House
File
305
-
Enrolled
House
File
305
AN
ACT
RELATING
TO
THE
PRESCRIBING
OF
BIOLOGICAL
PRODUCTS
AND
MAKING
PENALTIES
APPLICABLE.
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
Section
1.
Section
155A.3,
Code
2017,
is
amended
by
adding
the
following
new
subsections:
NEW
SUBSECTION
.
2A.
“Biological
product”
means
the
same
as
defined
in
42
U.S.C.
§262.
NEW
SUBSECTION
.
19A.
“Interchangeable
biological
product”
means
either
of
the
following:
a.
A
biological
product
that
the
United
States
food
and
drug
administration
has
licensed
and
has
determined
meets
the
standards
for
interchangeability
pursuant
to
42
U.S.C.
§262(k)(4).
b.
A
biological
product
that
the
United
States
food
and
drug
administration
has
determined
to
be
therapeutically
equivalent
to
another
biological
product
as
set
forth
in
the
latest
edition
or
supplement
of
the
United
States
food
and
drug
administration
approved
drug
products
with
therapeutic
equivalence
evaluations
publication.
House
File
305,
p.
2
Sec.
2.
Section
155A.28,
Code
2017,
is
amended
to
read
as
follows:
155A.28
Label
of
prescription
drugs
——
interchangeable
biological
product
list
.
1.
The
label
of
any
drug
,
biological
product,
or
device
sold
and
dispensed
on
the
prescription
of
a
practitioner
shall
be
in
compliance
with
rules
adopted
by
the
board.
2.
The
board
shall
maintain
a
link
on
its
internet
site
to
the
current
list
of
all
biological
products
that
the
United
States
food
and
drug
administration
has
determined
to
be
interchangeable
biological
products.
Sec.
3.
Section
155A.32,
Code
2017,
is
amended
to
read
as
follows:
155A.32
Drug
product
selection
——
restrictions.
1.
a.
If
an
authorized
prescriber
prescribes,
in
writing,
electronically,
by
facsimile,
or
orally,
a
drug
by
its
brand
or
trade
name,
the
pharmacist
may
exercise
professional
judgment
in
the
economic
interest
of
the
patient
by
selecting
a
drug
product
with
the
same
generic
name
and
demonstrated
bioavailability
as
the
one
drug
product
prescribed
for
dispensing
and
sale
to
the
patient.
If
the
cost
of
the
prescription
or
any
part
of
it
will
be
paid
by
expenditure
of
public
funds
authorized
under
chapter
249A
,
the
pharmacist
shall
exercise
professional
judgment
by
selecting
a
drug
product
with
the
same
generic
name
and
demonstrated
bioavailability
as
the
one
drug
product
prescribed
for
dispensing
and
sale.
If
the
pharmacist
exercises
drug
product
selection,
the
pharmacist
shall
inform
the
patient
of
the
savings
which
the
patient
will
obtain
as
a
result
of
the
drug
product
selection
and
pass
on
to
the
patient
no
less
than
fifty
percent
of
the
difference
in
actual
acquisition
costs
between
the
drug
prescribed
and
the
drug
substituted.
b.
If
an
authorized
prescriber
prescribes
a
biological
product,
the
pharmacist
may
exercise
professional
judgment
in
the
economic
interest
of
the
patient
by
selecting
a
biological
product
that
is
an
interchangeable
biological
product
for
the
biological
product
prescribed
for
dispensing
and
sale
to
the
patient.
If
the
cost
of
the
prescription
or
any
part
of
it
will
be
paid
by
expenditure
of
public
funds
House
File
305,
p.
3
authorized
under
chapter
249A,
the
pharmacist
shall
exercise
professional
judgment
by
selecting
a
biological
product
that
is
an
interchangeable
biological
product
for
the
biological
product
prescribed
for
dispensing
and
sale.
2.
The
pharmacist
shall
not
exercise
the
drug
or
biological
product
selection
described
in
this
section
if
either
any
of
the
following
is
true:
a.
The
prescriber
specifically
indicates
that
no
drug
or
biological
product
selection
shall
be
made.
b.
The
person
presenting
the
prescription
indicates
that
only
the
specific
drug
product
prescribed
should
be
dispensed.
However,
this
paragraph
does
not
apply
if
the
cost
of
the
prescription
or
any
part
of
it
will
be
paid
by
expenditure
of
public
funds
authorized
under
chapter
249A
.
3.
If
selection
of
a
generically
equivalent
drug
product
or
an
interchangeable
biological
product
is
made
under
this
section
,
the
pharmacist
making
the
selection
shall
inform
the
patient
and
note
that
fact
and
the
name
of
the
manufacturer
of
the
selected
drug
on
the
prescription
presented
by
the
patient
or
the
patient’s
adult
representative
or
transmitted
by
the
prescriber
or
the
prescriber’s
authorized
agent.
4.
a.
Within
five
business
days
following
the
dispensing
of
a
biological
product,
the
dispensing
pharmacist
or
the
pharmacist’s
designee
shall
make
an
entry
of
the
specific
biological
product
provided
to
the
patient,
including
the
name
of
the
biological
product
and
the
manufacturer.
The
entry
shall
be
electronically
accessible
to
the
prescriber
through
one
of
the
following
means:
(1)
An
interoperable
electronic
medical
records
system.
(2)
An
electronic
prescribing
technology.
(3)
A
pharmacy
benefit
management
system.
(4)
A
pharmacy
record.
b.
An
entry
into
an
electronic
records
system
as
described
in
this
subsection
is
presumed
to
provide
notice
to
the
prescriber.
If
the
entry
is
not
made
electronically,
the
pharmacist
shall
communicate
the
name
and
manufacturer
of
the
biological
product
dispensed
to
the
prescriber
using
facsimile,
telephone,
electronic
transmission,
or
other
prevailing
means.
House
File
305,
p.
4
c.
Communication
under
this
subsection
shall
not
be
required
in
either
of
the
following
circumstances:
(1)
There
is
no
federal
food
and
drug
administration-approved
interchangeable
biological
product
for
the
product
prescribed.
(2)
A
refill
prescription
is
not
changed
from
the
product
dispensed
on
the
prior
filling
of
the
prescription.
______________________________
LINDA
UPMEYER
Speaker
of
the
House
______________________________
JACK
WHITVER
President
of
the
Senate
I
hereby
certify
that
this
bill
originated
in
the
House
and
is
known
as
House
File
305,
Eighty-seventh
General
Assembly.
______________________________
CARMINE
BOAL
Chief
Clerk
of
the
House
Approved
_______________,
2017
______________________________
TERRY
E.
BRANSTAD
Governor