Bill Text: IA HSB38 | 2017-2018 | 87th General Assembly | Introduced
Bill Title: A bill for an act relating to the prescribing of biological products and making penalties applicable.
Spectrum: Committee Bill
Status: (N/A - Dead) 2017-02-09 - Committee report, recommending amendment and passage. H.J. 264. [HSB38 Detail]
Download: Iowa-2017-HSB38-Introduced.html
House
Study
Bill
38
-
Introduced
HOUSE
FILE
_____
BY
(PROPOSED
COMMITTEE
ON
HUMAN
RESOURCES
BILL
BY
CHAIRPERSON
FRY)
A
BILL
FOR
An
Act
relating
to
the
prescribing
of
biological
products
and
1
making
penalties
applicable.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
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Section
1.
Section
155A.3,
Code
2017,
is
amended
by
adding
1
the
following
new
subsections:
2
NEW
SUBSECTION
.
2A.
“Biological
product”
means
the
same
as
3
defined
in
42
U.S.C.
§262.
4
NEW
SUBSECTION
.
19A.
“Interchangeable
biological
product”
5
means
either
of
the
following:
6
a.
A
biological
product
that
the
United
States
food
and
7
drug
administration
has
licensed
and
has
determined
meets
8
the
standards
for
interchangeability
pursuant
to
42
U.S.C.
9
§262(k)(4).
10
b.
A
biological
product
that
the
United
States
food
and
11
drug
administration
has
determined
to
be
therapeutically
12
equivalent
to
another
biological
product
as
set
forth
in
the
13
latest
edition
or
supplement
of
the
United
States
food
and
14
drug
administration
approved
drug
products
with
therapeutic
15
equivalence
evaluations
publication.
16
Sec.
2.
Section
155A.28,
Code
2017,
is
amended
to
read
as
17
follows:
18
155A.28
Label
of
prescription
drugs
——
interchangeable
19
biological
product
list
.
20
1.
The
label
of
any
drug
,
biological
product,
or
device
sold
21
and
dispensed
on
the
prescription
of
a
practitioner
shall
be
in
22
compliance
with
rules
adopted
by
the
board.
23
2.
The
board
shall
maintain
a
link
on
its
internet
site
to
24
the
current
list
of
all
biological
products
that
the
United
25
States
food
and
drug
administration
has
determined
to
be
26
interchangeable
biological
products.
27
Sec.
3.
Section
155A.32,
Code
2017,
is
amended
to
read
as
28
follows:
29
155A.32
Drug
product
selection
——
restrictions.
30
1.
a.
If
an
authorized
prescriber
prescribes,
in
31
writing,
electronically,
by
facsimile,
or
orally,
a
drug
32
by
its
brand
or
trade
name,
the
pharmacist
may
exercise
33
professional
judgment
in
the
economic
interest
of
the
patient
34
by
selecting
a
drug
product
with
the
same
generic
name
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and
demonstrated
bioavailability
as
the
one
drug
product
1
prescribed
for
dispensing
and
sale
to
the
patient.
If
the
2
cost
of
the
prescription
or
any
part
of
it
will
be
paid
by
3
expenditure
of
public
funds
authorized
under
chapter
249A
,
the
4
pharmacist
shall
exercise
professional
judgment
by
selecting
5
a
drug
product
with
the
same
generic
name
and
demonstrated
6
bioavailability
as
the
one
drug
product
prescribed
for
7
dispensing
and
sale.
If
the
pharmacist
exercises
drug
product
8
selection,
the
pharmacist
shall
inform
the
patient
of
the
9
savings
which
the
patient
will
obtain
as
a
result
of
the
drug
10
product
selection
and
pass
on
to
the
patient
no
less
than
fifty
11
percent
of
the
difference
in
actual
acquisition
costs
between
12
the
drug
prescribed
and
the
drug
substituted.
13
b.
If
an
authorized
prescriber
prescribes
a
biological
14
product,
the
pharmacist
may
exercise
professional
judgment
in
15
the
economic
interest
of
the
patient
by
selecting
a
biological
16
product
that
is
an
interchangeable
biological
product
for
the
17
biological
product
prescribed
for
dispensing
and
sale
to
the
18
patient.
If
the
cost
of
the
prescription
or
any
part
of
it
will
19
be
paid
by
expenditure
of
public
funds
authorized
under
chapter
20
249A,
the
pharmacist
shall
exercise
professional
judgment
by
21
selecting
a
biological
product
that
is
an
interchangeable
22
biological
product
for
the
biological
product
prescribed
for
23
dispensing
and
sale.
If
the
pharmacist
exercises
biological
24
product
selection,
the
pharmacist
shall
inform
the
patient
of
25
the
savings
which
the
patient
will
obtain
as
a
result
of
the
26
biological
product
selection
and
pass
on
to
the
patient
no
less
27
than
fifty
percent
of
the
difference
in
actual
acquisition
28
costs
between
the
biological
product
prescribed
and
the
29
interchangeable
biological
product
substituted.
30
2.
The
pharmacist
shall
not
exercise
the
drug
or
biological
31
product
selection
described
in
this
section
if
either
any
of
32
the
following
is
true:
33
a.
The
prescriber
specifically
indicates
that
no
drug
or
34
biological
product
selection
shall
be
made.
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b.
The
person
presenting
the
prescription
indicates
that
1
only
the
specific
drug
product
prescribed
should
be
dispensed.
2
However
Except
for
biological
products
,
this
paragraph
does
not
3
apply
if
the
cost
of
the
prescription
or
any
part
of
it
will
be
4
paid
by
expenditure
of
public
funds
authorized
under
chapter
5
249A
.
6
3.
If
selection
of
a
generically
equivalent
drug
product
7
or
an
interchangeable
biological
product
is
made
under
this
8
section
,
the
pharmacist
making
the
selection
shall
note
that
9
fact
and
the
name
of
the
manufacturer
of
the
selected
drug
on
10
the
prescription
presented
by
the
patient
or
the
patient’s
11
adult
representative
or
transmitted
by
the
prescriber
or
the
12
prescriber’s
authorized
agent.
13
4.
a.
Within
five
business
days
following
the
dispensing
14
of
a
biological
product,
the
dispensing
pharmacist
or
the
15
pharmacist’s
designee
shall
make
an
entry
of
the
specific
16
biological
product
provided
to
the
patient,
including
the
name
17
of
the
biological
product
and
the
manufacturer.
The
entry
18
shall
be
electronically
accessible
to
the
prescriber
through
19
one
of
the
following
means:
20
(1)
An
interoperable
electronic
medical
records
system.
21
(2)
An
electronic
prescribing
technology.
22
(3)
A
pharmacy
benefit
management
system.
23
(4)
A
pharmacy
record.
24
b.
An
entry
into
an
electronic
records
system
as
described
25
in
this
subsection
is
presumed
to
provide
notice
to
the
26
prescriber.
If
the
entry
is
not
made
electronically,
the
27
pharmacist
shall
communicate
the
name
and
manufacturer
of
the
28
biological
product
dispensed
to
the
prescriber
using
facsimile,
29
telephone,
electronic
transmission,
or
other
prevailing
means.
30
c.
Communication
under
this
subsection
shall
not
be
required
31
in
either
of
the
following
circumstances:
32
(1)
There
is
no
federal
food
and
drug
33
administration-approved
interchangeable
biological
product
for
34
the
product
prescribed.
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(2)
A
refill
prescription
is
not
changed
from
the
product
1
dispensed
on
the
prior
filling
of
the
prescription.
2
EXPLANATION
3
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
4
the
explanation’s
substance
by
the
members
of
the
general
assembly.
5
This
bill
adopts
by
reference
to
federal
law
a
definition
of
6
“biological
product”
and
defines
“interchangeable
biological
7
product”.
As
described
by
the
United
States
food
and
drug
8
administration,
a
“biological
product”
is
a
medical
product,
9
often
made
from
a
variety
of
natural
sources,
used
for
a
broad
10
range
of
diseases
or
conditions,
particularly
chronic,
serious,
11
or
life-threatening
conditions
such
as
cancer
and
rheumatoid
12
arthritis.
13
The
bill
provides
that
pharmacists
may
use
professional
14
judgment
to
distribute
an
interchangeable
biological
product
15
when
an
authorized
prescriber
prescribes
a
biological
product.
16
The
bill
requires
the
board
of
pharmacy
to
maintain
a
link
17
on
its
internet
site
to
the
current
list
of
all
biological
18
products
that
the
United
States
food
and
drug
administration
19
has
determined
to
be
interchangeable
biological
products.
20
The
bill
provides
that
a
pharmacist
may
not
dispense
21
an
interchangeable
biological
product
if
the
prescriber
22
specifically
indicates
that
no
product
selection
shall
be
made
23
or
the
person
presenting
the
prescription
indicates
that
only
24
the
specific
biological
product
prescribed
should
be
dispensed.
25
The
bill
requires
that
within
five
days
of
dispensing
an
26
interchangeable
biological
product,
a
pharmacist
must
make
27
an
entry
into
one
of
a
specified
type
of
electronic
records
28
systems
noting
the
name
and
manufacturer
of
the
biological
29
product.
According
to
the
bill,
such
an
entry
is
deemed
to
30
provide
notice
to
the
prescriber
if
done
electronically.
If
31
it
is
not
done
electronically,
the
pharmacist
must
otherwise
32
provide
the
name
and
manufacturer
of
the
biological
product
to
33
the
prescriber.
Such
communication
is
not
required
if
a
refill
34
prescription
is
not
changed
from
the
product
dispensed
on
the
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prior
filling
of
the
prescription.
1
A
person
who
violates
these
provisions
with
regard
to
2
a
noncontrolled
substance
shall
be
guilty
of
a
serious
3
misdemeanor
for
a
first
violation,
an
aggravated
misdemeanor
4
for
a
second
offense
or
if
the
person
has
been
convicted
with
5
a
violation
of
laws
relating
to
prescription
drugs
or
devices
6
in
other
jurisdictions,
or
a
class
“D”
felony
for
a
third
7
offense
or
a
second
offense
with
prior
conviction
in
another
8
jurisdiction.
A
person
who
violates
these
provisions
with
9
regard
to
a
controlled
substance
shall
be
punished
pursuant
to
10
Code
section
124.401,
subsection
1,
and
other
provisions
of
11
Code
chapter
124,
division
IV.
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