Bill Text: IA HF555 | 2023-2024 | 90th General Assembly | Enrolled
Bill Title: A bill for an act relating to the practice of pharmacy, and providing for administrative penalties. (Formerly HSB 202.) Effective date: 07/01/2024.
Spectrum: Committee Bill
Status: (Passed) 2024-04-19 - Signed by Governor. H.J. 926. [HF555 Detail]
Download: Iowa-2023-HF555-Enrolled.html
House
File
555
-
Enrolled
House
File
555
AN
ACT
RELATING
TO
THE
PRACTICE
OF
PHARMACY,
AND
PROVIDING
FOR
ADMINISTRATIVE
PENALTIES.
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
Section
1.
NEW
SECTION
.
155A.2B
Practice
of
pharmacy
——
general
principles.
To
evaluate
whether
an
act
by
a
licensee
or
registrant
under
this
chapter
violates
the
appropriate
standard
of
care,
a
licensee
or
registrant
of
the
board
must
consider
all
of
the
following:
1.
Whether
performance
of
the
act
is
expressly
prohibited
by
a
provision
of
this
chapter.
2.
Whether
performance
of
the
act
is
expressly
prohibited
by
a
rule
adopted
by
the
board.
3.
Whether
performance
of
the
act
is
consistent
with
the
education,
training,
and
experience
of
a
licensee
or
registrant.
4.
Whether
performance
of
the
act
is
within
the
accepted
standard
of
care
that
would
be
provided
in
a
similar
setting
by
a
reasonable
and
prudent
licensee
or
registrant
with
similar
education,
training,
and
experience.
Sec.
2.
Section
155A.3,
subsection
39,
Code
2024,
is
amended
to
read
as
follows:
39.
“Practitioner”
means
a
physician,
dentist,
podiatric
physician,
prescribing
psychologist,
veterinarian,
optometrist,
pharmacist,
physician
assistant,
advanced
registered
nurse
House
File
555,
p.
2
practitioner,
or
other
person
licensed
or
registered
to
prescribe,
distribute,
or
dispense
a
prescription
drug
or
device
in
the
course
of
professional
practice
in
this
state
or
a
person
licensed
by
another
state
in
a
health
field
in
which,
under
Iowa
law,
licensees
in
this
state
may
legally
prescribe
drugs.
Sec.
3.
Section
155A.3,
Code
2024,
is
amended
by
adding
the
following
new
subsection:
NEW
SUBSECTION
.
49A.
“Therapeutic
substitution”
means
the
replacement
of
a
prescribed
drug,
biological
product,
or
device
with
an
alternative
molecule
or
device
with
assumed
equivalent
therapeutic
effect.
The
alternative
drug,
biological
product,
or
device
may
be
within
the
same
class
or
from
another
class
with
assumed
therapeutic
equivalence.
Sec.
4.
Section
155A.7,
Code
2024,
is
amended
by
striking
the
section
and
inserting
in
lieu
thereof
the
following:
155A.7
Pharmacist-intern,
pharmacy
technician,
and
pharmacy
support
person
registration.
1.
Registration
programs
for
pharmacist-interns,
pharmacy
technicians,
and
pharmacy
support
persons
are
established
for
the
purposes
of
identification,
tracking,
and
disciplinary
action
for
the
violation
of
federal
drug
laws
or
regulations,
state
drug
or
pharmacy
laws,
or
rules
of
the
board.
2.
A
person
who
is
or
desires
to
be
a
pharmacist-intern,
pharmacy
technician,
or
pharmacy
support
person
in
this
state
shall
apply
to
the
board
for
registration
on
a
form
prescribed
by
the
board.
a.
A
pharmacist-intern
shall
be
registered
during
internship
training
and
thereafter
pursuant
to
rules
adopted
by
the
board.
b.
An
applicant
for
a
new
pharmacy
technician
registration
or
for
a
pharmacy
technician
renewal
shall
provide
proof
of
current
certification
by
a
national
technician
certification
authority
approved
by
the
board.
A
person
who
is
in
the
process
of
acquiring
national
certification
as
a
pharmacy
technician
and
who
is
in
training
to
become
a
pharmacy
technician
shall
register
with
the
board
as
a
pharmacy
technician.
3.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
on
matters
pertaining
to
pharmacist-intern,
pharmacy
technician,
House
File
555,
p.
3
and
pharmacy
support
person
registration,
renewals,
fees,
training,
national
certification
for
pharmacy
technicians,
approval
of
preceptors
for
pharmacist-interns,
and
other
relevant
matters.
a.
The
board
shall
establish
standards
for
pharmacist-intern
registration.
b.
The
board
shall
not
adopt
rules
pertaining
to
pharmacy
support
person
registration
which
include
any
determination
of
the
competency
of
the
registered
person
and,
notwithstanding
section
272C.2,
subsection
1,
shall
not
require
continuing
education
for
renewal.
4.
The
board
may
deny,
suspend,
or
revoke
the
registration
of
a
pharmacist-intern,
pharmacy
technician,
or
pharmacy
support
person,
or
otherwise
impose
disciplinary
penalties
upon
the
registration
of
a
pharmacy
technician
or
pharmacy
support
person,
for
any
violation
of
the
laws
of
this
state,
another
state,
or
the
United
States
relating
to
prescription
drugs,
controlled
substances,
or
nonprescription
drugs,
or
for
any
violation
of
this
chapter
or
chapter
124,
124B,
126,
147,
205,
or
272C,
or
any
rule
of
the
board.
The
board
may
deny,
suspend,
or
revoke
a
pharmacist-intern
registration
for
failure
to
meet
the
standards
prescribed
by
the
board
pursuant
to
subsection
3.
5.
Responsibility
for
the
actions
of
a
pharmacist-intern,
pharmacy
technician,
or
pharmacy
support
person
working
under
a
licensed
pharmacist’s
delegated
functions
and
reasonable
professional
oversight
shall
remain
with
the
licensed
pharmacist.
Sec.
5.
Section
155A.8,
Code
2024,
is
amended
to
read
as
follows:
155A.8
Requirements
for
pharmacist
Pharmacist
license.
1.
A
person
shall
not
engage
in
the
practice
of
pharmacy
in
this
state
without
a
license.
The
license
shall
be
identified
as
a
pharmacist
license.
2.
A
pharmacist
may
dispense,
administer,
monitor,
and
issue
prescription
drugs,
biological
products,
and
medication
orders
commensurate
with
the
pharmacist’s
training
and
education
and
in
accordance
with
the
appropriate
standard
of
care.
3.
To
qualify
for
a
pharmacist
license,
an
applicant
shall
House
File
555,
p.
4
meet
the
following
requirements:
1.
a.
Be
a
graduate
of
a
school
or
college
of
pharmacy
or
of
a
department
of
pharmacy
of
a
university
recognized
and
approved
by
the
board.
2.
b.
File
proof,
satisfactory
to
the
board,
of
internship
for
a
period
of
time
fixed
by
the
board.
3.
c.
Pass
an
examination
prescribed
by
the
board.
4.
The
board
shall
specify
by
rule
procedures
and
fees
to
renew
a
pharmacist
license
and
penalties
for
late
renewal
or
failure
to
renew
a
pharmacist
license.
Sec.
6.
Section
155A.9,
subsection
2,
Code
2024,
is
amended
to
read
as
follows:
2.
An
applicant
who
is
a
graduate
of
a
school
or
college
of
pharmacy
located
outside
the
United
States
but
who
is
otherwise
qualified
to
apply
for
a
pharmacist
license
in
this
state
may
be
deemed
to
have
satisfied
the
requirements
of
section
155A.8,
subsection
1
section
155A.8,
subsection
3,
paragraph
“a”
,
by
verification
to
the
board
of
the
applicant’s
academic
record
and
graduation
and
by
meeting
other
requirements
established
by
rule
of
the
board.
The
board
may
require
the
applicant
to
pass
an
examination
or
examinations
given
or
approved
by
the
board
to
establish
proficiency
in
English
and
equivalency
of
education
as
a
prerequisite
for
taking
the
licensure
examination
required
in
section
155A.8,
subsection
3
.
Sec.
7.
Section
155A.12,
Code
2024,
is
amended
by
adding
the
following
new
subsections:
NEW
SUBSECTION
.
11.
Engaged
in
conduct
outside
the
accepted
standard
of
care
that
would
be
provided
in
a
similar
setting
by
a
reasonable
and
prudent
applicant
or
licensee.
NEW
SUBSECTION
.
12.
Displayed
incapacity
of
a
nature
preventing
engagement
in
the
practice
of
pharmacy
with
reasonable
skill,
competence,
and
safety
to
the
public.
Sec.
8.
Section
155A.13,
subsection
3,
paragraph
b,
Code
2024,
is
amended
by
striking
the
paragraph
and
inserting
in
lieu
thereof
the
following:
b.
The
board
shall
adopt
rules
for
the
issuance
of
a
special
or
limited-use
pharmacy
license
to
a
telepharmacy
site.
Sec.
9.
Section
155A.13,
subsection
3,
paragraphs
c,
d,
and
e,
Code
2024,
are
amended
by
striking
the
paragraphs.
House
File
555,
p.
5
Sec.
10.
Section
155A.13,
subsection
8,
Code
2024,
is
amended
by
striking
the
subsection.
Sec.
11.
Section
155A.18,
Code
2024,
is
amended
to
read
as
follows:
155A.18
Penalties.
1.
The
board
shall
impose
penalties
as
allowed
under
section
272C.3
.
In
addition,
civil
penalties
not
to
exceed
twenty-five
thousand
dollars,
may
be
imposed.
2.
The
board
may
impose
an
administrative
penalty
of
up
to
five
hundred
dollars
on
a
licensee
or
registrant
who
does
any
of
the
following:
a.
Engages
in
a
practice
regulated
by
this
chapter
without
a
current
license
or
registration.
b.
Employs
a
person
without
a
current
license
or
registration
to
engage
in
a
practice
regulated
by
this
chapter.
c.
Fails
to
complete
the
continuing
education
required
for
renewal
of
a
license
or
registration.
d.
Fails
any
component
of
a
routine
inspection
conducted
by
the
board.
e.
The
assessment
and
payment
of
a
penalty
imposed
pursuant
to
this
subsection
shall
not
be
considered
a
disciplinary
action
or
reported
as
discipline
and
shall
be
confidential.
Sec.
12.
Section
155A.19,
Code
2024,
is
amended
by
striking
the
section
and
inserting
in
lieu
thereof
the
following:
155A.19
Notifications
to
board.
Individuals
and
businesses
licensed
or
registered
pursuant
to
this
chapter
shall
notify
the
board
of
pertinent
changes
related
to
activities
performed
pursuant
to
a
license
or
registration
issued
under
this
chapter,
pursuant
to
rules
of
the
board.
Sec.
13.
Section
155A.23,
Code
2024,
is
amended
by
adding
the
following
new
subsection:
NEW
SUBSECTION
.
4.
a.
A
person
found
in
possession
of
a
drug
or
device
limited
to
dispensation
by
prescription,
unless
the
drug
or
device
was
so
lawfully
dispensed,
commits
a
serious
misdemeanor.
b.
Paragraph
“a”
does
not
apply
to
a
licensed
pharmacy,
licensed
wholesaler,
physician,
veterinarian,
dentist,
podiatric
physician,
optometrist,
advanced
registered
nurse
House
File
555,
p.
6
practitioner,
physician
assistant,
pharmacist,
a
nurse
acting
under
the
direction
of
a
physician,
staff
acting
under
the
direction
of
a
person
licensed
to
prescribe,
or
the
board
of
pharmacy,
its
officers,
agents,
inspectors,
and
representatives,
or
to
a
common
carrier,
manufacturer’s
representative,
or
messenger
when
transporting
the
drug
or
device
in
the
same
unbroken
package
in
which
the
drug
or
device
was
delivered
to
that
person
for
transportation.
Sec.
14.
Section
155A.26,
unnumbered
paragraph
1,
Code
2024,
is
amended
to
read
as
follows:
The
board,
its
officers,
agents,
inspectors
compliance
officers
,
and
representatives,
and
all
peace
officers
within
the
state,
and
all
county
attorneys
shall
enforce
all
provisions
of
this
chapter
,
except
those
specifically
delegated,
and
shall
cooperate
with
all
agencies
charged
with
the
enforcement
of
the
laws
of
the
United
States,
of
this
state,
and
of
all
other
states
relating
to
prescription
drugs.
Officers,
agents,
inspectors
compliance
officers
,
and
representatives
of
the
board
shall
have
the
powers
and
status
of
peace
officers
when
enforcing
the
provisions
of
this
chapter
and
chapters
124
,
126
,
and
205
.
Officers,
agents,
inspectors
compliance
officers
,
and
representatives
of
the
board
of
pharmacy
may:
Sec.
15.
Section
155A.26,
subsection
3,
Code
2024,
is
amended
to
read
as
follows:
3.
Conduct
routine
and
unannounced
inspections
of
pharmacies,
drug
wholesalers,
and
the
offices
or
business
locations
of
all
individuals
and
institutions
authorized
to
have
possession
of
prescription
drugs
including
any
entity
licensed
by
the
board
or
location
authorized
to
possess
controlled
substances
or
prescription
devices,
regardless
of
the
location
of
the
office
or
business.
Sec.
16.
Section
155A.27,
subsection
2,
paragraph
a,
Code
2024,
is
amended
to
read
as
follows:
a.
Beginning
January
1,
2020,
every
Every
prescription
issued
for
a
prescription
drug
shall
be
transmitted
electronically
as
an
electronic
prescription
to
a
pharmacy
by
a
prescriber
or
the
prescriber’s
authorized
agent
unless
exempt
under
paragraph
“b”
.
House
File
555,
p.
7
Sec.
17.
Section
155A.27,
subsection
3,
unnumbered
paragraph
1,
Code
2024,
is
amended
to
read
as
follows:
For
prescriptions
issued
prior
to
January
1,
2020,
or
for
prescriptions
exempt
from
the
electronic
prescription
requirement
in
subsection
2
,
paragraph
“b”
,
a
prescriber
or
the
prescriber’s
authorized
agent
may
transmit
a
prescription
for
a
prescription
drug
to
a
pharmacy
by
any
of
the
following
means:
Sec.
18.
Section
155A.27,
Code
2024,
is
amended
by
adding
the
following
new
subsections:
NEW
SUBSECTION
.
8.
Except
as
specified
in
subsection
9,
a
prescription
for
any
prescription
drug
or
device
which
is
not
a
controlled
substance
shall
not
be
filled
or
refilled
more
than
eighteen
months
after
the
date
on
which
the
prescription
was
issued
and
a
prescription
which
is
authorized
to
be
refilled
shall
not
be
refilled
more
than
twelve
times.
NEW
SUBSECTION
.
9.
A
pharmacist
may
exercise
professional
judgment
by
refilling
a
prescription
drug
order
without
prescriber
authorization
in
accordance
with
the
appropriate
standard
of
care
and
pursuant
to
rules
established
by
the
board.
NEW
SUBSECTION
.
10.
An
authorization
to
refill
a
prescription
drug
order
shall
be
transmitted
to
a
pharmacy
by
a
prescriber
or
the
prescriber’s
authorized
agent
pursuant
to
this
section,
except
that
prescription
drug
orders
for
controlled
substances
shall
be
transmitted
pursuant
to
section
124.308,
and,
if
not
transmitted
directly
by
the
practitioner,
shall
also
include
the
name
and
title
of
the
practitioner’s
agent
completing
the
transmission.
Sec.
19.
Section
155A.32,
Code
2024,
is
amended
by
striking
the
section
and
inserting
in
lieu
thereof
the
following:
155A.32
Drug
product
selection
——
restrictions.
1.
If
an
authorized
practitioner
prescribes
a
drug,
the
pharmacist
may
exercise
professional
judgment
in
the
interest
of
the
patient
by
providing
a
therapeutic
substitution
for
dispensing
and
sale
to
the
patient.
2.
The
pharmacist
shall
not
provide
a
therapeutic
substitution
if
“dispense
as
written”
is
indicated
on
the
prescription.
3.
The
board
shall
adopt
rules
on
proper
recording
and
House
File
555,
p.
8
notification
when
a
therapeutic
substitution
is
made
under
this
section.
Sec.
20.
Section
155A.39,
subsection
6,
Code
2024,
is
amended
to
read
as
follows:
6.
Funds
and
surcharges
collected
under
this
section
shall
be
deposited
in
an
account
and
may
be
used
by
the
board
to
administer
a
program
authorized
by
this
section
,
but
shall
not
be
used
for
costs
incurred
for
a
participant’s
initial
evaluation,
referral
services,
treatment,
or
rehabilitation
subsequent
to
intervention
and
to
assist
licensees
and
registrants
with
costs
incurred
for
participation
in
the
program
.
Sec.
21.
Section
155A.40,
subsection
1,
Code
2024,
is
amended
to
read
as
follows:
1.
The
board
may
request
and
obtain,
notwithstanding
section
692.2,
subsection
5
,
criminal
history
data
for
any
applicant
for
an
initial
or
renewal
license
or
registration
issued
pursuant
to
this
chapter
or
chapter
147
,
any
applicant
for
reinstatement
of
a
license
or
registration
issued
pursuant
to
this
chapter
or
chapter
147
,
or
any
licensee
or
registrant
who
is
being
monitored
as
a
result
of
a
board
order
or
agreement
resolving
an
administrative
disciplinary
action,
for
the
purpose
of
evaluating
the
applicant’s,
licensee’s,
or
registrant’s
eligibility
for
licensure,
registration,
or
suitability
for
continued
practice
of
the
profession.
Criminal
history
data
may
be
requested
for
all
owners,
managers,
and
principal
employees
of
a
pharmacy
,
third-party
logistics
provider,
or
drug
wholesaler
wholesale
distributor
licensed
pursuant
to
this
chapter
.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
to
implement
this
section
.
The
board
shall
inform
the
applicant,
licensee,
or
registrant
of
the
criminal
history
requirement
and
obtain
a
signed
waiver
from
the
applicant,
licensee,
or
registrant
prior
to
submitting
a
criminal
history
data
request.
Sec.
22.
Section
155A.46,
Code
2024,
is
amended
by
adding
the
following
new
subsection:
NEW
SUBSECTION
.
01.
A
pharmacist
may,
pursuant
to
statewide
protocols
developed
and
approved
by
the
board
in
consultation
with
the
department
of
health
and
human
services,
House
File
555,
p.
9
order
and
administer
prescription
drugs,
products,
tests,
or
treatments.
Each
protocol,
as
established
by
rule,
may
define
the
prescription
drugs,
products,
tests,
or
treatments
allowed
to
be
ordered
and
administered,
any
training
or
qualification
required
to
implement
the
protocol,
and
any
additional
requirements
deemed
appropriate
by
the
board.
The
board
shall
not
develop
or
approve
a
statewide
protocol
permitting
a
pharmacist
to
order
and
administer
any
drug
intended
to
induce
an
abortion
as
defined
in
section
146.l.
Sec.
23.
Section
155A.46,
subsection
1,
Code
2024,
is
amended
to
read
as
follows:
1.
A
pharmacist
may,
pursuant
to
statewide
protocols
developed
and
approved
by
the
board
in
consultation
with
the
department
of
health
and
human
services
and
consistent
with
subsection
2,
order
and
administer
an
immunization
or
vaccination.
Each
protocol,
as
established
by
rule,
may
define
the
immunization
or
vaccination
allowed
to
be
ordered
and
administered,
any
training
or
qualification
required
to
implement
the
protocol,
and
any
additional
requirements
deemed
appropriate
by
the
board.
a.
A
pharmacist
may
,
pursuant
to
statewide
protocols
developed
by
the
board
in
consultation
with
the
department
of
health
and
human
services
and
consistent
with
subsection
2
,
order
and
administer
the
following
to
patients
ages
eighteen
years
and
older:
(1)
Opioid
antagonists
for
overdose
reversals.
(2)
Nicotine
replacement
tobacco
cessation
products.
(3)
(1)
An
immunization
or
vaccination
recommended
by
the
United
States
centers
for
disease
control
and
prevention
advisory
committee
on
immunization
practices
in
its
approved
vaccination
schedule
for
adults.
(4)
(2)
An
immunization
or
vaccination
recommended
by
the
United
States
centers
for
disease
control
and
prevention
for
international
travel.
(5)
(3)
A
Tdap
(tetanus,
diphtheria,
acellular
pertussis)
vaccination
in
a
booster
application.
(6)
(4)
Other
emergency
immunizations
or
vaccinations
in
response
to
a
public
health
emergency.
(7)
(5)
An
immunization
or
vaccination
for
COVID-19
as
House
File
555,
p.
10
defined
in
section
686D.2
.
b.
A
pharmacist
may
,
pursuant
to
statewide
protocols
developed
by
the
board
in
consultation
with
the
department
of
health
and
human
services
and
consistent
with
subsection
2
,
order
and
administer
the
following
to
patients
ages
six
months
and
older:
(1)
A
vaccine
An
immunization
or
immunization
vaccination
for
influenza.
(2)
Other
emergency
immunizations
or
vaccines
in
response
to
a
public
health
emergency.
c.
A
pharmacist
may,
pursuant
to
statewide
protocols
developed
by
the
board
in
consultation
with
the
department
of
health
and
human
services
and
consistent
with
subsection
2
,
order
and
administer
the
final
two
doses
in
a
course
of
vaccinations
for
HPV
to
patients
ages
eleven
years
and
older.
d.
Prior
to
the
ordering
and
administration
of
a
vaccination
an
immunization
or
immunization
vaccination
authorized
by
this
subsection
,
pursuant
to
statewide
protocols,
a
licensed
pharmacist
shall
consult
and
review
the
statewide
immunization
registry
or
health
information
network.
The
board
shall
adopt
rules
requiring
the
reporting
of
the
administration
of
vaccines
and
immunizations
and
vaccinations
authorized
by
this
subsection
to
a
patient’s
primary
health
care
provider,
primary
physician,
and
a
statewide
immunization
registry
or
health
information
network.
e.
A
pharmacist
may,
pursuant
to
statewide
protocols
developed
by
the
board
in
consultation
with
the
department
of
health
and
human
services
and
consistent
with
subsection
2
,
order
and
administer
the
following
to
patients
ages
six
years
and
older:
(1)
Point-of-care
testing
and
treatment
for
influenza,
streptococcus
A,
and
COVID-19
as
defined
in
section
686D.2
at
the
point
of
interaction
between
a
pharmacist
and
a
patient.
(2)
Point-of-care
testing
at
the
point
of
interaction
between
a
pharmacist
and
a
patient
in
response
to
a
public
health
emergency.
Sec.
24.
Section
155A.46,
subsection
2,
Code
2024,
is
amended
by
striking
the
subsection
and
inserting
in
lieu
thereof
the
following:
House
File
555,
p.
11
2.
Notwithstanding
any
provision
of
law
to
the
contrary,
a
pharmacist
may
develop
policies,
procedures,
and
protocols
to
carry
out
the
practices
identified
in
section
155A.8,
subsection
2.
Sec.
25.
Section
155A.47,
subsection
1,
Code
2024,
is
amended
to
read
as
follows:
1.
Notwithstanding
any
provision
of
section
147.107,
subsection
2
,
or
section
155A.33
this
chapter
to
the
contrary,
the
board
may
approve
a
pilot
or
demonstration
research
project
of
innovative
applications
in
the
practice
of
pharmacy
to
provide
enhanced
patient
care.
Sec.
26.
Section
514F.7,
subsection
4,
paragraph
a,
Code
2024,
is
amended
to
read
as
follows:
a.
Prevent
a
health
carrier,
health
benefit
plan,
or
utilization
review
organization
from
requiring
a
covered
person
to
try
a
prescription
drug
with
the
same
generic
name
and
demonstrated
bioavailability
or
a
biological
product
that
is
an
interchangeable
biological
product
pursuant
to
section
155A.32
as
defined
in
section
155A.3
prior
to
providing
coverage
for
the
equivalent
branded
prescription
drug.
Sec.
27.
REPEAL.
Sections
155A.6,
155A.6A,
155A.6B,
155A.11,
155A.21,
155A.28,
and
155A.29,
Code
2024,
are
repealed.
______________________________
PAT
GRASSLEY
Speaker
of
the
House
______________________________
AMY
SINCLAIR
President
of
the
Senate
I
hereby
certify
that
this
bill
originated
in
the
House
and
is
known
as
House
File
555,
Ninetieth
General
Assembly.
______________________________
MEGHAN
NELSON
Chief
Clerk
of
the
House
Approved
_______________,
2024
______________________________
KIM
REYNOLDS
Governor
