any
pregnant
women
in
this
state.
To
be
eligible
to
be
32
certified
under
this
section,
a
physician
shall
comply
with
all
33
of
the
following:
34
a.
Hold
a
license
to
practice
medicine
in
good
standing
in
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the
state.
1
b.
Examine
any
pregnant
woman
in
person
prior
to
prescribing
2
or
dispensing
an
abortion-inducing
drug.
3
c.
Present
and
continually
hold
a
current
prescriber
4
agreement
form
with
the
manufacturer
of
each
abortion-inducing
5
drug
prescribed
by
the
physician
in
accordance
with
guidelines
6
of
the
United
States
food
and
drug
administration.
7
d.
Sign
an
annual
dispensing
agreement
form
developed
8
and
provided
by
the
board
of
pharmacy
before
providing
9
abortion-inducing
drugs.
10
e.
Obtain
the
signature
of
the
pregnant
woman
to
whom
an
11
abortion-inducing
drug
is
dispensed
on
the
patient
agreement
12
form
required
by
the
manufacturer
of
each
abortion-inducing
13
drug
used
in
accordance
with
the
guidelines
of
the
United
14
States
food
and
drug
administration.
15
f.
Attach
the
signed
patient
agreement
form
to
any
16
prescription
for
an
abortion-inducing
drug
issued
to
a
17
certified
pharmacy.
18
g.
Inform
the
pregnant
woman
to
whom
the
abortion-inducing
19
drug
is
to
be
dispensed
of
gestational
age-specific
risks
of
20
using
abortion-inducing
drugs.
21
h.
Screen
the
pregnant
woman
to
whom
the
abortion-inducing
22
drug
is
to
be
dispensed
for
coercion,
abuse,
and
anxiety,
23
and
refer
the
pregnant
woman
to
the
appropriate
health
care
24
provider
for
treatment
consistent
with
the
screening
results.
25
i.
Inform
the
pregnant
woman
to
whom
an
abortion-inducing
26
drug
is
to
be
dispensed
that
the
pregnant
woman
may
see
the
27
remains
of
the
unborn
child
in
the
process
of
completing
the
28
abortion,
that
it
may
be
possible
to
reverse
the
effects
of
29
the
drug-induced
abortion
if
the
pregnant
woman
changes
her
30
mind
but
that
time
is
of
the
essence,
that
studies
show
that
31
babies
born
following
the
abortion
reversal
process
do
not
have
32
a
higher
rate
of
birth
defects
than
the
general
population,
33
and
that
studies
show
that
following
the
reversal
process
or
34
otherwise
treating
a
pregnant
woman
with
progesterone
during
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pregnancy
does
not
lead
to
increased
mortality
rates.
1
j.
Refrain
from
knowingly
supplying
abortion-inducing
drugs
2
to
persons
who
present
with
any
of
the
following:
3
(1)
Absence
of
a
pregnancy.
4
(2)
Being
post-seventy
days
gestation
or
post-ten
weeks
of
5
pregnancy.
6
(3)
Having
risk
factors
medically
contraindicated
for
7
taking
abortion-inducing
drugs,
including
but
not
limited
to
8
any
of
the
following:
9
(a)
An
ectopic
pregnancy.
10
(b)
Problems
with
the
adrenal
glands
near
the
kidneys.
11
(c)
Being
treated
with
long-term
corticosteroid
therapy.
12
(d)
Allergic
reactions
to
abortion-inducing
drugs,
13
mifepristone,
misoprostol,
or
similar
drugs.
14
(e)
Bleeding
problems,
anemia,
or
taking
anticoagulant
drug
15
products.
16
(f)
Having
inherited
porphyria.
17
(g)
Having
an
intrauterine
device
in
place.
18
(h)
Being
Rh
negative
and
requiring
the
administration
of
19
Rhogam
before
providing
abortion-inducing
drugs.
20
k.
Provide
or
refer
the
pregnant
woman
for
emergency
21
surgical
intervention
in
cases
of
an
incomplete
abortion,
22
severe
bleeding,
or
other
medical
complications,
through
23
maintenance
of
hospital
admitting
privileges
or
through
a
24
written
agreement
with
an
associated
physician
as
specified
in
25
this
chapter.
26
l.
Ensure
the
pregnant
woman
access
to
medical
facilities
27
equipped
to
provide
blood
transfusions
and
resuscitation
or
28
other
necessary
treatments,
if
necessary.
29
m.
Sign
and
ensure
that
the
pregnant
woman
signs
all
30
required
informed
consent
materials,
provide
the
pregnant
31
woman
with
a
copy
of
the
signed
consent
materials
showing
both
32
signatures,
and
place
the
original
signed
consent
materials
in
33
the
pregnant
woman’s
medical
record.
34
n.
Record
the
national
drug
code,
serial
number,
lot
number,
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and
expiration
date
from
the
package
of
each
abortion-inducing
1
drug
provided
to
the
pregnant
woman
in
the
pregnant
woman’s
2
medical
record.
3
o.
Submit
a
written
protocol
of
efforts
that
will
be
made
4
to
schedule
the
follow-up
appointment
with
the
pregnant
woman
5
within
fourteen
days
to
assure
a
completed
abortion.
6
p.
Report
to
the
board
of
pharmacy
and
the
United
States
7
food
and
drug
administration
any
death
associated
with
the
8
physician’s
provision
of
abortion-inducing
drugs
to
a
pregnant
9
woman
with
the
following
guidelines:
10
(1)
The
pregnant
woman
shall
be
referenced
in
the
report
11
by
a
nonidentifiable
reference
and
the
national
drug
code,
12
lot
number,
and
expiration
date
from
the
package
of
the
13
abortion-inducing
drug
given,
whether
or
not
considered
drug
14
related.
15
(2)
The
report
shall
be
submitted
as
soon
as
possible
but
no
16
later
than
fifteen
calendar
days
from
the
initial
receipt
of
17
the
information
by
the
physician.
18
q.
Submit
a
written
protocol
of
how
complications
will
be
19
handled
by
the
physician
and
a
copy
of
any
signed
contract
20
with
an
associated
physician
credentialed
to
handle
certain
21
complications
specified
in
this
chapter
to
the
board
of
22
pharmacy.
23
r.
Comply
with
all
applicable
state
and
federal
laws
24
regarding
medical
records
retention,
confidentiality,
and
25
privacy.
26
s.
Agree
to
follow
and
document
compliance
with
all
other
27
required
conditions
for
performing
abortions
in
the
state.
28
2.
The
requirements
under
this
subsection
do
not
affect
29
the
other
reporting
requirements
for
a
physician
under
the
30
abortion-inducing
drugs
certification
program
or
any
other
31
applicable
law.
32
Sec.
7.
NEW
SECTION
.
146F.7
Hospital
admitting
privileges
33
——
associated
physician
agreements
——
requirements.
34
The
board
of
pharmacy
shall
require
all
of
the
following
of
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physicians
certified
under
this
chapter:
1
1.
Maintain
hospital
admitting
privileges
at
one
or
more
2
hospitals
in
the
county
or
a
contiguous
county
where
the
3
abortion-inducing
drug
is
provided
by
the
physician,
and
inform
4
the
pregnant
woman
of
any
hospital
where
the
physician
holds
5
admitting
privileges.
6
2.
a.
In
lieu
of
subsection
1,
enter
into
a
written
7
agreement
with
an
associated
physician
in
the
county
or
a
8
contiguous
county
where
the
abortion-inducing
drug
is
provided
9
to
comply
with
the
requirements
for
maintenance
of
hospital
10
admitting
privileges.
A
physician
who
enters
into
such
written
11
agreement
shall
ensure
compliance
with
all
of
the
following:
12
(1)
The
physician
who
provides
an
abortion-inducing
drug
13
shall
notify
the
pregnant
woman
of
the
location
of
any
hospital
14
at
which
the
associated
physician
has
admitting
privileges.
15
(2)
The
physician
shall
keep
a
copy
of
the
written
agreement
16
at
the
physician’s
practice
location.
17
(3)
The
physician
shall
submit
a
copy
of
the
written
18
agreement
to
the
department
as
part
of
any
required
facility
19
licensure.
20
(4)
The
written
agreement
shall
be
renewed
annually.
21
(5)
The
written
agreement
shall
include
a
requirement
22
that
the
associated
physician
present
and
continually
23
hold
any
certifications
required
by
the
manufacturers
of
24
abortion-inducing
drugs.
25
(6)
The
written
agreement
shall
include
a
requirement
26
that
the
associated
physician
provide
to
the
pregnant
woman
27
and
require
the
pregnant
woman
to
sign
all
informed
consent
28
materials
required
by
the
state.
29
(7)
The
written
agreement
shall
require
the
compliance
by
30
the
associated
physician
with
all
reporting
requirements
and
31
any
other
required
conditions
for
performing
abortions
in
the
32
state.
33
b.
(1)
The
board
of
pharmacy
shall
verify
the
validity
of
34
the
written
agreement
and
shall
provide
a
copy
of
each
written
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agreement
to
the
department.
1
(2)
The
department
shall
annually
submit
a
copy
of
each
2
written
agreement
to
each
hospital
located
in
the
county
or
a
3
county
that
is
contiguous
to
the
county
where
an
abortion
was
4
performed.
5
(3)
The
department
shall
confirm
to
a
member
of
the
public,
6
upon
request,
that
the
written
agreement
required
under
this
7
section
has
been
received
by
the
department.
8
Sec.
8.
NEW
SECTION
.
146F.8
Reporting
system
——
annual
9
reports
——
reports
of
abortion
complications
or
adverse
events
——
10
requirements
for
certified
physicians
and
others.
11
1.
The
board
of
pharmacy
shall
adopt
an
electronically
based
12
reporting
system
for
physicians
certified
under
this
chapter
to
13
report
annually
all
of
the
following
regarding
the
provision
of
14
abortion-inducing
drugs:
15
a.
The
number
of
pregnant
women
provided
abortion-inducing
16
drugs.
17
b.
The
age
of
each
pregnant
woman
provided
abortion-inducing
18
drugs.
19
c.
The
race
of
each
pregnant
woman
provided
20
abortion-inducing
drugs.
21
d.
The
county
and
state
of
residence
of
each
pregnant
woman
22
provided
abortion-inducing
drugs.
23
e.
If
a
pregnant
woman
resides
outside
of
the
United
States,
24
the
city
and
country
of
residence
of
each
such
pregnant
woman
25
provided
abortion-inducing
drugs.
26
f.
The
county
and
state
in
which
each
pregnant
woman
was
27
provided
abortion-inducing
drugs.
28
g.
A
list
of
the
staff
attending
the
pregnant
woman
provided
29
abortion-inducing
drugs,
including
licensing
numbers
and
30
evidence
of
other
qualifications.
31
h.
The
abortion-inducing
drug
provided
for
each
pregnant
32
woman,
by
date.
33
i.
Any
known
abortion
complications
or
adverse
events
34
experienced
by
a
pregnant
woman
following
provision
of
the
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abortion-inducing
drug,
and
how
the
abortion
complications
or
1
adverse
events
were
addressed,
by
date.
2
j.
Any
unresolved
cases.
3
2.
Emergency
department
physicians
and
other
physicians
4
who
treat
abortion
complications
or
adverse
events
shall
also
5
report
these
instances
to
the
reporting
system.
6
3.
A
physician
reporting
under
this
section
shall
protect
7
from
disclosure
any
personally
identifiable
information
of
the
8
pregnant
woman
in
accordance
with
applicable
federal
and
state
9
law.
10
4.
A
certified
physician
shall
also
report
to
the
board
11
of
pharmacy,
as
well
as
the
MedWatch
reporting
system
of
12
the
United
States
food
and
drug
administration
any
abortion
13
complication
or
adverse
event
as
defined
by
the
United
States
14
food
and
drug
administration
in
the
MedWatch
reporting
system.
15
5.
A
certified
physician
shall
also
report
to
the
board
16
of
pharmacy
any
death
of
a
pregnant
woman
associated
with
17
abortion-inducing
drugs
in
accordance
with
the
following
18
guidelines:
19
a.
The
pregnant
woman
shall
be
identified
by
a
20
nonidentifiable
reference
and
the
national
drug
code,
serial
21
number,
lot
number,
and
expiration
date
from
each
package
of
22
the
abortion-inducing
drug
provided,
whether
or
not
the
death
23
is
considered
drug
related.
24
b.
The
report
shall
be
submitted
as
soon
as
possible
but
no
25
later
than
fifteen
calendar
days
from
the
initial
receipt
of
26
the
information
by
the
physician.
27
6.
The
reporting
requirements
under
this
section
are
in
28
addition
to
any
other
reporting
requirements
applicable
to
a
29
physician
under
this
chapter
or
any
other
required
conditions
30
for
performing
an
abortion
in
the
state.
31
7.
The
board
of
pharmacy
shall
develop
a
system
of
reporting
32
abortion
complications
and
adverse
events
resulting
from
the
33
use
of
abortion-inducing
drugs
in
the
state.
34
a.
The
system
shall
require
reporting
of
abortion
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complications
and
adverse
events,
including
but
not
limited
to
1
death,
blood
loss
including
hemorrhage,
infection
including
2
sepsis,
blood
transfusions,
administration
of
drugs
for
3
an
ectopic
pregnancy,
and
other
adverse
effects
requiring
4
hospitalization
or
additional
medical
care.
5
b.
All
of
the
following
persons
shall
report
abortion
6
complications
and
adverse
events
in
writing
to
the
system:
7
(1)
Physicians
certified
to
provide
abortion-inducing
8
drugs.
9
(2)
Emergency
department
physicians.
10
(3)
Any
physician
licensed
in
the
state
who
treats
women
11
with
adverse
abortion
complications
or
adverse
effects.
12
(4)
Other
persons
as
determined
by
the
board
of
pharmacy.
13
c.
A
person
required
report
so
shall
also
report
adverse
14
events
and
patient
deaths
to
the
United
States
food
and
drug
15
administration.
16
Sec.
9.
NEW
SECTION
.
146F.9
Violations
——
penalties
——
17
remedies.
18
1.
A
manufacturer,
distributor,
physician,
or
pharmacist
19
shall
not
provide
abortion-inducing
drugs
without
being
20
certified
as
required
by
this
chapter.
21
2.
A
manufacturer,
distributor,
physician,
or
pharmacist
22
who
knowingly,
intentionally,
or
recklessly
violates
this
23
chapter
is
guilty
of
a
class
“D”
felony.
24
3.
A
manufacturer,
distributor,
physician,
or
pharmacist
25
who
knowingly,
intentionally,
or
recklessly
violates
this
26
chapter
by
fraudulent
use
of
an
abortion-inducing
drug,
with
or
27
without
the
knowledge
of
the
pregnant
woman,
is
guilty
of
an
28
aggravated
misdemeanor.
29
4.
a.
In
addition
to
any
other
remedies
available
under
30
common
or
state
law,
failure
to
comply
with
the
requirements
of
31
this
chapter
shall
result
in
all
of
the
following:
32
(1)
A
basis
for
a
civil
malpractice
action
for
actual
and
33
punitive
damages.
34
(2)
A
basis
for
a
professional
disciplinary
action
by
the
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appropriate
licensing
board
or
other
entity.
1
(3)
A
basis
for
recovery
following
a
pregnant
woman’s
death
2
for
the
woman’s
survivors
pursuant
to
a
wrongful
death
action.
3
b.
When
requested,
the
court
shall
allow
a
pregnant
woman
4
to
proceed
using
solely
the
woman’s
initials
or
a
pseudonym
5
and
may
close
any
proceedings
in
the
case
and
enter
other
6
protective
orders
to
preserve
the
privacy
of
the
pregnant
woman
7
upon
whom
the
drug-induced
abortion
was
attempted,
induced,
or
8
performed.
9
c.
(1)
If
judgment
is
rendered
in
favor
of
the
plaintiff,
10
the
court
shall
also
award
reasonable
attorney
fees
in
favor
11
of
the
plaintiff.
12
(2)
If
judgment
is
rendered
in
favor
of
the
defendant
and
13
the
court
finds
that
the
plaintiff’s
suit
was
frivolous
and
14
brought
in
bad
faith,
the
court
may
award
reasonable
attorney
15
fees
in
favor
of
the
defendant.
16
5.
A
civil
or
criminal
penalty
shall
not
be
assessed
17
against
a
pregnant
woman
upon
whom
a
drug-induced
abortion
is
18
attempted,
induced,
or
performed.
19
Sec.
10.
NEW
SECTION
.
146F.10
Enforcement
by
the
board
of
20
pharmacy.
21
1.
The
board
of
pharmacy
shall
enforce
this
chapter
by
any
22
of
the
following
means:
23
a.
When
a
manufacturer,
distributor,
physician,
24
or
pharmacist
intentionally
or
knowingly
provides
25
abortion-inducing
drugs
without
first
seeking
certification
26
under
this
chapter
in
violation
of
this
chapter,
the
board
of
27
pharmacy
shall
do
all
of
the
following:
28
(1)
Immediately
report
the
illegal
act
to
local
law
29
enforcement
or
other
applicable
state
and
local
agencies
for
30
investigation
and
other
appropriate
action,
where
appropriate.
31
(2)
Impose
a
fine
of
no
less
than
five
million
dollars
for
32
manufacturers,
distributors,
or
pharmacies
and
two
hundred
33
fifty
thousand
dollars
for
physicians.
34
b.
When
a
certified
manufacturer,
distributor,
pharmacy,
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or
physician
is
determined
to
be
in
noncompliance,
suspend
1
certification
until
full
compliance
is
demonstrated
to
the
2
satisfaction
of
the
board
of
pharmacy.
3
c.
When
a
current
or
previously
certified
manufacturer,
4
distributor,
or
pharmacy
is
found
to
have
intentionally
5
or
knowingly
violated
this
chapter
or
refuses
to
be
fully
6
compliant
within
ninety
calendar
days,
suspend
certification
7
and
prohibit
continued
provision
of
abortion-inducing
drugs
8
by
the
manufacturer,
distributor,
or
pharmacy
until
full
9
compliance
is
demonstrated
to
the
satisfaction
of
the
board
of
10
pharmacy.
11
d.
When
a
certified
manufacturer,
distributor,
pharmacy,
12
or
physician
is
in
noncompliance,
suspend
all
annual
13
recertifications
until
compliance
is
demonstrated
to
the
14
satisfaction
of
the
board
of
pharmacy.
15
e.
When
a
current
or
previously
certified
manufacturer,
16
distributor,
pharmacy,
or
physician
is
found
to
have
17
intentionally
or
knowingly
violated
this
chapter
or
refuses
to
18
be
fully
compliant:
19
(1)
Immediately
suspend
the
manufacturer’s,
distributor’s,
20
pharmacy’s,
or
physician’s
certification
until
full
compliance
21
is
demonstrated.
22
(2)
For
certified
manufacturers,
distributors,
or
23
pharmacies,
impose
fines
of
not
less
than
one
million
dollars
24
per
offense.
25
(3)
For
certified
physicians,
impose
fines
of
not
less
than
26
one
hundred
thousand
dollars
per
offense.
27
(4)
Permanently
revoke
the
certification
of
the
offender
if
28
the
offender
fails
to
demonstrate
full
compliance
within
ninety
29
calendar
days.
30
(5)
Impose
remedial
actions,
which
may
include
additional
31
education,
additional
reporting,
or
other
actions
as
required
32
by
the
board
of
pharmacy.
33
(6)
In
the
case
of
a
licensed
manufacturer,
distributor,
or
34
pharmacy,
recommend
sanctioning
to
the
appropriate
licensing
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board
or
other
entity.
1
(7)
In
the
case
of
a
physician,
report
the
violation
and
2
recommend
appropriate
sanctioning
to
the
board
of
medicine.
3
(8)
Publicly
report
any
disciplinary
actions
consistent
4
with
the
practices
of
the
appropriate
licensing
board
or
other
5
entity.
6
(9)
Permanently
revoke
the
certification
of
the
offender.
7
(10)
In
the
case
of
a
licensed
manufacturer,
distributor,
or
8
pharmacy,
recommend
permanent
revocation
of
licensure.
9
(11)
In
the
case
of
a
licensed
physician,
recommend
10
appropriate
sanctioning
to
the
board
of
medicine.
11
2.
A
person
shall
have
a
private
right
of
action
to
seek
12
restitution
in
any
court
of
law
with
appropriate
jurisdiction
13
for
any
damages
suffered
due
to
a
violation
of
this
chapter.
14
Sec.
11.
NEW
SECTION
.
146F.11
Online
public
portal.
15
1.
The
board
of
pharmacy
shall
develop
on
its
internet
16
site
a
complaint
portal
for
patients,
pharmacies,
health
care
17
providers,
and
the
public
to
submit
information
about
potential
18
violations
at
no
cost.
19
2.
The
portal
shall
list
the
names
of
manufacturers,
20
distributors,
pharmacies,
and
physicians
certified
under
the
21
program.
22
3.
The
portal
shall
allow
a
person
to
make
a
complaint
23
anonymously.
24
4.
The
board
of
pharmacy
shall
review
each
complaint
and
25
determine
a
disposition,
including
a
referral
to
another
26
appropriate
entity,
within
thirty
days
of
receipt
of
the
27
complaint.
28
5.
Confidentiality
of
the
originator
of
the
complaint
shall
29
be
protected
at
all
times
except
for
intrastate
referrals
for
30
investigation.
31
Sec.
12.
NEW
SECTION
.
146F.12
Construction.
32
1.
This
chapter
shall
not
be
construed
as
creating
or
33
recognizing
a
right
to
abortion.
34
2.
It
is
not
the
intention
of
this
chapter
to
make
lawful
an
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abortion
that
is
otherwise
unlawful.
1
3.
This
chapter
does
not
repeal,
replace,
or
otherwise
2
invalidate
existing
federal
or
state
laws,
regulations,
or
3
policies.
4
Sec.
13.
NEW
SECTION
.
146F.13
Right
to
enforce
or
intervene
5
by
attorney
general.
6
The
attorney
general
may
bring
an
action
to
enforce
7
compliance
with
this
chapter
or
intervene
as
a
matter
of
right
8
in
any
case
in
which
the
constitutionality
of
this
chapter
is
9
challenged.
10
Sec.
14.
NEW
SECTION
.
146F.14
Severability.
11
If
any
provision
of
this
chapter
or
its
application
to
any
12
person
or
circumstance
is
held
invalid,
the
invalidity
does
13
not
affect
other
provisions
or
applications
of
this
chapter
14
which
can
be
given
effect
without
the
invalid
provision
or
15
application,
and
to
this
end
the
provisions
of
this
chapter
are
16
severable.
17
Sec.
15.
EFFECTIVE
DATE.
This
Act,
being
deemed
of
18
immediate
importance,
takes
effect
upon
enactment.
19
EXPLANATION
20
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
21
the
explanation’s
substance
by
the
members
of
the
general
assembly.
22
This
bill
relates
to
certification
requirements
relating
to
23
the
provision
of
abortion-inducing
drugs.
24
The
bill
provides
definitions
used
in
the
bill
and
creates
25
a
new
Code
chapter
that
applies
to
any
physician,
health
care
26
provider,
manufacturer,
distributor,
pharmacy,
or
other
person
27
providing
abortion-inducing
drugs
within
the
state.
28
The
bill
provides
that
the
board
of
pharmacy
shall
create
29
an
abortion-inducing
drug
certification
program
to
provide
30
oversight
and
to
regulate
the
provision
of
abortion-inducing
31
drugs
in
the
state.
Abortion-inducing
drugs
shall
be
32
transported
and
provided
in
the
state
at
wholesale
only
by
33
certified
manufacturers
or
distributors;
abortion-inducing
34
drugs
shall
only
be
provided
to
patients
by
certified
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physicians;
and
abortion-inducing
drugs
shall
not
be
provided
1
directly
to
a
patient
outside
of
the
program
including
through
2
the
mail.
3
The
bill
directs
the
board
of
pharmacy
to
establish
a
4
certification
system
with
certain
minimum
measures
relating
5
to
manufacturers,
distributors,
pharmacies,
and
physicians
6
who
provide
abortion-inducing
drugs
in
the
state.
The
bill
7
specifies
requirements
of
manufacturers,
distributors,
8
physicians,
and
pharmacists
who
provide
abortion-inducing
drugs
9
in
the
state
under
the
state
certification
program.
10
The
bill
requires
that
a
physician
certified
under
the
bill
11
either
shall
maintain
hospital
admitting
privileges
at
one
or
12
more
hospitals
in
the
county
or
a
contiguous
county
where
the
13
abortion-inducing
drug
is
provided
by
the
physician
or
enter
14
into
a
written
agreement
with
an
associated
physician
who
has
15
such
privileges.
The
bill
specifies
the
requirements
for
such
16
written
agreement.
17
The
bill
requires
the
board
of
pharmacy
to
create
an
18
electronically
based
reporting
system
for
physicians
certified
19
under
the
bill
to
report
annually
certain
information
regarding
20
the
provision
of
abortion-inducing
drugs.
The
bill
also
21
requires
emergency
department
physicians
and
other
physicians
22
who
treat
abortion
complications
or
adverse
events
to
report
23
these
instances
to
the
reporting
system.
24
The
bill
requires
certified
physicians
to
report
to
the
25
board
of
pharmacy,
as
well
as
the
MedWatch
reporting
system
of
26
the
United
States
food
and
drug
administration,
any
abortion
27
complication
or
adverse
event
as
defined
by
the
United
States
28
food
and
drug
administration
in
the
MedWatch
reporting
system.
29
The
bill
requires
certified
physicians
to
report
to
the
board
30
of
pharmacy
any
death
of
a
pregnant
woman
associated
with
31
abortion-inducing
drugs.
The
reporting
requirements
under
32
the
bill
are
in
addition
to
any
other
reporting
requirements
33
applicable
to
a
physician
under
the
bill
or
any
other
required
34
conditions
for
performing
abortions
in
the
state.
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The
bill
requires
the
board
of
pharmacy
to
develop
a
1
system
of
reporting
abortion
complications
and
adverse
events
2
resulting
from
the
use
of
abortion-inducing
drugs
in
the
state.
3
Physicians
certified
to
provide
abortion-inducing
drugs,
4
emergency
department
physicians,
and
any
physicians
licensed
in
5
the
state
who
treat
women
with
adverse
abortion
complications
6
or
adverse
effects,
and
other
persons
as
determined
by
the
7
board
of
pharmacy
shall
report
abortion
complications
and
8
adverse
events
to
the
system.
A
person
required
to
do
so
shall
9
also
report
adverse
events
and
patient
deaths
to
the
United
10
States
food
and
drug
administration.
11
The
bill
provides
penalties
and
remedies
for
violations
12
of
the
bill.
A
manufacturer,
distributor,
physician,
or
13
pharmacist
who
intentionally,
knowingly,
or
recklessly
violates
14
the
bill
is
guilty
of
a
class
“D”
felony.
A
class
“D”
felony
15
is
punishable
by
confinement
for
no
more
than
five
years
and
a
16
fine
of
at
least
$1,025
but
not
more
than
$10,245.
17
A
manufacturer,
distributor,
physician,
or
pharmacist
who
18
intentionally,
knowingly,
or
recklessly
violates
the
bill
by
19
fraudulent
use
of
an
abortion-inducing
drug,
with
or
without
20
the
knowledge
of
the
pregnant
woman,
is
guilty
of
an
aggravated
21
misdemeanor.
An
aggravated
misdemeanor
is
punishable
by
22
confinement
for
no
more
than
two
years
and
a
fine
of
at
least
23
$855
but
not
more
than
$8,540.
24
In
addition
to
any
other
remedies
available
under
common
25
or
state
law,
failure
to
comply
with
the
requirements
of
the
26
bill
provides
a
basis
for
a
civil
malpractice
action
for
actual
27
and
punitive
damages;
a
basis
for
a
professional
disciplinary
28
action
by
the
appropriate
licensing
board
or
other
entity;
and
29
a
basis
for
recovery
following
a
pregnant
woman’s
death
for
the
30
woman’s
survivors
pursuant
to
a
wrongful
death
action.
A
civil
31
or
criminal
penalty
shall
not
be
assessed
against
a
pregnant
32
woman
upon
whom
a
drug-induced
abortion
is
attempted,
induced,
33
or
performed.
34
The
bill
requires
the
board
of
pharmacy
to
enforce
the
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provisions
of
the
bill
by
specified
means.
1
The
bill
directs
the
board
of
pharmacy
to
develop
a
complaint
2
portal
on
its
internet
site
for
patients,
pharmacies,
health
3
care
providers,
and
the
public
to
submit
information
about
4
potential
violations
of
the
bill
at
no
cost.
5
The
bill
is
not
to
be
construed
as
creating
or
recognizing
6
a
right
to
abortion
or
to
make
lawful
an
abortion
that
is
7
otherwise
unlawful,
and
does
not
repeal,
replace,
or
otherwise
8
invalidate
existing
federal
or
state
laws,
regulations,
or
9
policies.
10
The
bill
provides
that
the
attorney
general
may
bring
an
11
action
to
enforce
compliance
with
the
bill
or
intervene
as
a
12
matter
of
right
in
any
case
in
which
the
constitutionality
of
13
the
bill
is
challenged.
14
The
bill
includes
a
severability
clause.
The
bill
takes
15
effect
upon
enactment.
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