Senate
File
416
-
Introduced
SENATE
FILE
416
BY
COMMITTEE
ON
STATE
GOVERNMENT
(SUCCESSOR
TO
SSB
1111)
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
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DIVISION
I
1
PHARMACY
TECHNICIANS
AND
PHARMACY
SUPPORT
PERSONS
——
2
REGISTRATION
AND
DELEGATION
OF
FUNCTIONS
3
Section
1.
Section
147.107,
subsection
2,
paragraph
d,
Code
4
2021,
is
amended
to
read
as
follows:
5
d.
A
pharmacist
who
dispenses
prescription
drugs,
including
6
but
not
limited
to
controlled
substances,
for
human
use,
7
may
delegate
nonjudgmental
dispensing
functions
only
when
8
verification
of
the
accuracy
and
completeness
of
the
dispensing
9
is
determined
by
the
pharmacist
in
the
pharmacist’s
physical
10
presence.
The
pharmacist’s
verification
of
the
accuracy
of
the
11
prescription
drug
dispensed
shall
not
be
required
when
verified
12
by
a
certified
pharmacy
technician
in
a
technician
product
13
verification
program
or
a
tech-check-tech
program
as
defined
14
in
section
155A.3
.
The
pharmacist’s
physical
presence
shall
15
not
be
required
when
the
pharmacist
is
remotely
supervising
16
pharmacy
personnel
operating
in
an
approved
a
licensed
17
telepharmacy
site
or
when
utilizing
an
automated
dispensing
18
system
that
utilizes
an
internal
quality
control
assurance
19
plan.
When
utilizing
a
technician
product
verification
program
20
or
tech-check-tech
program
,
or
when
remotely
supervising
21
pharmacy
personnel
operating
at
an
approved
a
licensed
22
telepharmacy
site,
the
pharmacist
shall
utilize
an
internal
23
quality
control
assurance
plan,
in
accordance
with
rules
24
adopted
by
the
board
of
pharmacy,
that
ensures
accuracy
for
25
dispensing.
Automated
dispensing
verification,
technician
26
product
verification,
and
telepharmacy
practice
accuracy
and
27
completeness
remains
the
responsibility
of
the
pharmacist
and
28
shall
be
determined
in
accordance
with
rules
adopted
by
the
29
board
of
pharmacy.
30
Sec.
2.
Section
155A.3,
Code
2021,
is
amended
by
adding
the
31
following
new
subsection:
32
NEW
SUBSECTION
.
35A.
“Pharmacy
support
person”
means
33
a
person,
other
than
a
licensed
pharmacist,
a
registered
34
pharmacist-intern,
or
a
registered
pharmacy
technician,
who
35
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may
perform
nontechnical
duties
assigned
by
a
supervising
1
pharmacist
under
the
pharmacist’s
responsibility
and
2
supervision.
3
Sec.
3.
Section
155A.3,
subsection
46,
Code
2021,
is
amended
4
by
striking
the
subsection.
5
Sec.
4.
Section
155A.6A,
subsections
3
and
4,
Code
2021,
are
6
amended
to
read
as
follows:
7
3.
A
person
who
is
in
the
process
of
acquiring
national
8
certification
as
a
pharmacy
technician
and
who
is
in
training
9
to
become
a
pharmacy
technician
shall
register
with
the
board
10
as
a
pharmacy
technician.
The
registration
shall
be
issued
for
11
a
period
not
to
exceed
one
year
and
shall
not
be
renewable.
12
4.
The
board
shall
adopt
rules
in
accordance
with
13
chapter
17A
on
matters
pertaining
to
pharmacy
technician
14
registration,
application,
forms,
renewals,
fees,
termination
15
of
registration,
tech-check-tech
programs,
technician
product
16
verification
programs,
national
certification,
training,
and
17
any
other
relevant
matters.
18
Sec.
5.
Section
155A.33,
Code
2021,
is
amended
to
read
as
19
follows:
20
155A.33
Delegation
of
technical
functions.
21
A
pharmacist
may
delegate
any
technical
dispensing
functions
22
to
pharmacy
technicians
and
any
nontechnical
functions
to
23
pharmacy
support
persons
,
but
only
if
the
pharmacist
is
24
physically
present
available
to
verify
the
accuracy
and
25
completeness
provide
professional
oversight
of
the
patient’s
26
prescription
prior
to
the
delivery
of
the
prescription
to
the
27
patient
or
the
patient’s
representative
delegated
functions
28
performed
by
the
pharmacy
technician
or
pharmacy
support
29
person
.
However,
the
physical
presence
requirement
does
not
30
apply
when
a
pharmacist
is
utilizing
an
automated
dispensing
31
system
or
a
technician
product
verification
program
or
when
32
a
pharmacist
is
remotely
supervising
a
certified
pharmacy
33
technician
practicing
at
a
telepharmacy
site
approved
by
34
the
board.
When
using
an
automated
dispensing
system
or
a
35
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technician
product
verification
program,
or
when
remotely
1
supervising
a
certified
pharmacy
technician
practicing
at
2
an
approved
telepharmacy
site,
the
pharmacist
shall
utilize
3
an
internal
quality
control
assurance
plan
that
ensures
4
accuracy
for
dispensing.
Verification
of
automated
dispensing,
5
technician
product
verification,
and
telepharmacy
practice
6
accuracy
and
completeness
remains
the
responsibility
of
the
7
pharmacist
and
shall
be
determined
in
accordance
with
rules
8
adopted
by
the
board.
9
DIVISION
II
10
OUTSOURCING
FACILITY
LICENSE
11
Sec.
6.
Section
155A.13C,
subsection
1,
Code
2021,
is
12
amended
by
adding
the
following
new
paragraph:
13
NEW
PARAGRAPH
.
e.
Submit
evidence
of
a
satisfactory
14
inspection
conducted
by
the
home
state
regulatory
authority
15
or
an
entity
approved
by
the
board
in
the
two-year
period
16
immediately
preceding
the
application
which
demonstrates
17
compliance
with
current
good
manufacturing
practices.
In
18
addition,
the
applicant
shall
submit
evidence
of
correction
of
19
all
deficiencies
discovered
in
such
inspections
and
evidence
of
20
compliance
with
all
directives
from
the
home
state
regulatory
21
authority
or
entity
approved
by
the
board.
The
board
may
22
recover
from
an
outsourcing
facility,
prior
to
the
issuance
23
of
a
license
or
license
renewal,
the
costs
associated
with
24
conducting
an
inspection
by
or
on
behalf
of
the
board
for
25
purposes
of
satisfying
the
requirements
of
this
paragraph.
26
DIVISION
III
27
INFORMATION
SHARING
28
Sec.
7.
Section
155A.45,
Code
2021,
is
amended
to
read
as
29
follows:
30
155A.45
Inspection
reports
Reports
——
disclosure.
31
1.
Notwithstanding
section
272C.6,
subsection
4
,
paragraph
32
“a”
,
an
inspection
report
in
possession
of
the
board,
regardless
33
of
whether
the
report
is
based
on
a
routine
inspection
or
an
34
inspection
prompted
by
one
or
more
complaints,
may
be
disclosed
35
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to
the
national
association
of
boards
of
pharmacy’s
inspection
1
network.
2
2.
Notwithstanding
section
272C.6,
subsection
4,
paragraph
3
“a”
,
any
complaints,
investigative
information,
or
data
4
collected
pertaining
to
compounded
human
drug
products
may
be
5
disclosed
to
the
United
States
food
and
drug
administration,
6
including
through
the
use
of
an
information
sharing
network,
in
7
order
to
comply
with
any
memorandum
of
understanding
with
the
8
United
States
food
and
drug
administration.
9
DIVISION
IV
10
PHARMACY
PILOT
OR
DEMONSTRATION
RESEARCH
PROJECTS
11
Sec.
8.
NEW
SECTION
.
155A.47
Pilot
or
demonstration
12
research
projects.
13
1.
Notwithstanding
any
provision
of
section
147.107,
14
subsection
2,
or
section
155A.33
to
the
contrary,
the
board
may
15
approve
a
pilot
or
demonstration
research
project
of
innovative
16
applications
in
the
practice
of
pharmacy
to
provide
enhanced
17
patient
care.
18
2.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
for
19
application
for
and
approval
of
such
projects.
The
rules
may
20
include
exceptions
to
any
existing
rules
under
the
purview
21
of
the
board
as
necessary
for
completion
of
the
project,
22
limited
to
the
duration
of
the
project.
The
board
may
approve
23
a
project
for
no
more
than
eighteen
months.
The
board
may
24
extend
or
renew
a
project
in
accordance
with
board
rules.
All
25
projects
shall
comply
with
the
rules
adopted
for
such
projects.
26
3.
The
board
shall
not
approve
any
project
that
expands
the
27
practice
of
pharmacy
as
defined
in
section
155A.3.
28
Sec.
9.
REPEAL.
2011
Iowa
Acts,
chapter
63,
section
36,
is
29
repealed.
30
EXPLANATION
31
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
32
the
explanation’s
substance
by
the
members
of
the
general
assembly.
33
This
bill
relates
to
pharmacy
practice.
34
Division
I
of
the
bill
eliminates
the
tech-check-tech
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program.
The
board
of
pharmacy
(board)
adopted
administrative
1
rules
to
implement
and
establish
a
technician
product
2
verification
program
as
authorized
by
2018
Iowa
Acts,
3
chapter
1142,
enacting
Code
section
155A.33A.
Division
I
4
eliminates
the
one-year
registration
limitation
for
a
person
in
5
training
to
become
a
pharmacy
technician
and
makes
conforming
6
terminology
changes.
Division
I
also
amends
provisions
7
relating
to
the
delegation
of
technical
functions
between
8
a
pharmacist
and
a
pharmacy
technician
or
pharmacy
support
9
person.
10
Division
II
of
the
bill
requires
a
drug
compounding
11
outsourcing
facility
seeking
licensure
in
the
state
to
12
have
been
inspected
by
the
facility’s
home
state
regulatory
13
authority
or
other
entity
approved
by
the
board
in
the
two-year
14
period
immediately
preceding
the
application,
which
inspection
15
demonstrates
compliance
with
federal
current
good
manufacturing
16
practices.
Division
II
also
allows
the
board
to
recover
from
17
an
outsourcing
facility
costs
associated
with
conducting
an
18
inspection
to
satisfy
the
inspection
requirement.
19
Division
III
of
the
bill
authorizes
the
board
of
pharmacy
to
20
share
information
collected
relating
to
compounded
human
drug
21
products
with
the
United
States
food
and
drug
administration
22
(FDA)
pursuant
to
any
memorandum
of
understanding
between
the
23
board
of
pharmacy
and
the
FDA.
24
Division
IV
of
the
bill
codifies
the
provisions
of
2011
Iowa
25
Acts,
chapter
63,
section
36,
relating
to
pharmacy
pilot
or
26
demonstration
research
projects.
The
language
in
Division
IV
27
differs
from
these
provisions
by
eliminating
language
limiting
28
the
projects
to
those
based
solely
on
prescription
verification
29
and
by
eliminating
the
requirement
that
the
board
report
the
30
approval
or
denial
of
projects
to
the
chairpersons
and
ranking
31
members
of
the
joint
appropriations
subcommittee
on
health
and
32
human
services.
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