House
Study
Bill
158
-
Introduced
HOUSE
FILE
_____
BY
(PROPOSED
COMMITTEE
ON
HUMAN
RESOURCES
BILL
BY
CHAIRPERSON
MILLER)
A
BILL
FOR
An
Act
relating
to
drug
product
selection.
1
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
2
TLSB
2093HC
(3)
85
pf/nh
H.F.
_____
Section
1.
Section
155A.13A,
Code
2013,
is
amended
to
read
1
as
follows:
2
155A.13A
Nonresident
pharmacy
license
——
required,
renewal,
3
drug
product
selection,
discipline.
4
1.
License
required.
A
pharmacy
located
outside
of
this
5
state
which
delivers,
dispenses,
or
distributes
by
any
method,
6
prescription
drugs
or
devices
to
an
ultimate
user
in
this
state
7
shall
obtain
a
nonresident
pharmacy
license
from
the
board.
8
The
board
shall
make
available
an
application
form
for
a
9
nonresident
pharmacy
license
and
shall
require
such
information
10
it
deems
necessary
to
fulfill
the
purposes
of
this
section
.
A
11
nonresident
pharmacy
shall
do
all
of
the
following
in
order
to
12
obtain
a
nonresident
pharmacy
license
from
the
board:
13
a.
Submit
a
completed
application
form
and
an
application
14
fee
as
determined
by
the
board.
15
b.
Submit
evidence
of
possession
of
a
valid
license,
permit,
16
or
registration
as
a
pharmacy
in
compliance
with
the
laws
of
17
the
state
in
which
it
is
located,
a
copy
of
the
most
recent
18
inspection
report
resulting
from
an
inspection
conducted
by
19
the
regulatory
or
licensing
agency
of
the
state
in
which
it
is
20
located,
and
evidence
of
compliance
with
all
legal
directions
21
and
requests
for
information
issued
by
the
regulatory
or
22
licensing
agency
of
the
state
in
which
it
is
located.
23
c.
Submit
a
list
of
the
names,
titles,
and
locations
of
24
all
principal
owners,
partners,
or
officers
of
the
nonresident
25
pharmacy,
all
pharmacists
employed
by
the
nonresident
pharmacy
26
who
deliver,
dispense,
or
distribute
by
any
method
prescription
27
drugs
to
an
ultimate
user
in
this
state,
and
of
the
pharmacist
28
in
charge
of
the
nonresident
pharmacy.
A
nonresident
pharmacy
29
shall
update
the
list
within
thirty
days
of
any
addition,
30
deletion,
or
other
change
to
the
list.
31
d.
Submit
evidence
that
the
nonresident
pharmacy
maintains
32
records
of
the
controlled
substances
delivered,
dispensed,
or
33
distributed
to
ultimate
users
in
this
state.
34
e.
Submit
evidence
that
the
nonresident
pharmacy
provides,
35
-1-
LSB
2093HC
(3)
85
pf/nh
1/
4
H.F.
_____
during
its
regular
hours
of
operation
for
at
least
six
days
and
1
for
at
least
forty
hours
per
week,
toll-free
telephone
service
2
to
facilitate
communication
between
ultimate
users
in
this
3
state
and
a
pharmacist
who
has
access
to
the
ultimate
user’s
4
records
in
the
nonresident
pharmacy,
and
that
the
toll-free
5
number
is
printed
on
the
label
affixed
to
each
container
of
6
prescription
drugs
delivered,
dispensed,
or
distributed
in
this
7
state.
8
2.
License
renewal.
A
nonresident
pharmacy
shall
renew
its
9
license
on
or
before
January
1
annually.
In
order
to
renew
10
a
nonresident
pharmacy
license,
a
nonresident
pharmacy
shall
11
submit
a
renewal
fee
as
determined
by
the
board,
and
shall
12
fulfill
all
of
the
requirements
of
subsection
1
,
paragraphs
“b”
13
through
“e”
.
A
nonresident
pharmacy
shall
pay
an
additional
fee
14
for
late
renewal
as
determined
by
the
board.
15
3.
Drug
product
selection.
A
nonresident
pharmacy
is
16
subject
to
the
drug
product
selection
requirements
specified
17
in
section
155A.32.
18
3.
4.
Discipline.
The
board
may
deny,
suspend,
or
revoke
a
19
nonresident
pharmacy
license
for
any
violation
of
this
section
,
20
section
155A.15,
subsection
2
,
paragraph
“a”
,
“b”
,
“d”
,
“e”
,
21
“f”
,
“g”
,
“h”
,
or
“i”
,
chapter
124
,
124A
,
124B
,
126
,
or
205
,
or
22
a
rule
of
the
board.
23
Sec.
2.
Section
155A.32,
subsection
2,
Code
2013,
is
amended
24
to
read
as
follows:
25
2.
The
pharmacist
shall
not
exercise
the
drug
product
26
selection
described
in
this
section
if
either
any
of
the
27
following
is
true:
28
a.
The
prescriber
specifically
indicates
that
no
drug
29
product
selection
shall
be
made.
30
b.
The
person
presenting
the
prescription
indicates
that
31
only
the
specific
drug
product
prescribed
should
be
dispensed.
32
However,
this
paragraph
does
not
apply
if
the
cost
of
the
33
prescription
or
any
part
of
it
will
be
paid
by
expenditure
of
34
public
funds
authorized
under
chapter
249A
.
35
-2-
LSB
2093HC
(3)
85
pf/nh
2/
4
H.F.
_____
c.
The
prescriber
indicates
that
a
specific
drug
product
1
should
be
dispensed
and
a
diagnosis
of
epilepsy
is
written
on
2
the
prescription.
For
the
purposes
of
this
paragraph,
“drug
3
product
selection”
includes
dispensing
a
drug
product
of
another
4
manufacturer
instead
of
the
specific
drug
product
the
patient
5
is
currently
prescribed,
and
substituting
a
generic
version
6
for
a
brand
version,
a
brand
version
for
a
generic
version,
7
or
a
generic
version
for
a
generic
version
of
a
different
8
manufacturer.
For
the
purposes
of
this
paragraph,
a
“specific
9
drug
product”
means
a
specific
drug,
strength,
dosage
form,
or
10
dosing
regimen
from
a
specific
manufacturer.
11
Sec.
3.
Section
155A.32,
Code
2013,
is
amended
by
adding
the
12
following
new
subsections:
13
NEW
SUBSECTION
.
4.
If
drug
product
selection
is
prohibited
14
pursuant
to
subsection
2,
paragraph
“c”
,
but
the
specific
15
drug
indicated
is
not
available,
the
pharmacist
may
dispense
16
a
seventy-two-hour
emergency
supply
of
a
bioequivalent
of
17
a
specific
generic
manufacturer’s
product.
If
a
pharmacist
18
dispenses
a
bioequivalent
drug
product
under
this
subsection,
19
the
pharmacist
shall
notify
the
patient
and
the
prescriber
20
of
the
substitution
and
shall
resolve
the
shortage
within
21
seventy-two
hours
of
dispensing
the
substitute
drug
product.
22
The
board
shall
adopt
rules
regarding
notification
of
the
23
patient
and
prescriber
under
this
subsection.
24
NEW
SUBSECTION
.
5.
If
drug
product
selection
is
prohibited
25
under
subsection
2,
paragraph
“c”
,
any
differential
in
cost
to
26
the
pharmacy
or
patient
resulting
from
the
prohibition
shall
be
27
covered
by
the
patient’s
health
carrier
as
defined
in
section
28
514J.102.
29
EXPLANATION
30
This
bill
relates
to
drug
product
selection.
31
The
bill
amends
provisions
relating
to
nonresident
32
pharmacies
to
provide
that
a
nonresident
pharmacy
is
subject
33
to
the
drug
product
selection
requirements
that
are
currently
34
applicable
to
resident
pharmacies.
35
-3-
LSB
2093HC
(3)
85
pf/nh
3/
4
H.F.
_____
The
bill
also
amends
the
list
of
exceptions
to
a
pharmacist
1
exercising
drug
product
selection
to
provide
that
a
pharmacist
2
shall
not
exercise
drug
product
selection
if
the
prescriber
3
indicates
that
a
specific
drug
product
should
be
dispensed
and
4
a
diagnosis
of
epilepsy
is
written
on
the
prescription.
The
5
bill
also
specifies
that
for
the
purposes
of
the
exception,
6
drug
product
selection
includes
dispensing
a
drug
product
of
7
another
manufacturer
instead
of
the
specific
drug
product
the
8
patient
is
currently
prescribed,
and
substituting
a
generic
9
version
for
a
brand
version,
a
brand
version
for
a
generic
10
version,
or
a
generic
version
for
a
generic
version
of
a
11
different
manufacturer.
Additionally,
for
the
purposes
of
12
the
exception,
a
specific
drug
product
means
a
specific
drug,
13
strength,
dosage
form,
or
dosing
regimen
from
a
specific
14
manufacturer.
15
The
bill
also
addresses
substitutions
made
when
a
pharmacy
16
does
not
have
a
specific
drug
product
available
when
drug
17
product
selection
is
prohibited.
In
those
instances,
the
bill
18
provides
that
the
pharmacist
may
dispense
a
72-hour
emergency
19
supply
of
a
bioequivalent
of
a
specific
generic
manufacturer’s
20
product.
If
a
substitute
is
dispensed,
the
pharmacist
is
21
required
to
notify
the
patient
and
the
prescriber
of
the
22
substitution
and
to
resolve
the
shortage
within
72
hours
of
23
dispensing
the
substitute
drug
product.
The
bill
directs
the
24
board
of
pharmacy
to
adopt
rules
regarding
notification
of
the
25
patient
and
prescriber.
26
The
bill
also
provides
that
if
drug
product
selection
27
is
prohibited
relating
to
a
diagnosis
of
epilepsy,
any
28
differential
in
cost
to
the
pharmacy
or
patient
resulting
29
from
the
prohibition
shall
be
covered
by
the
patient’s
health
30
carrier.
31
-4-
LSB
2093HC
(3)
85
pf/nh
4/
4