House
Study
Bill
533
-
Introduced
SENATE/HOUSE
FILE
_____
BY
(PROPOSED
BOARD
OF
PHARMACY
BILL)
A
BILL
FOR
An
Act
relating
to
the
practice
of
pharmacy,
and
providing
for
1
a
repeal.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
TLSB
5383DP
(8)
88
pf/rh
S.F.
_____
H.F.
_____
DIVISION
I
1
PHARMACY
TECHNICIAN
REGISTRATION
2
Section
1.
Section
147.107,
subsection
2,
paragraph
d,
Code
3
2020,
is
amended
to
read
as
follows:
4
d.
A
pharmacist
who
dispenses
prescription
drugs,
including
5
but
not
limited
to
controlled
substances,
for
human
use,
6
may
delegate
nonjudgmental
dispensing
functions
only
when
7
verification
of
the
accuracy
and
completeness
of
the
dispensing
8
is
determined
by
the
pharmacist
in
the
pharmacist’s
physical
9
presence.
The
pharmacist’s
verification
of
the
accuracy
of
the
10
prescription
drug
dispensed
shall
not
be
required
when
verified
11
by
a
certified
pharmacy
technician
in
a
technician
product
12
verification
program
or
a
tech-check-tech
program
as
defined
13
in
section
155A.3
.
The
pharmacist’s
physical
presence
shall
14
not
be
required
when
the
pharmacist
is
remotely
supervising
15
pharmacy
personnel
operating
in
an
approved
a
licensed
16
telepharmacy
site
or
when
utilizing
an
automated
dispensing
17
system
that
utilizes
an
internal
quality
control
assurance
18
plan.
When
utilizing
a
technician
product
verification
program
19
or
tech-check-tech
program
,
or
when
remotely
supervising
20
pharmacy
personnel
operating
at
an
approved
a
licensed
21
telepharmacy
site,
the
pharmacist
shall
utilize
an
internal
22
quality
control
assurance
plan,
in
accordance
with
rules
23
adopted
by
the
board
of
pharmacy,
that
ensures
accuracy
for
24
dispensing.
Automated
dispensing
verification,
technician
25
product
verification,
and
telepharmacy
practice
accuracy
and
26
completeness
remains
the
responsibility
of
the
pharmacist
and
27
shall
be
determined
in
accordance
with
rules
adopted
by
the
28
board
of
pharmacy.
29
Sec.
2.
Section
155A.3,
subsection
46,
Code
2020,
is
amended
30
by
striking
the
subsection.
31
Sec.
3.
Section
155A.6A,
subsections
3
and
4,
Code
2020,
are
32
amended
to
read
as
follows:
33
3.
A
person
who
is
in
the
process
of
acquiring
national
34
certification
as
a
pharmacy
technician
and
who
is
in
training
35
-1-
LSB
5383DP
(8)
88
pf/rh
1/
10
S.F.
_____
H.F.
_____
to
become
a
pharmacy
technician
shall
register
with
the
board
1
as
a
pharmacy
technician.
The
registration
shall
be
issued
for
2
a
period
not
to
exceed
one
year
and
shall
not
be
renewable.
3
4.
The
board
shall
adopt
rules
in
accordance
with
4
chapter
17A
on
matters
pertaining
to
pharmacy
technician
5
registration,
application,
forms,
renewals,
fees,
termination
6
of
registration,
tech-check-tech
programs,
technician
product
7
verification
programs,
national
certification,
training,
and
8
any
other
relevant
matters.
9
Sec.
4.
Section
155A.33,
Code
2020,
is
amended
to
read
as
10
follows:
11
155A.33
Delegation
of
technical
functions.
12
A
pharmacist
may
delegate
technical
dispensing
functions
13
to
pharmacy
technicians,
but
only
if
the
pharmacist
is
14
physically
present
to
verify
the
accuracy
and
completeness
15
of
the
patient’s
prescription
prior
to
the
delivery
of
the
16
prescription
to
the
patient
or
the
patient’s
representative.
17
However,
the
physical
presence
requirement
does
not
apply
when
18
a
pharmacist
is
utilizing
an
automated
dispensing
system
or
a
19
technician
product
verification
program
or
when
a
pharmacist
is
20
remotely
supervising
a
certified
pharmacy
technician
practicing
21
at
a
licensed
telepharmacy
site
approved
by
the
board
.
When
22
using
an
automated
dispensing
system
or
a
technician
product
23
verification
program,
or
when
remotely
supervising
a
certified
24
pharmacy
technician
practicing
at
an
approved
a
licensed
25
telepharmacy
site,
the
pharmacist
shall
utilize
an
internal
26
quality
control
assurance
plan
that
ensures
accuracy
for
27
dispensing.
Verification
of
automated
dispensing,
technician
28
product
verification,
and
telepharmacy
practice
accuracy
and
29
completeness
remains
the
responsibility
of
the
pharmacist
and
30
shall
be
determined
in
accordance
with
rules
adopted
by
the
31
board.
32
DIVISION
II
33
TELEPHARMACY
PRACTICE
34
Sec.
5.
Section
155A.13,
subsection
3,
Code
2020,
is
amended
35
-2-
LSB
5383DP
(8)
88
pf/rh
2/
10
S.F.
_____
H.F.
_____
by
adding
the
following
new
paragraph:
1
NEW
PARAGRAPH
.
f.
The
board
may
adopt
rules
authorizing
a
2
pharmacist
or
a
certified
pharmacy
technician
to
supervise
a
3
pharmacy
support
person
registered
pursuant
to
section
155A.6B
4
and
working
at
a
licensed
telepharmacy
site.
5
DIVISION
III
6
OUTSOURCING
FACILITY
LICENSE
7
Sec.
6.
Section
155A.13C,
subsection
1,
Code
2020,
is
8
amended
by
adding
the
following
new
paragraph:
9
NEW
PARAGRAPH
.
e.
Submit
evidence
of
a
satisfactory
10
inspection
conducted
by
the
home
state
regulatory
authority
11
or
an
entity
approved
by
the
board
in
the
two-year
period
12
immediately
preceding
the
application
which
demonstrates
13
compliance
with
current
good
manufacturing
practices.
In
14
addition,
the
applicant
shall
submit
evidence
of
correction
of
15
all
deficiencies
discovered
in
such
inspections
and
evidence
of
16
compliance
with
all
directives
from
the
home
state
regulatory
17
authority
or
entity
approved
by
the
board.
The
board
may
18
recover
from
an
outsourcing
facility,
prior
to
the
issuance
19
of
a
license
or
license
renewal,
the
costs
associated
with
20
conducting
an
inspection
by
or
on
behalf
of
the
board
for
21
purposes
of
satisfying
the
requirements
of
this
paragraph.
22
DIVISION
IV
23
PRESCRIPTION
ADAPTATION
24
Sec.
7.
Section
155A.27,
Code
2020,
is
amended
by
adding
the
25
following
new
subsection:
26
NEW
SUBSECTION
.
8.
A
pharmacist,
in
exercising
the
27
pharmacist’s
professional
judgment
and
acting
in
good
faith
to
28
meet
the
intent
of
the
prescriber,
may
adapt
a
prescription
for
29
a
substance
that
is
not
a
controlled
substance
in
compliance
30
with
this
subsection.
A
pharmacist
who
adapts
a
prescription
31
in
compliance
with
this
subsection
shall
document
the
32
adaptation
in
the
patient’s
record
and
notify
the
prescriber
33
of
the
adaptation.
34
a.
No
adaptation
without
prior
consent.
A
pharmacist
shall
35
-3-
LSB
5383DP
(8)
88
pf/rh
3/
10
S.F.
_____
H.F.
_____
not
adapt
a
prescription
pursuant
to
this
subsection
without
1
prior
consent
of
the
prescriber
if
the
prescriber
has
indicated
2
“no
adaptation”
on
the
prescription.
3
b.
Quantity
adaptation.
A
pharmacist
may
change
the
4
quantity
of
the
drug
prescribed
when
deemed
appropriate
in
5
the
professional
judgment
of
the
pharmacist
including
but
not
6
limited
to
in
any
of
the
following
situations:
7
(1)
The
prescribed
quantity
or
package
size
is
not
8
commercially
available.
9
(2)
The
change
in
quantity
is
related
to
a
change
in
dosage
10
form.
11
(3)
The
change
in
quantity
is
made
to
ensure
the
completion
12
of
the
prescriber’s
intended
duration
of
treatment.
13
(4)
The
change
in
quantity
is
made
to
extend
a
maintenance
14
drug
for
the
limited
quantity
necessary
to
coordinate
a
15
patient’s
refills
in
a
medication
synchronization
program.
16
c.
Dosage
form
adaptation.
A
pharmacist
may
change
17
the
dosage
form
of
the
drug
prescribed
if
it
is
in
the
18
best
interest
of
patient
care,
as
long
as
the
prescriber’s
19
directions
are
also
modified
to
equate
to
an
equivalent
amount
20
of
drug
dispensed
as
prescribed.
21
d.
Completion
of
missing
information.
A
pharmacist
may
22
complete
missing
information
on
a
prescription
pursuant
to
23
this
subsection
if
there
is
sufficient
evidence
to
support
the
24
change.
25
e.
Payment
recoupment.
A
health
benefit
plan,
as
defined
26
in
section
514J.102,
a
health
carrier,
as
defined
in
section
27
514J.102,
and
a
pharmacy
benefits
manager,
as
defined
in
28
section
510B.1,
shall
not
recoup
payment
from
a
pharmacy
29
following
an
audit
on
an
otherwise
valid
prescription
based
30
solely
on
a
pharmacist’s
adaptation
of
a
prescription
pursuant
31
to
this
subsection.
32
DIVISION
V
33
EMERGENCY
DISPENSING
34
Sec.
8.
Section
155A.29,
Code
2020,
is
amended
to
read
as
35
-4-
LSB
5383DP
(8)
88
pf/rh
4/
10
S.F.
_____
H.F.
_____
follows:
1
155A.29
Prescription
refills.
2
1.
Except
as
specified
in
subsection
2
or
3
,
a
prescription
3
for
any
prescription
drug
or
device
which
is
not
a
controlled
4
substance
shall
not
be
filled
or
refilled
more
than
eighteen
5
months
after
the
date
on
which
the
prescription
was
issued
and
6
a
prescription
which
is
authorized
to
be
refilled
shall
not
be
7
refilled
more
than
twelve
times.
8
2.
A
pharmacist
may
exercise
professional
judgment
by
9
refilling
a
prescription
without
prescriber
authorization
if
10
all
of
the
following
are
true:
11
a.
The
pharmacist
is
unable
to
contact
the
prescriber
after
12
reasonable
effort
efforts
.
13
b.
Failure
to
refill
the
prescription
might
result
in
14
an
interruption
of
therapeutic
regimen
or
create
patient
15
suffering.
16
c.
The
pharmacist
informs
the
patient
or
the
patient’s
17
representative
at
the
time
of
dispensing,
and
the
practitioner
18
at
the
earliest
convenience
that
prescriber
reauthorization
is
19
required.
20
3.
d.
Prescriptions
may
be
refilled
once
pursuant
to
this
21
subsection
2
for
a
period
of
time
reasonably
necessary
for
the
22
pharmacist
to
secure
prescriber
authorization.
23
3.
a.
In
addition
to
the
authorization
for
a
pharmacist
to
24
refill
a
prescription
without
prescriber
authorization
pursuant
25
to
subsection
2,
a
pharmacist
may
exercise
professional
26
judgment
and
refill
a
prescription
for
a
chronic
maintenance
27
drug
without
prescriber
authorization
if
all
of
the
following
28
are
applicable:
29
(1)
The
pharmacist
is
unable,
after
reasonable
efforts,
to
30
obtain
authorization
from
the
prescriber
or
another
health
care
31
provider
responsible
for
the
patient’s
care.
32
(2)
In
the
pharmacist’s
professional
judgment,
the
refusal
33
to
dispense
the
refill
of
the
chronic
maintenance
drug
will
34
endanger
the
patient’s
life
or
health
or
will
disrupt
an
35
-5-
LSB
5383DP
(8)
88
pf/rh
5/
10
S.F.
_____
H.F.
_____
essential
drug
therapy
for
a
chronic
condition
of
the
patient.
1
b.
The
pharmacist
may
dispense
an
amount
of
the
chronic
2
maintenance
drug
not
to
exceed
the
amount
of
the
most
recent
3
prescription
or
the
standard
quantity
of
the
drug
dispensed.
4
c.
The
pharmacist
shall
dispense
the
chronic
maintenance
5
drug
refill
in
accordance
with
standard
procedures
and
6
documentation
requirements
adopted
by
rule
of
the
board.
7
d.
For
the
purposes
of
this
subsection,
“chronic
maintenance
8
drug”
means
a
drug,
other
than
a
controlled
substance,
that
is
9
prescribed
to
a
patient
to
be
taken
on
a
recurring
basis,
and
10
is
used
as
a
life
saving
rescue
drug
for
a
chronic
condition
or
11
is
essential
to
the
continuation
of
drug
therapy
for
a
chronic
12
condition.
13
4.
An
authorization
to
refill
a
prescription
drug
order
14
shall
be
transmitted
to
a
pharmacy
by
a
prescriber
or
the
15
prescriber’s
authorized
agent
pursuant
to
section
155A.27
,
16
except
that
prescription
drug
orders
for
controlled
substances
17
shall
be
transmitted
pursuant
to
section
124.308
,
and,
if
not
18
transmitted
directly
by
the
practitioner,
shall
also
include
19
the
name
and
title
of
the
practitioner’s
agent
completing
the
20
transmission.
21
DIVISION
VI
22
IMMUNIZATIONS
23
Sec.
9.
Section
155A.46,
subsection
1,
paragraph
d,
Code
24
2020,
is
amended
to
read
as
follows:
25
d.
Prior
to
the
ordering
and
administration
of
a
vaccination
26
non-influenza
vaccine
or
immunization
authorized
by
this
27
subsection
,
pursuant
to
statewide
protocols,
a
licensed
28
pharmacist
shall
consult
and
review
the
statewide
immunization
29
registry
or
health
information
network.
The
board
shall
30
adopt
rules
requiring
the
reporting
of
the
administration
of
31
vaccines
and
immunizations
authorized
by
this
subsection
to
32
a
patient’s
primary
health
care
provider,
primary
physician,
33
and
a
statewide
immunization
registry
or
health
information
34
network.
A
licensed
pharmacist
shall
not
be
required
to
report
35
-6-
LSB
5383DP
(8)
88
pf/rh
6/
10
S.F.
_____
H.F.
_____
to
a
statewide
immunization
registry
or
health
information
1
network
the
administration
of
an
influenza
vaccine
administered
2
to
patients
ages
eighteen
and
older.
3
DIVISION
VII
4
COLLABORATIVE
PHARMACY
PRACTICE
5
Sec.
10.
Section
124.101,
Code
2020,
is
amended
by
adding
6
the
following
new
subsections:
7
NEW
SUBSECTION
.
4A.
“Collaborative
pharmacy
practice”
means
8
the
same
as
defined
in
section
155A.3.
9
NEW
SUBSECTION
.
4B.
“Collaborative
pharmacy
practice
10
agreement”
means
the
same
as
defined
in
section
155A.3.
11
Sec.
11.
Section
124.308,
subsection
2,
paragraph
c,
12
subparagraph
(7),
Code
2020,
is
amended
to
read
as
follows:
13
(7)
A
prescription
issued
pursuant
to
an
established
and
14
valid
collaborative
pharmacy
practice
agreement,
standing
15
order,
or
drug
research
protocol.
16
Sec.
12.
NEW
SECTION
.
124.308A
Collaborative
pharmacy
17
practice.
18
Notwithstanding
any
provision
to
the
contrary,
a
pharmacist
19
may
engage
in
a
collaborative
pharmacy
practice
under
a
20
collaborative
pharmacy
practice
agreement
to
provide
patient
21
care
and
drug
therapy
management
services
to
a
patient.
22
Sec.
13.
Section
155A.3,
Code
2020,
is
amended
by
adding
the
23
following
new
subsections:
24
NEW
SUBSECTION
.
5A.
“Collaborative
pharmacy
practice”
means
25
a
practice
of
pharmacy
whereby
a
pharmacist
provides
patient
26
care
and
drug
therapy
management
services,
not
otherwise
27
permitted
to
be
performed
by
a
pharmacist,
to
patients
under
a
28
collaborative
pharmacy
practice
agreement.
29
NEW
SUBSECTION
.
5B.
“Collaborative
pharmacy
practice
30
agreement”
means
a
written
agreement
between
one
or
more
31
pharmacists
and
one
or
more
physicians,
advanced
registered
32
nurse
practitioners,
advanced
practice
registered
nurses,
or
33
dentists
that
provides
for
a
collaborative
pharmacy
practice
34
and
defines
the
nature,
scope,
conditions,
and
limitations
of
35
-7-
LSB
5383DP
(8)
88
pf/rh
7/
10
S.F.
_____
H.F.
_____
the
patient
care
and
drug
therapy
management
services
to
be
1
provided
by
the
pharmacist
or
pharmacists.
2
Sec.
14.
Section
155A.27,
subsection
2,
paragraph
b,
3
subparagraph
(10),
Code
2020,
is
amended
to
read
as
follows:
4
(10)
A
prescription
issued
pursuant
to
an
established
and
5
valid
collaborative
pharmacy
practice
agreement,
standing
6
order,
or
drug
research
protocol.
7
Sec.
15.
NEW
SECTION
.
155A.47
Collaborative
pharmacy
8
practice.
9
Notwithstanding
any
provision
to
the
contrary,
a
pharmacist
10
may
engage
in
a
collaborative
pharmacy
practice
under
a
11
collaborative
pharmacy
practice
agreement
to
provide
patient
12
care
and
drug
therapy
management
services
to
a
patient.
13
DIVISION
VIII
14
PHARMACY
PILOT
OR
DEMONSTRATION
RESEARCH
PROJECTS
15
Sec.
16.
NEW
SECTION
.
155A.48
Pilot
or
demonstration
16
research
projects.
17
1.
Notwithstanding
any
provision
of
section
147.107,
18
subsection
2,
or
section
155A.33
to
the
contrary,
the
board
may
19
approve
a
pilot
or
demonstration
research
project
of
innovative
20
applications
in
the
practice
of
pharmacy
to
provide
enhanced
21
patient
care.
22
2.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
for
23
application
for
and
approval
of
such
projects.
The
rules
may
24
include
exceptions
to
any
existing
rules
under
the
purview
25
of
the
board
as
necessary
for
completion
of
the
project,
26
limited
to
the
duration
of
the
project.
The
board
may
approve
27
a
project
for
no
more
than
eighteen
months.
The
board
may
28
extend
or
renew
a
project
in
accordance
with
board
rules.
All
29
projects
shall
comply
with
the
rules
adopted
for
such
projects.
30
3.
The
board
shall
not
approve
any
project
that
expands
the
31
practice
of
pharmacy
as
defined
in
section
155A.3.
32
Sec.
17.
REPEAL.
2011
Iowa
Acts,
chapter
63,
section
36,
33
is
repealed.
34
EXPLANATION
35
-8-
LSB
5383DP
(8)
88
pf/rh
8/
10
S.F.
_____
H.F.
_____
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
1
the
explanation’s
substance
by
the
members
of
the
general
assembly.
2
This
bill
relates
to
pharmacy
practice.
3
Division
I
of
the
bill
eliminates
the
tech-check-tech
4
program.
The
board
of
pharmacy
(board)
adopted
administrative
5
rules
to
implement
and
establish
a
technician
product
6
verification
program
as
authorized
by
2018
Iowa
Acts,
chapter
7
1142,
enacting
Code
section
155A.33A.
Division
I
also
8
eliminates
the
one-year
registration
limitation
for
a
person
in
9
training
to
become
a
pharmacy
technician
and
makes
conforming
10
terminology
changes.
11
Division
II
of
the
bill
authorizes
the
board
to
adopt
rules
12
to
authorize
a
pharmacist
or
a
certified
pharmacy
technician
13
to
supervise
a
pharmacy
support
person
working
at
a
licensed
14
telepharmacy
site.
15
Division
III
of
the
bill
requires
a
drug
compounding
16
outsourcing
facility
seeking
licensure
in
the
state
to
17
have
been
inspected
by
the
facility’s
home
state
regulatory
18
authority
or
other
entity
approved
by
the
board
in
the
two-year
19
period
immediately
preceding
the
application,
which
inspection
20
demonstrates
compliance
with
federal
current
good
manufacturing
21
practices.
The
bill
also
allows
the
board
to
recover
costs
22
associated
with
conducting
an
inspection
to
satisfy
the
23
inspection
requirement.
24
Division
IV
of
the
bill
authorizes
a
pharmacist
to
make
25
certain
adaptations
to
prescriptions
for
substances
that
are
26
not
controlled
substances
when
appropriate
to
fulfill
the
27
prescriber’s
intent
of
the
prescription
medication
therapy.
28
Any
adaptation
made
must
be
documented
in
the
patient’s
record
29
and
the
prescriber
must
be
notified
of
the
adaptation
of
the
30
prescription.
The
bill
prohibits
a
third-party
payer
from
31
recouping
payment
for
the
prescription
as
a
result
of
an
32
audit
of
an
otherwise
valid
prescription
based
solely
on
the
33
pharmacist’s
adaptation
of
the
prescription.
34
Division
V
authorizes
a
pharmacist
to
refill
a
prescription
35
-9-
LSB
5383DP
(8)
88
pf/rh
9/
10
S.F.
_____
H.F.
_____
for
a
chronic
maintenance
drug,
excluding
controlled
1
substances,
if
the
pharmacist,
after
reasonable
efforts,
is
2
unable
to
obtain
authorization
from
the
prescriber
when,
in
3
the
pharmacist’s
professional
judgment,
the
patient’s
life
or
4
health
will
be
endangered
or
an
essential
drug
therapy
will
be
5
disrupted.
6
Division
VI
amends
requirements
to
exempt
influenza
vaccines
7
from
the
requirement
that
a
licensed
pharmacist
review
the
8
statewide
immunization
registry
or
health
information
network
9
prior
to
the
ordering
and
administration
of
a
vaccine
or
10
immunization
authorized
pursuant
to
statewide
protocols.
The
11
bill
also
exempts
influenza
vaccines
from
the
requirement
that
12
a
licensed
pharmacist
report
to
the
statewide
immunization
13
registry
or
health
information
network
following
administration
14
of
an
influenza
vaccine
pursuant
to
statewide
protocols
to
a
15
patient
aged
18
or
older.
16
Division
VII
defines
and
authorizes
collaborative
pharmacy
17
practice
between
pharmacists
and
physicians,
advanced
18
registered
nurse
practitioners,
advanced
practice
registered
19
nurses,
and
dentists
under
both
Code
chapters
124
(controlled
20
substances)
and
Code
chapter
155A
(pharmacy).
21
Division
VIII
codifies
the
provisions
of
2011
Iowa
22
Acts,
chapter
63,
section
36,
relating
to
pharmacy
pilot
or
23
demonstration
research
projects.
The
bill
language
differs
24
from
these
provisions
by
eliminating
language
limiting
the
25
projects
to
those
based
solely
on
prescription
verification
26
and
by
eliminating
the
requirement
that
the
board
report
the
27
approval
or
denial
of
projects
to
the
chairpersons
and
ranking
28
members
of
the
joint
appropriations
subcommittee
on
health
and
29
human
services.
30
-10-
LSB
5383DP
(8)
88
pf/rh
10/
10