House
File
620
-
Introduced
HOUSE
FILE
620
BY
WILLS
A
BILL
FOR
An
Act
relating
to
the
production
of
psilocybin
and
the
1
administration
of
psilocybin
to
persons
with
post-traumatic
2
stress
disorder,
and
providing
penalties.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
TLSB
1463HH
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H.F.
620
Section
1.
Section
124.401,
subsection
5,
Code
2025,
is
1
amended
by
adding
the
following
new
paragraph:
2
NEW
PARAGRAPH
.
g.
A
person
may
knowingly
or
intentionally
3
recommend,
possess,
use,
dispense,
deliver,
transport,
or
4
administer
psilocybin
if
the
recommendation,
possession,
use,
5
dispensing,
delivery,
transporting,
or
administering
is
in
6
accordance
with
the
provisions
of
chapter
124F.
7
Sec.
2.
NEW
SECTION
.
124F.1
Definitions.
8
For
the
purposes
of
this
chapter,
unless
the
context
9
otherwise
requires:
10
1.
“Active
psilocybin”
means
the
psychoactive
chemical
with
11
the
chemical
abstracts
service
registry
number
520-52-5.
12
2.
“Adulterant”
means
a
poisonous
or
deleterious
substance
13
in
a
quantity
that
may
be
injurious
to
health.
14
3.
“Adverse
event”
means
an
injury
or
suspected
injury
to
15
a
patient
that
results
in
an
escalation
of
care,
harm
to
a
16
patient,
or
rescue
of
a
patient
and
occurs
during
a
psilocybin
17
administration
session
or
within
twenty-four
hours
from
when
18
the
administration
session
ended.
19
4.
“Community
location”
means
a
public
or
private
elementary
20
or
secondary
school,
a
church,
a
public
library,
a
public
21
playground,
or
a
public
park.
22
5.
“Cultivation
space”
means,
quantified
in
square
feet,
23
the
horizontal
area
in
which
a
psilocybin
cultivation
facility
24
cultivates
psilocybin,
including
each
level
of
horizontal
area
25
if
the
psilocybin
cultivation
facility
hangs,
suspends,
stacks,
26
or
otherwise
positions
plants
above
other
plants
in
multiple
27
levels.
28
6.
“Department”
means
the
department
of
health
and
human
29
services.
30
7.
“Family
member”
means
a
parent,
stepparent,
spouse,
31
child,
sibling,
stepsibling,
uncle,
aunt,
nephew,
niece,
32
first
cousin,
mother-in-law,
father-in-law,
brother-in-law,
33
sister-in-law,
son-in-law,
daughter-in-law,
grandparent,
or
34
grandchild.
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8.
“Independent
psilocybin
testing
laboratory”
means
a
person
1
that
does
any
of
the
following:
2
a.
Conducts
a
chemical
or
other
analysis
of
psilocybin
or
a
3
psilocybin
product.
4
b.
Acquires,
possesses,
and
transports
psilocybin
or
a
5
psilocybin
product
with
the
intent
to
conduct
a
chemical
or
6
other
analysis
of
the
psilocybin
or
psilocybin
product.
7
9.
“Independent
psilocybin
testing
laboratory
agent”
8
means
an
individual
who
holds
a
valid
psilocybin
production
9
establishment
agent
registration
card
with
a
psilocybin
testing
10
laboratory
designation.
11
10.
“Inventory
control
system”
means
a
system
described
in
12
section
124F.2.
13
11.
“Licensing
board”
means
the
psilocybin
production
14
establishment
licensing
board
created
pursuant
to
section
15
124F.4.
16
12.
“Patient”
means
an
individual
for
whom
a
qualified
17
medical
psilocybin
provider
recommends
psilocybin.
18
13.
“Payment
provider”
means
an
entity
that
contracts
with
19
a
psilocybin
production
establishment
to
facilitate
transfer
20
of
funds
between
the
establishment
and
another
business
or
21
individual.
22
14.
“Psilocybin”
means
a
fresh
mushroom
containing
23
psilocybin
or
psilocin.
24
15.
“Psilocybin
administration
session”
means
the
time
25
period
from
when
a
qualified
medical
provider
administers
26
psilocybin
to
a
patient
to
the
time
the
patient
leaves
the
27
qualified
therapy
provider
location.
28
16.
“Psilocybin
biomass”
means
any
part
of
a
29
psilocybin-containing
fungus.
30
17.
“Psilocybin
byproduct”
means
any
part
of
a
31
psilocybin-containing
mushroom
which
is
not
used
or
intended
32
for
sale.
33
18.
“Psilocybin
cultivation
facility”
means
a
person
that
34
possesses
psilocybin,
grows
or
intends
to
grow
psilocybin,
and
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sells
or
intends
to
sell
psilocybin
to
a
qualified
therapy
1
provider.
2
19.
“Psilocybin
cultivation
facility
agent”
means
3
an
individual
who
holds
a
valid
psilocybin
production
4
establishment
agent
registration
card
with
a
cultivation
5
facility
designation.
6
20.
“Psilocybin
product”
means
any
portion
of
a
7
psilocybin-containing
mushroom
that
has
been
dried
and
is
8
intended
for
oral
consumption
by
a
patient.
9
21.
“Psilocybin
production
establishment”
or
“establishment”
10
means
a
psilocybin
cultivation
facility
or
an
independent
11
psilocybin
testing
laboratory.
12
22.
“Psilocybin
production
establishment
agent
registration
13
card”
means
a
registration
card
issued
by
the
department
that
14
authorizes
an
individual
to
act
as
a
psilocybin
production
15
establishment
agent,
and
that
designates
the
type
of
psilocybin
16
production
establishment
for
which
an
individual
is
authorized
17
to
act
as
an
agent.
18
23.
“Qualified
medical
psilocybin
provider”
means
a
19
physician
and
surgeon
or
osteopathic
physician
and
surgeon
20
licensed
pursuant
to
chapter
148,
a
physician
assistant
21
licensed
pursuant
to
chapter
148C,
an
advanced
registered
22
nurse
practitioner
licensed
under
chapter
152,
or
an
advanced
23
practice
registered
nurse
under
chapter
152E,
who
is
registered
24
by
the
department
under
section
124F.24
to
recommend
treatment
25
with
psilocybin.
26
24.
“Qualified
therapy
provider”
means
a
physician
and
27
surgeon
or
osteopathic
physician
and
surgeon
licensed
pursuant
28
to
chapter
148,
a
physician
assistant
licensed
pursuant
29
to
chapter
148C,
an
advanced
registered
nurse
practitioner
30
licensed
under
chapter
152,
an
advanced
practice
registered
31
nurse
under
chapter
152E,
a
psychologist
licensed
pursuant
32
to
chapter
154B,
or
a
social
worker
licensed
pursuant
to
33
chapter
154C
who
is
registered
by
the
department
to
administer
34
treatment
with
psilocybin.
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25.
“Qualified
therapy
provider
agent”
means
an
individual
1
who
holds
a
valid
qualified
therapy
provider
agent
registration
2
card.
3
26.
“Qualified
therapy
provider
agent
registration
card”
4
means
a
registration
card
issued
by
the
department
that
5
authorizes
an
individual
to
act
as
a
qualified
therapy
provider
6
agent.
7
27.
“Qualified
therapy
provider
location”
or
“provider
8
location”
means
a
facility
with
all
of
the
following:
9
a.
A
single,
secure
public
entrance.
10
b.
A
security
system
with
a
backup
power
source
that
detects
11
and
records
entry
and
provides
notice
of
an
unauthorized
entry
12
to
law
enforcement
when
the
facility
is
closed.
13
c.
A
lock
or
equivalent
restrictive
security
feature
on
any
14
area
where
the
psilocybin
or
psilocybin
product
is
stored
at
15
the
facility.
16
Sec.
3.
NEW
SECTION
.
124F.2
Inventory
control
system.
17
1.
Each
psilocybin
production
establishment
and
qualified
18
therapy
provider
shall
maintain
an
inventory
control
system
19
that
meets
all
of
the
requirements
of
this
section.
20
2.
An
inventory
control
system
shall
do
all
of
the
21
following:
22
a.
Track,
in
real
time,
psilocybin
and
psilocybin
product
23
using
a
unique
identifier
from
the
time
psilocybin
is
ready
to
24
be
harvested.
25
b.
Maintain
in
real
time
a
record
of
the
amount
of
26
psilocybin
or
psilocybin
product
in
the
possession
of
the
27
establishment
or
provider.
28
c.
Include
a
video
recording
system
that
is
tamper
proof
and
29
does
all
of
the
following:
30
(1)
Tracks
all
handling
and
processing
of
psilocybin
or
31
psilocybin
product
in
the
establishment
or
provider
location.
32
(2)
Stores
each
video
record
for
at
least
forty-five
days.
33
3.
A
psilocybin
production
establishment
or
qualified
34
therapy
provider
shall
allow
the
department,
or
a
financial
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institution
designated
by
the
department,
to
validate
1
transactions
to
access
the
inventory
control
system
at
any
2
time.
3
4.
The
department
shall
adopt
rules
pursuant
to
chapter
4
17A
to
implement
this
section,
and
the
rules
shall
include
5
requirements
for
aggregate
or
batch
records
regarding
the
6
planting
and
propagation
of
psilocybin
before
being
tracked,
7
and
which
may
include
compatibility
standards
for
inventory
8
control
systems.
9
Sec.
4.
NEW
SECTION
.
124F.3
Notice
to
prospective
and
10
current
public
employees.
11
Prior
to
giving
a
current
employee
an
assignment
or
duty
that
12
arises
from
or
directly
relates
to
an
obligation
under
this
13
chapter,
or
hiring
a
prospective
employee
whose
assignments
or
14
duties
would
include
an
assignment
or
duty
that
arises
from
or
15
directly
relates
to
an
obligation
under
this
chapter,
a
state
16
employer
or
a
political
subdivision
employer
shall
give
the
17
employee
or
prospective
employee
a
written
notice
that
the
18
employee’s
or
prospective
employee’s
job
duties
may
require
the
19
employee
or
prospective
employee
to
engage
in
conduct
which
is
20
in
violation
of
the
criminal
laws
of
the
United
States.
21
Sec.
5.
NEW
SECTION
.
124F.4
Psilocybin
production
22
establishment
licensing
board.
23
1.
a.
There
is
created
within
the
department
the
psilocybin
24
production
establishment
licensing
board.
The
board
shall
25
consist
of
the
following
members,
appointed
by
the
director
of
26
the
department:
27
(1)
One
member
of
the
public
with
knowledge
of
psilocybin.
28
(2)
One
member
with
knowledge
and
experience
in
the
29
pharmaceutical
or
nutraceutical
manufacturing
industry.
30
(3)
One
member
representing
law
enforcement.
31
(4)
One
member
who
is
a
chemist
or
researcher
with
32
experience
in
manufacturing
and
who
is
associated
with
a
33
research
university.
34
(5)
One
member
who
has
a
background
in
fungus
or
mushroom
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cultivation
and
processing.
1
(6)
The
director
or
the
director’s
designee,
who
shall
serve
2
as
the
chairperson
of
the
board
and
as
a
nonvoting
member,
3
except
to
cast
a
deciding
vote
in
the
event
of
a
tie.
4
b.
A
person
is
ineligible
for
appointment
to
the
board
if
5
any
of
the
following
apply:
6
(1)
The
person
has
any
commercial
or
ownership
interest
in
a
7
psilocybin
production
establishment.
8
(2)
The
person
is
associated
with
a
business
that
has
an
9
owner,
officer,
director,
or
employee
whose
family
member
10
holds
a
license
or
has
an
interest
in
a
psilocybin
production
11
establishment.
12
(3)
The
person
is
employed
or
contracted
to
lobby
on
behalf
13
of
a
psilocybin
production
establishment.
14
c.
The
director
shall
ensure
that
no
two
members
of
the
15
board
are
employed
by
or
represent
the
same
business
or
16
nonprofit
organization.
17
d.
Members
of
the
board
shall
serve
a
term
of
four
years,
18
except
that
initial
members
of
the
board
shall
be
appointed
19
for
staggered
terms
such
that
the
director
appoints
two
or
20
three
board
members
every
two
years.
The
director
shall
fill
a
21
vacancy
on
the
board
for
the
balance
of
the
unexpired
term.
22
e.
The
director
may
remove
a
member
of
the
board
for
cause,
23
neglect
of
duty,
inefficiency,
or
malfeasance.
24
f.
Members
of
the
board
shall
serve
without
compensation
but
25
may
be
reimbursed
for
actual
expenses.
26
2.
The
board
shall
meet
as
called
by
the
chairperson
to
do
27
all
of
the
following:
28
a.
Review
each
license
application
for
compliance
with
this
29
chapter
and
rules
adopted
by
the
department.
30
b.
Conduct
a
public
hearing
to
consider
a
license
31
application.
32
c.
Make
a
determination
on
a
license
application.
33
3.
The
board
shall
hold
a
public
hearing
to
review
34
a
psilocybin
production
establishment’s
license
if
the
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establishment
changes
ownership
interest
by
more
than
twenty
1
percent,
changes
location,
or
as
necessary
based
on
the
2
recommendation
of
the
department.
3
4.
The
board
shall
meet
annually
in
December
to
consider
4
psilocybin
production
establishment
license
renewal
5
applications.
A
representative
from
each
applicant
for
renewal
6
shall
attend
the
meeting.
The
board
shall
consider
the
amount
7
of
biomass
the
applicant
produces,
the
amount
of
biomass
the
8
applicant
projects
to
produce,
the
current
square
footage
of
9
growing
area
the
applicant
uses,
and
the
square
footage
of
10
growing
area
the
applicant
projects
to
use.
11
5.
The
board
is
not
subject
to
dissolution
pursuant
to
12
section
4A.5.
13
Sec.
6.
NEW
SECTION
.
124F.5
Psilocybin
production
14
establishment
——
license.
15
1.
A
person
shall
not
operate
a
psilocybin
production
16
establishment
unless
the
person
holds
a
psilocybin
production
17
establishment
license
issued
by
the
licensing
board
pursuant
to
18
this
chapter.
19
2.
The
department
shall
adopt
rules
pursuant
to
chapter
17A
20
to
develop
a
process
for
soliciting
and
evaluating
applications
21
for
a
psilocybin
production
establishment
license.
22
3.
An
applicant
for
a
psilocybin
production
establishment
23
license
shall
submit
all
of
the
following:
24
a.
The
proposed
name
of
the
establishment
and
the
address
25
where
the
establishment
will
be
located.
26
b.
The
name
and
address
of
any
individual
who
has
any
of
the
27
following:
28
(1)
For
a
publicly
traded
company,
a
financial
or
voting
29
interest
of
two
percent
or
greater
in
the
proposed
psilocybin
30
production
establishment.
31
(2)
For
a
privately
held
company,
a
financial
or
voting
32
interest
in
the
proposed
psilocybin
production
establishment.
33
(3)
The
power
to
direct
the
management
or
control
of
the
34
proposed
psilocybin
production
establishment.
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c.
An
operating
plan,
approved
by
the
department,
that
1
complies
with
section
124F.8
and
any
laws
that
the
municipality
2
or
county
in
which
the
person
is
located
adopts
regarding
the
3
operation
of
psilocybin
production
establishments.
4
d.
A
statement
that
the
applicant
will
obtain
and
maintain
5
a
performance
bond
that
a
surety
authorized
to
transact
surety
6
business
in
this
state
issues
in
an
amount
of
at
least
one
7
hundred
thousand
dollars
for
each
psilocybin
cultivation
8
facility
license,
or
at
least
fifty
thousand
dollars
for
each
9
independent
psilocybin
testing
laboratory
license.
10
e.
An
application
fee
in
an
amount
determined
by
the
11
department.
12
f.
A
description
of
any
investigatory
or
adverse
action
13
taken
by
a
licensing
jurisdiction,
government
agency,
law
14
enforcement
agency,
or
court
in
any
state
for
any
violation
15
or
detrimental
conduct
in
relation
to
any
of
the
applicant’s
16
psilocybin-related
operations
or
businesses.
17
4.
A
psilocybin
production
establishment
shall
not
be
18
located
within
one
thousand
feet
of
a
community
location
or
19
in
or
within
five
hundred
feet
of
an
area
that
is
zoned
as
20
primarily
residential.
The
board
may
grant
a
waiver
to
reduce
21
the
proximity
requirements
in
this
subsection
by
up
to
twenty
22
percent
if
the
board
determines
that
it
is
not
reasonably
23
feasible
for
the
applicant
to
site
the
proposed
psilocybin
24
production
establishment
without
the
waiver.
25
5.
Upon
the
approval
of
an
application
for
a
license
under
26
this
section,
the
applicant
shall
pay
to
the
department
the
27
initial
licensing
fee,
as
determined
by
the
department
by
rule,
28
and
the
department
shall
inform
the
department
of
public
safety
29
of
the
license
approval.
30
6.
A
psilocybin
production
establishment
may
be
located
31
at
the
same
location
as
a
medical
cannabidiol
manufacturer
32
licensed
pursuant
to
section
124E.6
if
a
separate
license
is
33
obtained
for
each.
34
7.
If
the
licensing
board
receives
more
than
one
application
35
-8-
LSB
1463HH
(6)
91
ss/ko
8/
45
H.F.
620
for
a
psilocybin
production
establishment
within
the
same
city
1
or
town,
the
licensing
board
shall
consult
with
the
local
2
land
use
authority
before
approving
any
of
the
applications
3
pertaining
to
that
city
or
town.
4
8.
The
licensing
board
shall
not
issue
a
license
to
operate
5
an
independent
psilocybin
testing
laboratory
to
any
of
the
6
following
persons:
7
a.
A
person
who
holds
a
license
or
has
an
ownership
interest
8
to
operate
a
psilocybin
cultivation
facility.
9
b.
A
person
who
has
an
owner,
officer,
director,
or
employee
10
whose
family
member
holds
a
license
or
has
an
ownership
11
interest
in
a
psilocybin
cultivation
facility.
12
c.
A
person
who
has
an
ownership
interest
in
a
psilocybin
13
cultivation
facility.
14
9.
The
licensing
board
shall
not
issue
a
license
to
operate
15
a
psilocybin
production
establishment
to
an
applicant
if
an
16
individual
described
in
subsection
3,
paragraph
“b”
,
has
been
17
convicted
of
a
misdemeanor
for
drug
distribution,
or
convicted
18
of
a
felony,
or
is
younger
than
twenty-one
years
old.
19
10.
The
licensing
board
may,
at
the
discretion
of
the
20
licensing
board,
grant
preference
to
an
applicant
who
currently
21
holds
a
medical
cannabidiol
manufacturer
license
issued
22
pursuant
to
section
124E.6.
23
11.
The
licensing
board
may
revoke
a
license
issued
pursuant
24
to
this
section
if
any
of
the
following
apply:
25
a.
The
psilocybin
production
establishment
does
not
26
begin
operations
within
one
year
after
the
date
on
which
the
27
licensing
board
issues
the
initial
license.
28
b.
An
individual
psilocybin
production
establishment
29
operated
by
the
licensee
has
violated
the
same
provision
of
30
this
chapter
three
times.
31
c.
An
individual
described
in
subsection
3,
paragraph
“b”
,
32
is
convicted
of
a
misdemeanor
for
drug
distribution,
or
is
33
convicted
of
a
felony.
34
d.
The
licensee
fails
to
cooperate
with
an
investigation
35
-9-
LSB
1463HH
(6)
91
ss/ko
9/
45
H.F.
620
of
the
psilocybin
production
establishment
conducted
by
the
1
licensing
board.
2
e.
The
psilocybin
production
establishment
demonstrates
3
a
willful
or
reckless
disregard
for
the
requirements
of
this
4
chapter
or
the
rules
of
the
department.
5
f.
The
licensing
board
determines
that
the
psilocybin
6
production
establishment
no
longer
meets
the
minimum
standards
7
for
licensure
and
operation
of
the
psilocybin
production
8
establishment.
9
g.
For
an
independent
psilocybin
testing
laboratory,
10
the
independent
psilocybin
testing
laboratory
fails
to
11
substantially
meet
the
performance
standards
adopted
by
the
12
department
by
rule.
13
12.
If
the
municipality
or
county
where
the
licensed
14
psilocybin
production
establishment
will
be
located
requires
15
a
local
land
use
permit,
a
person
who
is
issued
a
psilocybin
16
production
establishment
license
under
this
chapter
shall
17
submit
to
the
licensing
board
a
copy
of
the
licensee’s
approved
18
land
use
permit
within
one
hundred
twenty
days
after
the
date
19
on
which
the
licensing
board
issues
the
license.
20
13.
The
department
shall
deposit
fees
imposed
under
this
21
section
into
the
general
fund
of
the
state.
22
14.
The
department
shall
begin
accepting
applications
under
23
this
chapter
on
July
1,
2026.
24
15.
The
licensing
board’s
authority
to
issue
a
license
under
25
this
section
shall
be
plenary
and
not
subject
to
review.
26
16.
The
licensing
board
shall
not
issue
more
than
four
27
licenses
to
operate
an
independent
psilocybin
testing
28
laboratory.
29
17.
The
department
may
operate
or
partner
with
a
research
30
university
to
operate
an
independent
psilocybin
testing
31
laboratory.
32
18.
A
psilocybin
production
establishment
license
shall
not
33
be
transferable
or
assignable.
34
19.
If
ownership
of
a
psilocybin
production
establishment
35
-10-
LSB
1463HH
(6)
91
ss/ko
10/
45
H.F.
620
changes
by
fifty
percent
or
more,
the
psilocybin
production
1
establishment
shall
submit
a
new
application
pursuant
to
this
2
section.
3
Sec.
7.
NEW
SECTION
.
124F.6
Psilocybin
production
4
establishment
owners
and
directors
——
criminal
background
checks.
5
1.
The
division
of
criminal
investigation
of
the
department
6
of
public
safety
shall
conduct
a
thorough
investigation
of
7
each
applicant
for
a
psilocybin
production
establishment
8
license
as
in
a
substantially
similar
manner
as
provided
in
9
section
124E.19.
The
division
shall
report
the
results
of
the
10
investigation
to
the
department.
11
2.
The
department
shall
collect
a
fee
from
the
applicant,
12
determined
by
the
department
by
rule,
to
cover
the
costs
of
the
13
investigation
by
the
division
of
criminal
investigation
of
the
14
department
of
public
safety.
The
department
shall
remit
the
15
fee
to
the
division.
16
Sec.
8.
NEW
SECTION
.
124F.7
License
renewal.
17
The
licensing
board
shall
renew
a
license
issued
pursuant
18
to
section
124F.5
on
an
annual
basis
if
all
of
the
following
19
apply:
20
1.
The
licensee
meets
all
of
the
requirements
for
initial
21
licensure.
22
2.
The
licensing
board
does
not
identify
a
significant
23
failure
of
compliance
with
this
chapter
or
grounds
for
24
revocation.
25
3.
The
licensee
pays
a
renewal
fee
as
determined
by
the
26
department
by
rule.
27
Sec.
9.
NEW
SECTION
.
124F.8
Operating
plan.
28
A
person
applying
for
a
psilocybin
production
establishment
29
license
or
license
renewal
shall
submit
to
the
department
for
30
the
department’s
review
a
proposed
operating
plan
that
includes
31
all
of
the
following:
32
1.
A
description
of
the
physical
characteristics
of
the
33
proposed
facility
or,
for
a
psilocybin
cultivation
facility,
no
34
more
than
two
facility
locations,
including
a
floor
plan
and
an
35
-11-
LSB
1463HH
(6)
91
ss/ko
11/
45
H.F.
620
architectural
elevation.
1
2.
A
description
of
the
credentials
and
experience
of
2
each
officer,
director,
and
owner
of
the
proposed
psilocybin
3
production
establishment,
and
of
any
highly
skilled
or
4
experienced
prospective
employee.
5
3.
The
psilocybin
production
establishment’s
employee
6
training
standards.
7
4.
A
security
plan.
8
5.
A
description
of
the
psilocybin
production
9
establishment’s
inventory
control
system.
10
6.
Storage
protocols
to
ensure
that
psilocybin
is
stored
in
11
a
manner
that
is
sanitary
and
preserves
the
integrity
of
the
12
psilocybin.
13
7.
For
a
psilocybin
cultivation
facility:
14
a.
Psilocybin
cultivation
practices,
including
the
15
facility’s
intended
pesticide
and
fertilizer
use.
16
b.
Square
footage
under
cultivation
and
anticipated
17
psilocybin
yield.
18
8.
For
an
independent
psilocybin
testing
laboratory:
19
a.
Psilocybin
and
psilocybin
product
testing
capacity.
20
b.
Psilocybin
and
psilocybin
product
testing
equipment.
21
c.
Testing
methods,
standards,
practices,
and
procedures
for
22
testing
psilocybin
or
psilocybin
product.
23
Sec.
10.
NEW
SECTION
.
124F.9
Psilocybin
cultivation
24
facilities
——
number
of
licenses.
25
The
licensing
board
shall
not
issue
more
than
two
licenses
to
26
operate
a
psilocybin
cultivation
facility.
If
the
recipient
27
of
a
license
ceases
operations
for
any
reason,
or
otherwise
28
abandons
the
license,
the
board
may
grant
the
abandoned
license
29
to
another
applicant.
30
Sec.
11.
NEW
SECTION
.
124F.10
Psilocybin
production
31
establishment
agent
——
registration.
32
1.
An
individual
shall
not
act
as
a
psilocybin
production
33
establishment
agent
unless
the
department
registers
the
34
individual
as
a
psilocybin
production
establishment
agent,
35
-12-
LSB
1463HH
(6)
91
ss/ko
12/
45
H.F.
620
regardless
of
whether
the
individual
is
a
seasonal,
temporary,
1
or
permanent
employee.
2
2.
None
of
the
following
individuals
shall
serve
as
a
3
psilocybin
production
establishment
agent,
have
a
financial
4
or
voting
interest
of
two
percent
or
greater
in
a
psilocybin
5
production
establishment,
or
have
the
power
to
direct
or
6
cause
the
management
or
control
of
a
psilocybin
production
7
establishment:
8
a.
An
advanced
registered
nurse
practitioner
licensed
under
9
chapter
152
or
an
advanced
practice
registered
nurse
under
10
chapter
152E.
11
b.
An
individual
licensed
under
chapter
148
to
practice
12
medicine
and
surgery
or
osteopathic
medicine
and
surgery.
13
c.
A
physician
assistant
licensed
under
chapter
148C.
14
3.
An
independent
psilocybin
testing
laboratory
agent
may
15
not
act
as
a
psilocybin
cultivation
facility
agent.
16
4.
The
department
shall,
within
fifteen
business
days
17
from
the
date
on
which
the
department
receives
a
complete
18
application
from
a
psilocybin
production
establishment
on
19
behalf
of
a
prospective
psilocybin
production
establishment
20
agent,
register
and
issue
a
psilocybin
production
establishment
21
agent
registration
card
to
the
prospective
psilocybin
22
production
establishment
agent
who
successfully
passes
a
23
criminal
background
investigation
as
provided
in
section
124F.6
24
if
the
psilocybin
production
establishment
does
all
of
the
25
following:
26
a.
Provides
to
the
department
the
prospective
psilocybin
27
production
establishment
agent’s
name
and
address.
28
b.
Pays
a
fee
to
the
department
in
an
amount
determined
by
29
the
department
by
rule.
30
5.
The
department
shall
designate,
on
an
individual’s
31
psilocybin
production
establishment
agent
registration
card,
32
the
type
of
psilocybin
production
establishment
for
which
the
33
individual
is
authorized
to
act
as
an
agent.
34
6.
a.
A
psilocybin
production
establishment
agent
shall
35
-13-
LSB
1463HH
(6)
91
ss/ko
13/
45
H.F.
620
comply
with
either
a
certification
standard
developed
by
the
1
department
by
rule,
or
a
certification
standard
that
the
2
department
has
reviewed
and
approved.
3
b.
A
certification
standard
described
in
paragraph
“a”
shall
4
include
training
in
all
of
the
following:
5
(1)
Iowa
medical
psilocybin
law.
6
(2)
For
a
psilocybin
cultivation
facility
agent,
psilocybin
7
cultivation
best
practices.
8
(3)
For
an
independent
psilocybin
testing
laboratory
agent,
9
psilocybin
laboratory
testing
best
practices.
10
7.
A
psilocybin
production
establishment
agent
registration
11
card
shall
expire
two
years
from
the
date
the
department
issued
12
the
card.
A
psilocybin
production
establishment
agent
may
13
renew
the
agent’s
registration
card
if
the
agent
is
still
14
eligible
to
hold
a
psilocybin
production
establishment
agent
15
registration
card
and
pays
a
fee
determined
by
the
department
16
by
rule.
17
8.
a.
A
psilocybin
production
establishment
agent
shall
18
carry
the
individual’s
psilocybin
production
card
with
the
19
agent
at
all
times
when
the
agent
is
on
the
premises
of
20
a
psilocybin
production
establishment
where
the
agent
is
21
registered,
or
when
the
agent
is
transporting
psilocybin
or
22
psilocybin
product.
23
b.
If
a
psilocybin
production
establishment
agent
possesses
24
psilocybin
or
psilocybin
product
and
produces
the
registration
25
card
while
handling
or
transporting
psilocybin
or
psilocybin
26
product,
there
is
a
rebuttable
presumption
that
the
agent
27
possesses
the
psilocybin
or
psilocybin
product
legally
and
28
a
law
enforcement
officer
does
not
have
probable
cause,
29
based
solely
on
the
agent’s
possession
of
the
psilocybin
or
30
psilocybin
product,
to
believe
that
the
individual
is
engaging
31
in
illegal
activity.
32
c.
A
psilocybin
production
establishment
agent
who
fails
to
33
carry
the
individual’s
psilocybin
production
card
as
required
34
by
paragraph
“a”
is
guilty
of
the
following
offenses:
35
-14-
LSB
1463HH
(6)
91
ss/ko
14/
45
H.F.
620
(1)
For
a
first
offense,
or
second
offense
within
a
two-year
1
period,
a
simple
misdemeanor
punishable
by
a
fine
of
one
2
hundred
dollars.
3
(2)
For
a
third
or
subsequent
offense
within
a
two-year
4
period,
a
simple
misdemeanor
punishable
as
provided
by
law.
5
d.
For
each
violation
of
paragraph
“c”
,
the
department
may
6
assess
the
relevant
psilocybin
production
establishment
a
fine
7
of
up
to
five
thousand
dollars.
8
Sec.
12.
NEW
SECTION
.
124F.11
Psilocybin
production
9
establishment
——
general
operation
requirements.
10
1.
A
psilocybin
production
establishment
shall
operate
in
11
accordance
with
the
operating
plan
submitted
by
the
psilocybin
12
production
establishment
pursuant
to
section
124F.8.
A
13
psilocybin
production
establishment
shall
notify
the
department
14
prior
to
implementing
a
change
to
the
establishment’s
operating
15
plan.
The
department
shall
inform
the
establishment
of
any
16
deficiencies
in
the
new
operating
plan.
17
2.
a.
Except
as
provided
in
paragraph
“b”
,
a
psilocybin
18
production
establishment
shall
operate
in
a
facility
that
19
is
accessible
only
by
an
individual
with
a
valid
psilocybin
20
production
establishment
agent
registration
card.
21
b.
A
psilocybin
production
establishment
may
authorize
22
an
individual
who
is
at
least
eighteen
years
of
age
and
who
23
is
not
a
psilocybin
production
establishment
agent
to
access
24
the
psilocybin
production
establishment
if
the
psilocybin
25
production
establishment
tracks
and
monitors
the
individual
at
26
all
times
while
the
individual
is
at
the
psilocybin
production
27
establishment,
and
maintains
a
record
of
the
individual’s
28
access,
including
arrival
and
departure.
29
3.
A
psilocybin
production
establishment
shall
not
employ
30
an
individual
who
is
younger
than
twenty-one
years
of
age
or
31
who
has
been
convicted
of
a
misdemeanor
for
drug
distribution,
32
or
convicted
of
a
felony.
33
4.
A
psilocybin
production
establishment
shall
operate
in
a
34
facility
that
has
all
of
the
following:
35
-15-
LSB
1463HH
(6)
91
ss/ko
15/
45
H.F.
620
a.
A
single,
secure
public
entrance.
1
b.
A
security
system
with
a
backup
power
source
that
does
2
all
of
the
following:
3
(1)
Detects
and
records
entry
into
the
psilocybin
4
production
establishment.
5
(2)
Provides
notice
of
an
unauthorized
entry
to
law
6
enforcement
when
the
psilocybin
production
establishment
is
7
closed.
8
(3)
Secures
any
area
where
the
psilocybin
production
9
establishment
stores
psilocybin
or
a
psilocybin
product.
10
Sec.
13.
NEW
SECTION
.
124F.12
Inspections.
11
1.
The
department
may
inspect
the
records
and
facility
of
a
12
psilocybin
production
establishment
at
any
time
during
business
13
hours
to
determine
if
the
psilocybin
production
establishment
14
complies
with
this
chapter.
15
2.
An
inspection
under
this
section
may
include
all
of
the
16
following:
17
a.
Inspection
of
a
site,
facility,
vehicle,
book,
record,
18
paper,
document,
data,
and
other
physical
or
electronic
19
information.
20
b.
Questioning
of
any
relevant
individual.
21
c.
Observation
of
an
independent
psilocybin
testing
22
laboratory’s
methods,
standards,
practices,
and
procedures.
23
d.
The
sampling
of
a
specimen
of
psilocybin
or
psilocybin
24
product
sufficient
for
testing
purposes.
25
e.
Inspection
of
equipment,
an
instrument,
a
tool,
or
26
machinery,
including
a
container
or
label.
27
3.
In
conducting
an
inspection
under
this
section,
the
28
department
may
review
and
make
copies
of
a
book,
record,
paper,
29
document,
data,
or
other
physical
or
electrical
information,
30
including
financial
data,
sales
data,
shipping
data,
pricing
31
data,
and
employee
data.
32
4.
The
department
may
impose
a
fee,
or
a
license
or
33
registration
suspension
or
revocation,
if
a
psilocybin
34
production
establishment
fails
to
comply
with
this
section.
35
-16-
LSB
1463HH
(6)
91
ss/ko
16/
45
H.F.
620
Sec.
14.
NEW
SECTION
.
124F.13
Advertising.
1
1.
A
psilocybin
production
establishment
shall
not
2
advertise
to
the
general
public
in
any
medium,
except
that
a
3
psilocybin
production
establishment
may
advertise
an
employment
4
opportunity
at
the
psilocybin
production
establishment.
5
2.
The
department
shall
adopt
rules
pursuant
to
chapter
17A
6
for
standards
relating
to
advertising
by
a
qualified
medical
7
psilocybin
provider
or
qualified
therapy
provider.
The
rules
8
shall
ensure
that
advertising
by
a
qualified
medical
psilocybin
9
provider
or
qualified
therapy
provider
does
not
imply
that
the
10
psilocybin
may
be
used
for
recreational
purposes.
11
Sec.
15.
NEW
SECTION
.
124F.14
Psilocybin
transportation.
12
1.
No
individual
other
than
the
following
may
transport
13
psilocybin
or
a
psilocybin
product:
14
a.
A
registered
psilocybin
production
establishment
agent.
15
b.
A
qualified
therapy
provider.
16
c.
A
registered
qualified
therapy
provider
agent.
17
d.
An
agent
of
the
department
conducting
an
inspection
18
pursuant
to
section
124F.12.
19
2.
An
individual
transporting
psilocybin
or
psilocybin
20
product
shall
be
employed
by
the
individual
authorizing
the
21
transportation
and
possess
a
manifest
that
includes
all
of
the
22
following:
23
a.
A
unique
identifier
that
links
the
psilocybin
or
24
psilocybin
product
to
a
relevant
inventory
control
system.
25
b.
The
origin
and
destination
information
for
any
psilocybin
26
or
psilocybin
product
that
the
person
is
transporting.
27
c.
The
departure
and
arrival
times
of
the
individual
28
transporting
the
psilocybin
or
psilocybin
product.
29
3.
A
registered
psilocybin
production
establishment
30
agent
transporting
psilocybin
or
psilocybin
product
without
31
a
manifest
as
provided
in
subsection
2
is
guilty
of
a
simple
32
misdemeanor
punishable
by
a
fine
of
one
hundred
dollars.
33
However,
if
the
registered
psilocybin
production
establishment
34
agent
is
carrying
more
psilocybin
or
psilocybin
product
than
is
35
-17-
LSB
1463HH
(6)
91
ss/ko
17/
45
H.F.
620
indicated
on
the
manifest,
other
than
a
de
minimis
amount,
the
1
registered
psilocybin
production
establishment
agent
is
subject
2
to
penalties
as
provided
in
chapter
124.
3
4.
This
section
shall
not
prohibit
the
department
from
4
taking
administrative
enforcement
action
against
a
psilocybin
5
production
establishment
or
another
person
for
failing
to
make
6
a
transport
in
compliance
with
this
section.
7
Sec.
16.
NEW
SECTION
.
124F.15
Psilocybin
——
excess
and
8
disposal.
9
1.
As
used
in
this
section,
“psilocybin
waste”
means
waste
10
and
unused
material
from
the
cultivation
and
production
of
11
psilocybin
or
psilocybin
product
under
this
chapter.
12
2.
A
psilocybin
production
establishment
shall
do
all
of
the
13
following:
14
a.
Render
psilocybin
waste
unusable
and
unrecognizable
15
before
transporting
it
from
the
psilocybin
production
16
establishment.
17
b.
Dispose
of
the
psilocybin
waste
in
compliance
with
all
18
applicable
state
and
federal
laws.
19
3.
A
person
shall
not
transport
or
dispose
of
psilocybin
20
waste
other
than
as
provided
in
this
section.
21
Sec.
17.
NEW
SECTION
.
124F.16
Psilocybin
production
22
establishment
——
local
control.
23
1.
A
local
government
shall
allow
a
psilocybin
production
24
establishment
to
operate
in
any
zone
designated
for
industrial
25
use
unless
the
local
government
has
designated
by
ordinance
26
at
least
one
industrial
zone
for
the
operation
of
psilocybin
27
production
establishments
before
a
person
submits
an
28
application
for
the
establishment
of
a
psilocybin
production
29
establishment
to
the
local
government.
30
2.
A
local
government
shall
allow
a
psilocybin
production
31
establishment
to
operate
in
any
zone
designated
for
32
agricultural
use
unless
the
local
government
has
designated
by
33
ordinance
at
least
one
agricultural
zone
for
the
operation
of
34
psilocybin
production
establishments
before
a
person
submits
an
35
-18-
LSB
1463HH
(6)
91
ss/ko
18/
45
H.F.
620
application
for
the
establishment
of
a
psilocybin
production
1
establishment
to
the
local
government.
2
3.
A
psilocybin
production
establishment
may
operate
on
3
land
that
a
local
government
has
not
zoned.
4
4.
A
local
government
shall
not
do
any
of
the
following:
5
a.
Revoke
from,
or
refuse
to
issue
a
license
or
permit
to,
6
a
psilocybin
production
establishment
on
the
sole
basis
that
7
the
applicant
or
psilocybin
production
establishment
violates
8
federal
law
regarding
the
legal
status
of
psilocybin.
9
b.
Require
a
certain
distance
between
a
psilocybin
10
production
establishment
and
another
psilocybin
production
11
establishment
or
a
retail
tobacco
store
as
defined
in
section
12
142D.2.
13
c.
Enforce
an
ordinance
against
a
psilocybin
production
14
establishment
that
was
not
in
effect
on
the
date
the
psilocybin
15
production
establishment
submitted
a
complete
application
to
16
the
local
government.
17
Sec.
18.
NEW
SECTION
.
124F.17
Psilocybin
cultivation
18
facility
——
growing
and
harvesting.
19
1.
A
psilocybin
cultivation
facility
shall
use
a
unique
20
identifier
that
is
connected
to
the
facility’s
inventory
21
control
system
to
identify
all
of
the
following:
22
a.
Each
unique
harvest
of
psilocybin.
23
b.
Each
batch
of
psilocybin
that
the
facility
transfers
to
24
an
independent
psilocybin
testing
laboratory.
25
c.
Any
psilocybin
waste,
as
defined
in
section
124F.15,
of
26
which
the
psilocybin
cultivation
facility
disposes.
27
2.
A
psilocybin
cultivation
facility
shall
identify
28
psilocybin
biomass
as
psilocybin
byproduct
or
psilocybin
29
product
before
transferring
the
psilocybin
biomass
from
the
30
facility.
31
3.
A
psilocybin
cultivation
facility
shall
destroy
32
psilocybin
cultivation
byproduct
as
provided
in
section
33
124F.15.
34
Sec.
19.
NEW
SECTION
.
124F.18
Psilocybin
cultivation
35
-19-
LSB
1463HH
(6)
91
ss/ko
19/
45
H.F.
620
facility
——
sales.
1
1.
A
psilocybin
cultivation
facility
shall
not
sell
a
2
product
other
than
a
psilocybin
product
or
educational
material
3
related
to
the
medical
use
of
psilocybin.
4
2.
A
psilocybin
cultivation
facility
shall
not
sell
a
5
product
to
a
person
other
than
a
qualified
therapy
provider
or
6
a
registered
agent
of
a
qualified
therapy
provider.
7
Sec.
20.
NEW
SECTION
.
124F.19
Psilocybin
cultivation
8
facility
——
labeling.
9
1.
A
psilocybin
cultivation
facility
shall
label
a
10
psilocybin
or
psilocybin
product
with
the
amount
of
active
11
psilocybin
in
the
psilocybin
or
psilocybin
product.
12
2.
The
department
may
adopt
rules
pursuant
to
chapter
17A
to
13
establish
labeling
requirements
for
a
psilocybin
product.
14
Sec.
21.
NEW
SECTION
.
124F.20
Independent
psilocybin
15
testing
laboratory
——
psilocybin
and
psilocybin
product
testing.
16
1.
The
department
shall
adopt
rules
pursuant
to
chapter
17A
17
to
do
all
of
the
following:
18
a.
Identify
the
adulterant
analyses
required
to
be
performed
19
on
psilocybin
or
psilocybin
product.
20
b.
Determine
the
level
of
each
adulterant
that
is
safe
for
21
human
consumption.
22
c.
Establish
protocols
for
a
recall
of
psilocybin
or
23
psilocybin
product
by
a
psilocybin
production
establishment.
24
2.
The
department
may
require
an
independent
psilocybin
25
testing
laboratory
to
test
for
a
toxin
if
the
department
26
receives
information
indicating
the
potential
presence
of
a
27
toxin,
or
the
department’s
inspector
has
reason
to
believe
a
28
toxin
may
be
present
based
on
the
inspection
of
a
facility.
29
3.
A
psilocybin
production
establishment
may
not
transfer
30
psilocybin
or
psilocybin
product
to
a
qualified
therapy
31
provider
until
an
independent
psilocybin
testing
laboratory
32
tests
a
representative
sample
of
the
psilocybin
or
psilocybin
33
product
as
provided
by
the
department
by
rule.
34
4.
Before
the
sale
of
a
psilocybin
product,
an
independent
35
-20-
LSB
1463HH
(6)
91
ss/ko
20/
45
H.F.
620
psilocybin
testing
laboratory
shall
identify
and
quantify
the
1
amount
of
active
psilocybin
present
in
the
psilocybin
product.
2
5.
The
department
shall
adopt
rules
pursuant
to
chapter
3
17A
for
standards,
methods,
practices,
and
procedures
for
the
4
testing
of
psilocybin
and
psilocybin
products
by
an
independent
5
psilocybin
laboratory.
6
6.
The
department
may
require
an
independent
psilocybin
7
testing
laboratory
to
participate
in
a
proficiency
evaluation
8
that
the
department
conducts,
or
that
an
organization
that
the
9
department
approves
conducts.
10
Sec.
22.
NEW
SECTION
.
124F.21
Independent
psilocybin
11
testing
laboratory
——
inspections.
12
1.
If
an
independent
psilocybin
testing
laboratory
13
determines
that
the
results
of
a
laboratory
test
indicate
that
14
a
psilocybin
or
psilocybin
product
batch
may
be
unsafe
for
15
human
use:
16
a.
The
independent
psilocybin
testing
laboratory
shall
17
report
the
laboratory
test
results
and
the
psilocybin
or
18
psilocybin
product
batch
to
the
department
and
the
psilocybin
19
cultivation
facility
from
which
the
batch
originated.
20
b.
The
department
shall
place
a
hold
on
the
psilocybin
or
21
psilocybin
products
to
conduct
a
root
cause
analysis
of
the
22
defective
batch
and
make
a
determination
as
to
the
root
cause.
23
The
psilocybin
cultivation
facility
that
grew
the
psilocybin
24
may
appeal
the
determination
of
the
department.
25
2.
If
the
department
determines
that
psilocybin
or
26
psilocybin
product
prepared
by
a
psilocybin
cultivation
27
establishment
is
unsafe
for
human
consumption,
the
department
28
may
seize,
embargo,
or
destroy
the
psilocybin
or
psilocybin
29
product
batch
as
provided
in
section
124F.15.
30
3.
If
an
independent
psilocybin
testing
laboratory
31
determines
that
the
results
of
a
lab
test
indicate
that
the
32
active
psilocybin
content
of
psilocybin
or
a
psilocybin
product
33
batch
diverges
more
than
ten
percent
from
the
amount
the
label
34
indicates,
the
psilocybin
cultivation
facility
shall
not
sell
35
-21-
LSB
1463HH
(6)
91
ss/ko
21/
45
H.F.
620
the
psilocybin
or
psilocybin
product
batch
unless
the
facility
1
replaces
the
incorrect
label
with
a
label
that
correctly
2
indicates
the
active
psilocybin
content.
3
Sec.
23.
NEW
SECTION
.
124F.22
Psilocybin
electronic
4
verification
system.
5
1.
The
department,
in
consultation
with
the
department
of
6
agriculture
and
land
stewardship
and
the
department
of
public
7
safety,
shall
adopt
rules
pursuant
to
chapter
17A
for
the
8
creation
and
operation
of
an
electronic
verification
system
9
that,
at
minimum,
does
all
of
the
following:
10
a.
Allows
a
qualified
medical
psilocybin
provider
to
access
11
dispensing
information
regarding
a
patient
of
the
qualified
12
medical
psilocybin
provider,
electronically
recommend
or
renew
13
a
recommendation
for
psilocybin
or
a
psilocybin
product,
14
connect
with
an
inventory
control
system
that
a
psilocybin
15
production
establishment
uses
to
track
in
real
time
and
archive
16
purchases
of
any
psilocybin
or
psilocybin
product,
and
connect
17
with
an
inventory
control
system
that
a
psilocybin
production
18
establishment
utilizes.
19
b.
Allows
access
by
all
of
the
following:
20
(1)
The
department
to
the
extent
necessary
to
carry
out
the
21
department’s
functions
and
responsibilities.
22
(2)
The
department
of
inspections,
appeals,
and
licensing
23
to
carry
out
the
functions
and
responsibilities
related
to
24
the
participation
of
qualified
medical
psilocybin
providers
25
and
qualified
therapy
providers
in
the
recommendation
and
26
administration
of
psilocybin.
27
c.
Creates
a
record
each
time
a
person
accesses
the
system
28
that
identifies
the
person
who
accessed
the
system
and
the
29
individual
whose
records
the
person
accessed.
30
d.
Keeps
a
current
record
of
the
total
number
of
individuals
31
who
have
a
psilocybin
recommendation
issued
pursuant
to
section
32
124F.23.
33
2.
The
department
may
release
limited
data
from
the
34
electronic
verification
system
for
the
purposes
of
conducting
35
-22-
LSB
1463HH
(6)
91
ss/ko
22/
45
H.F.
620
research,
issuing
required
reports,
or
for
other
official
1
department
purposes.
2
3.
a.
A
person
who
knowingly
and
intentionally
releases
any
3
information
from
the
state
electronic
verification
system
in
4
violation
of
this
section
is
guilty
of
a
class
“D”
felony.
5
b.
A
person
who
negligently
or
recklessly
releases
any
6
information
from
the
state
electronic
verification
system
in
7
violation
of
this
section
is
guilty
of
a
serious
misdemeanor.
8
4.
a.
A
person
who
obtains
or
attempts
to
obtain
9
information
from
the
state
electronic
verification
system
by
10
misrepresentation
or
fraud
is
guilty
of
a
class
“D”
felony.
11
b.
A
person
who
obtains
or
attempts
to
obtain
information
12
from
the
state
electronic
verification
system
for
a
purpose
13
other
than
a
purpose
authorized
in
this
chapter
is
guilty
of
a
14
class
“D”
felony.
15
5.
a.
Except
as
provided
in
paragraph
“b”
,
a
person
who
16
knowingly
and
intentionally
uses,
releases,
publishes,
or
17
otherwise
makes
available
to
any
other
person
information
18
obtained
from
the
state
electronic
verification
system
for
19
any
purpose
other
than
a
purpose
specified
in
this
section
is
20
guilty
of
a
class
“D”
felony.
21
b.
This
subsection
shall
not
prohibit
a
person
who
22
rightfully
obtains
information
from
the
state
electronic
23
verification
system
from
including
the
information
in
24
the
person’s
medical
chart
or
file
for
access
by
a
person
25
authorized
to
review
the
medical
chart
or
file,
providing
the
26
information
to
a
person
in
accordance
with
the
requirements
of
27
the
federal
Health
Insurance
Portability
and
Accountability
Act
28
of
1996,
Pub.
L.
No.
104-191,
or
discussing
or
sharing
that
29
information
about
the
patient
with
the
patient.
30
Sec.
24.
NEW
SECTION
.
124F.23
Psilocybin
recommendation
31
——
limitations
——
expiration.
32
1.
No
more
than
five
thousand
individuals
shall
33
simultaneously
hold
a
psilocybin
recommendation
from
a
34
qualified
medical
psilocybin
provider.
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2.
An
individual’s
psilocybin
recommendation
expires
if
the
1
individual
has
not
received
treatment
from
a
qualified
therapy
2
provider
with
psilocybin
or
a
psilocybin
product
by
the
later
3
of
one
year
from
the
date
the
qualified
medical
psilocybin
4
provider
provided
the
recommendation,
or
one
year
from
the
date
5
of
the
individual’s
most
recent
administration
of
psilocybin
or
6
a
psilocybin
product
by
a
qualified
therapy
provider.
7
Sec.
25.
NEW
SECTION
.
124F.24
Qualified
medical
psilocybin
8
provider
registration
——
continuing
education
——
treatment
9
recommendation.
10
1.
An
individual
shall
not
recommend
a
medical
psilocybin
11
treatment
unless
the
department
registers
the
individual
as
a
12
qualified
medical
psilocybin
provider
under
this
section.
13
2.
The
department
shall,
within
fifteen
days
after
the
date
14
the
department
receives
an
application
from
an
individual,
15
register
and
issue
a
qualified
medical
psilocybin
provider
16
registration
card
to
the
individual
if
the
individual
does
all
17
of
the
following:
18
a.
Provides
to
the
department
the
individual’s
name
and
19
address.
20
b.
Provides
to
the
department
a
report
detailing
the
21
individual’s
completion
of
the
applicable
continuing
education
22
requirements
described
in
subsection
3.
23
c.
Provides
to
the
department
evidence
that
the
individual
24
holds
a
license
that
qualifies
the
individual
as
a
qualified
25
medical
psilocybin
provider.
26
d.
Pays
an
application
fee
as
determined
by
the
department
27
by
rule.
28
e.
For
an
applicant
on
or
after
January
1,
2026,
provides
29
the
information
required
by
subsection
9.
30
3.
a.
An
individual
applying
for
initial
registration
31
or
renewal
of
a
registration
shall
complete
a
continuing
32
education
program
as
determined
by
the
department
by
rule.
The
33
continuing
education
program
shall
be
offered
by
the
department
34
or
a
continuing
education
provider
approved
by
the
department.
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The
continuing
education
program
shall
address
all
of
the
1
following:
2
(1)
This
chapter.
3
(2)
General
information
about
psilocybin
under
federal
and
4
state
law.
5
(3)
The
latest
scientific
research
on
medical
psilocybin,
6
including
risks
and
benefits.
7
(4)
Best
practices
for
recommending
the
form
and
dosage
of
8
psilocybin.
9
(5)
Systems
and
receptors
affected
by
psilocybin.
10
(6)
Mechanisms
of
action.
11
(7)
Drug
interactions.
12
(8)
Diagnostic
criteria.
13
(9)
Contraindications.
14
(10)
Side
effects
and
mitigation
of
side
effects.
15
(11)
Administrative
set
and
setting,
including
physical
16
patient
safety.
17
(12)
Integration.
18
(13)
Potential
outcomes.
19
(14)
Ethical
considerations.
20
(15)
Discharge
safety
planning.
21
b.
An
applicant
for
initial
registration
shall
complete
22
sixteen
hours
of
continuing
education.
A
qualified
medical
23
psilocybin
provider
shall
complete
four
hours
of
continuing
24
education
every
two
years.
25
4.
A
qualified
medical
psilocybin
provider
shall
not
26
recommend
psilocybin
to
a
patient,
or
renew
a
recommendation
27
for
psilocybin,
unless
the
qualified
medical
psilocybin
28
provider
has
done
all
of
the
following:
29
a.
Completed
and
documented
in
the
patient’s
medical
record
30
a
thorough
assessment
of
the
patient’s
condition
and
medical
31
history
based
on
the
appropriate
standard
of
care.
32
b.
Verified
that
the
patient
has
post-traumatic
stress
33
disorder.
34
c.
Verified
that
the
patient
is
at
least
twenty-one
years
35
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old.
1
d.
Met
with
the
patient
face
to
face
if
the
qualified
2
medical
psilocybin
provider
has
not
recommended
a
psilocybin
3
treatment
to
the
patient
in
the
past.
4
5.
a.
Except
as
provided
in
paragraph
“b”
,
an
individual
5
shall
not
advertise
that
the
individual
recommends
medical
6
psilocybin
treatment.
7
b.
A
qualified
medical
psilocybin
provider,
or
a
clinic
or
8
office
that
employs
a
qualified
medical
psilocybin
provider,
9
may
advertise
the
following:
10
(1)
The
provider’s
or
clinic’s
name
and
logo.
11
(2)
That
the
individual
treats
post-traumatic
stress
12
disorder.
13
(3)
That
the
individual
is
registered
as
a
qualified
medical
14
psilocybin
provider
and
recommends
medical
psilocybin.
15
(4)
A
scientific
study
regarding
medical
psilocybin
use.
16
6.
a.
A
qualified
medical
psilocybin
provider
registration
17
card
shall
expire
two
years
from
the
date
the
department
issued
18
the
card.
19
b.
The
department
shall
adopt
rules
pursuant
to
chapter
17A
20
for
the
renewal
of
a
medical
psilocybin
provider
registration
21
card.
22
7.
The
department
may
revoke
a
medical
psilocybin
provider
23
registration
card
if
a
qualified
medical
psilocybin
provider
24
fails
to
maintain
compliance
with
this
section.
25
8.
A
qualified
medical
psilocybin
provider
shall
not
26
receive
any
compensation
or
benefit
for
the
qualified
27
medical
psilocybin
provider’s
medical
psilocybin
treatment
28
recommendation
from
a
psilocybin
production
establishment
or
an
29
owner,
officer,
director,
board
member,
employee,
or
agent
of
a
30
psilocybin
production
establishment.
31
9.
On
or
before
January
1
of
each
year,
a
qualified
medical
32
provider
shall
report
to
the
department
all
of
the
following:
33
a.
That
the
qualified
medical
psilocybin
provider,
or
the
34
entity
that
employs
the
qualified
medical
psilocybin
provider,
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represents
online
or
in
printed
material
that
the
qualified
1
medical
psilocybin
provider
is
a
qualified
medical
psilocybin
2
provider
or
offers
medical
psilocybin
recommendations
to
3
patients,
if
applicable.
4
b.
The
fee
amount
that
the
qualified
medical
psilocybin
5
provider,
or
the
entity
that
employs
the
qualified
medical
6
psilocybin
provider,
charges
a
patient
for
a
medical
psilocybin
7
recommendation,
either
as
an
actual
cash
rate
or,
if
the
8
psilocybin
provider
or
entity
bills
insurance,
an
average
cash
9
rate.
10
Sec.
26.
NEW
SECTION
.
124F.25
Standard
of
care
——
provider
11
not
liable
——
no
private
right
of
action.
12
1.
A
qualified
medical
psilocybin
provider
or
a
qualified
13
therapy
provider
who
recommends
or
administers
psilocybin
in
14
compliance
with
this
chapter
shall
not
be
subject
to
a
civil
or
15
criminal
penalty,
or
license
discipline,
solely
for
violating
16
a
federal
law
or
regulation
that
prohibits
recommending,
17
prescribing,
possessing,
or
dispensing
psilocybin
or
a
18
psilocybin
product.
19
2.
This
chapter
shall
not
be
construed
to
reduce
or
20
negate
the
duty
of
a
qualified
medical
psilocybin
provider
or
21
qualified
therapy
provider
to
use
reasonable
and
ordinary
care
22
in
the
treatment
of
a
patient.
23
Sec.
27.
NEW
SECTION
.
124F.26
Nondiscrimination
for
medical
24
care
or
government
employment.
25
1.
For
purposes
of
medical
care,
including
an
organ
or
26
tissue
transplant,
a
patient’s
use
of
psilocybin
as
provided
in
27
this
chapter
is
the
equivalent
of
authorized
use
of
any
other
28
medication
used
at
the
discretion
of
a
physician,
and
does
29
not
constitute
the
use
of
an
illicit
substance
or
otherwise
30
disqualify
an
individual
from
needed
medical
care.
31
2.
a.
Except
as
provided
in
paragraph
“b”
,
the
state
or
a
32
political
subdivision
of
the
state
shall
treat
an
employee’s
33
use
of
medical
psilocybin
as
provided
in
this
chapter
in
34
the
same
way
the
state
or
political
subdivision
treats
an
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employee’s
use
of
any
prescribed
controlled
substance,
and
an
1
employee’s
medical
psilocybin
recommendation
from
a
qualified
2
medical
psilocybin
provider
in
the
same
way
the
state
or
3
political
subdivision
treats
an
employee’s
prescription
for
any
4
prescribed
controlled
substance.
5
b.
A
state
or
political
subdivision
employee
who
has
a
valid
6
medical
psilocybin
registration
shall
not
be
subject
to
adverse
7
action
for
failing
a
drug
test
due
to
psilocybin
or
psilocin
8
without
evidence
that
the
employee
was
impaired
or
otherwise
9
adversely
affected
in
the
employee’s
job
performance
due
to
the
10
use
of
medical
psilocybin.
This
paragraph
shall
not
apply
in
11
any
of
the
following
circumstances:
12
(1)
The
employee’s
use
of
psilocybin
jeopardizes
federal
13
funding,
a
federal
security
clearance,
or
any
other
federal
14
background
determination
required
for
the
employee’s
position.
15
(2)
The
employee’s
position
is
dependent
on
a
license
16
or
peace
officer
certification
that
is
subject
to
federal
17
regulations,
including
18
U.S.C.
§922(g)(3).
18
(3)
An
employee
who
uses
medical
psilocybin
during
the
19
twelve
hours
immediately
preceding
the
employee’s
shift
or
20
during
the
employee’s
shift.
21
Sec.
28.
NEW
SECTION
.
124F.27
Insurance
——
coverage
22
requirement.
23
This
chapter
shall
not
be
construed
to
require
an
insurer,
24
a
third-party
administrator,
or
an
employer
to
pay
for
or
25
reimburse
an
employee
for
psilocybin
or
psilocybin
product.
26
Sec.
29.
NEW
SECTION
.
124F.28
Approved
drugs.
27
This
chapter
shall
not
be
construed
to
restrict
or
otherwise
28
affect
the
prescription,
distribution,
or
dispensing
of
a
29
product
that
the
United
States
food
and
drug
administration
has
30
approved.
31
Sec.
30.
NEW
SECTION
.
124F.29
Qualified
therapy
32
provider
registration
——
continuing
education
——
psilocybin
33
administration.
34
1.
An
individual
shall
not
administer
a
medical
psilocybin
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treatment
unless
the
department
registers
the
individual
as
1
a
qualified
medical
psilocybin
therapist
as
provided
in
this
2
section.
3
2.
The
department
shall,
within
fifteen
days
after
the
date
4
the
department
receives
an
application
from
an
individual,
5
register
and
issue
a
qualified
medical
psilocybin
therapist
6
registration
card
to
the
individual
if
the
individual
does
all
7
of
the
following:
8
a.
Provides
to
the
department
the
individual’s
name
and
9
address.
10
b.
Provides
to
the
department
the
address
of
the
clinic
11
at
which
the
individual
will
be
administering
psilocybin
to
12
patients.
13
c.
Provides
to
the
department
a
report
detailing
the
14
individual’s
completion
of
the
applicable
continuing
education
15
requirements
described
in
subsection
3.
16
d.
Certifies
to
the
department
that
the
individual
has
17
installed
and
maintains
an
inventory
control
system.
18
e.
Provides
to
the
department
evidence
that
the
individual
19
holds
a
license
that
qualifies
the
individual
as
a
qualified
20
medical
psilocybin
provider.
21
f.
Pays
an
application
fee
as
determined
by
the
department
22
by
rule.
23
g.
Provides
to
the
department
an
emergency
transport
plan
24
for
patients
who
experience
a
medical
emergency
during
the
25
course
of
treatment.
26
3.
a.
An
individual
applying
for
initial
registration
27
or
renewal
of
a
registration
shall
complete
a
continuing
28
education
program
as
determined
by
the
department
by
rule.
The
29
continuing
education
program
shall
be
offered
by
the
department
30
or
a
continuing
education
provider
approved
by
the
department.
31
The
continuing
education
program
shall
address
all
of
the
32
following:
33
(1)
This
chapter.
34
(2)
General
information
about
psilocybin
under
federal
and
35
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state
law.
1
(3)
The
latest
scientific
research
on
medical
psilocybin,
2
including
risks
and
benefits.
3
(4)
Best
practices
for
recommending
the
form
and
dosage
of
4
psilocybin.
5
(5)
Systems
and
receptors
affected
by
psilocybin.
6
(6)
Mechanisms
of
action.
7
(7)
Drug
interactions.
8
(8)
Diagnostic
criteria.
9
(9)
Contraindications.
10
(10)
Side
effects
and
mitigation
of
side
effects.
11
(11)
Administrative
set
and
setting,
including
physical
12
patient
safety.
13
(12)
Integration.
14
(13)
Potential
outcomes.
15
(14)
Ethical
considerations.
16
(15)
Discharge
safety
planning.
17
b.
An
applicant
for
initial
registration
shall
complete
18
eighty
hours
of
continuing
education.
A
qualified
therapy
19
provider
shall
complete
four
hours
of
continuing
education
20
every
two
years.
21
4.
A
qualified
therapy
provider
shall
only
administer
22
psilocybin
to
a
patient
when
all
of
the
following
requirements
23
are
met:
24
a.
The
patient
has
a
recommendation
issued
by
a
qualified
25
medical
psilocybin
provider.
26
b.
The
qualified
medical
therapy
provider
has
obtained
and
27
reviewed
the
patient’s
mental
health
history.
28
c.
The
qualified
therapy
provider
has
provided
the
patient
29
with
a
safety
data
sheet
created
by
the
department
which
30
outlines
the
potential
risks
of
psilocybin
use.
31
d.
There
are
unexpired
rescue
medications
on
site,
as
32
determined
by
the
department
by
rule.
33
e.
The
administration
session
is
video-recorded
and
the
34
video
recording
is
preserved
for
one
year
from
the
date
of
the
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620
session,
or
the
patient
gives
written,
informed
consent
waiving
1
the
video-recording
requirement.
2
f.
The
qualified
therapy
provider
has
a
contractual
3
relationship
with
a
licensed
physician
and
surgeon
or
4
osteopathic
physician
and
surgeon
who
remains
on
call
during
5
the
course
of
the
administration
session
in
case
the
patient
6
requires
nonemergency
medical
intervention.
7
5.
A
qualified
therapy
provider
shall
only
administer
8
psilocybin
or
a
psilocybin
product
in
a
qualified
therapy
9
provider
location.
10
6.
a.
Except
as
provided
in
paragraph
“b”
,
an
individual
11
shall
not
advertise
that
the
individual
administers
medical
12
psilocybin
treatment.
13
b.
A
qualified
therapy
provider
or
clinic
or
office
14
that
employs
a
qualified
therapy
provider
may
advertise
the
15
following:
16
(1)
The
provider’s
or
clinic’s
name
and
logo.
17
(2)
That
the
individual
treats
post-traumatic
stress
18
disorder.
19
(3)
That
the
individual
is
registered
as
a
qualified
therapy
20
provider
and
administers
medical
psilocybin.
21
(4)
A
scientific
study
regarding
medical
psilocybin
use.
22
7.
a.
A
qualified
therapy
provider
registration
card
23
expires
two
years
from
the
date
the
department
issues
the
card.
24
b.
The
department
shall
adopt
rules
pursuant
to
chapter
17A
25
for
the
renewal
of
a
qualified
therapy
provider
registration
26
card.
27
8.
Within
seven
days
of
the
date
on
which
an
adverse
event
28
occurs,
a
qualified
therapy
provider
shall
submit
to
the
29
department
a
report
containing
all
of
the
following:
30
a.
The
age
and
sex
of
the
patient.
31
b.
The
patient’s
preexisting
health
conditions,
if
any.
32
c.
The
amount
of
psilocybin
administered
to
the
patient.
33
d.
Factors
which
contributed
to
the
adverse
event.
34
e.
The
nature
and
severity
of
the
adverse
event.
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f.
The
ultimate
outcome
of
the
adverse
event.
1
9.
The
department
may
revoke
a
qualified
therapy
provider
2
registration
card
if
a
qualified
therapy
provider
fails
to
3
maintain
compliance
with
this
section.
4
Sec.
31.
NEW
SECTION
.
124F.30
Qualified
therapy
provider
5
agent
——
registration.
6
1.
An
individual
shall
not
act
as
a
qualified
therapy
7
provider
agent
unless
the
department
registers
the
individual
8
as
a
qualified
therapy
provider
agent,
regardless
of
whether
9
the
individual
is
a
seasonal,
temporary,
or
permanent
employee.
10
2.
The
department
shall,
within
fifteen
business
days
11
after
the
date
the
department
receives
a
complete
application
12
from
a
qualified
therapy
provider
agent,
register
and
issue
13
a
qualified
therapy
provider
agent
registration
card
to
the
14
prospective
agent
who
successfully
passes
a
criminal
background
15
investigation
as
provided
in
section
124F.6
if
the
prospective
16
agent
does
all
of
the
following:
17
a.
Provides
to
the
department
the
prospective
agent’s
name
18
and
address.
19
b.
Pays
a
fee
to
the
department
in
an
amount
determined
by
20
the
department
by
rule.
21
3.
a.
A
qualified
therapy
provider
agent
shall
comply
with
22
either
a
certification
standard
developed
by
the
department
23
by
rule,
or
a
certification
standard
that
the
department
has
24
reviewed
and
approved.
25
b.
A
certification
standard
described
in
paragraph
“a”
shall
26
include
training
in
Iowa
medical
psilocybin
law.
27
4.
A
qualified
therapy
provider
agent
registration
card
28
shall
expire
two
years
from
the
date
the
department
issued
the
29
card.
A
qualified
therapy
provider
agent
may
renew
the
agent’s
30
registration
card
if
the
agent
is
still
eligible
to
hold
a
31
qualified
therapy
provider
agent
registration
card
and
pays
a
32
fee
determined
by
the
department
by
rule.
33
5.
a.
A
qualified
therapy
provider
agent
shall
carry
the
34
individual’s
qualified
therapy
provider
agent
card
with
the
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agent
at
all
times
when
the
agent
is
handling
psilocybin
or
1
psilocybin
product.
2
b.
If
a
qualified
therapy
provider
agent
possesses
3
psilocybin
or
psilocybin
product
and
produces
the
registration
4
card
in
the
agent’s
possession,
there
is
a
rebuttable
5
presumption
that
the
agent
possesses
the
psilocybin
or
6
psilocybin
product
legally
and
a
law
enforcement
officer
does
7
not
have
probable
cause,
based
solely
on
the
agent’s
possession
8
of
the
psilocybin
or
psilocybin
product,
to
believe
that
the
9
individual
is
engaging
in
illegal
activity.
10
c.
A
qualified
therapy
provider
agent
who
fails
to
carry
11
the
individual’s
qualified
therapy
provider
agent
card
with
the
12
agent
as
required
by
paragraph
“a”
is
guilty
of
the
following
13
offenses:
14
(1)
For
a
first
offense,
or
a
second
offense
within
a
15
two-year
period,
a
simple
misdemeanor
punishable
by
a
fine
of
16
one
hundred
dollars.
17
(2)
For
a
third
offense,
or
a
subsequent
offense
within
a
18
two-year
period,
a
simple
misdemeanor.
19
d.
For
each
violation
of
paragraph
“c”
,
the
department
may
20
assess
the
relevant
qualified
therapy
provider
a
fine
of
up
to
21
two
thousand
five
hundred
dollars.
22
Sec.
32.
NEW
SECTION
.
124F.31
Reports.
23
1.
a.
On
or
before
November
1,
2025,
and
by
November
1
of
24
each
year
thereafter,
the
department
shall
submit
a
report
to
25
the
general
assembly
including
all
of
the
following:
26
(1)
The
number
of
patients
for
whom
psilocybin
has
been
27
recommended.
28
(2)
The
age
and
county
of
patients.
29
(3)
The
number
of
qualified
medical
psilocybin
providers.
30
(4)
The
number
of
license
applications
and
renewal
31
applications
received.
32
(5)
The
number
of
licenses
the
department
has
issued
in
each
33
county.
34
(6)
The
number
of
licenses
the
department
has
revoked.
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(7)
The
expenses
incurred
and
revenues
generated
from
the
1
medical
psilocybin
program.
2
(8)
The
number
and
nature
of
adverse
events
reported.
3
b.
The
department
shall
not
include
personally
identifying
4
information
in
the
report
submitted
pursuant
to
paragraph
“a”
.
5
2.
The
department
shall
submit
a
report
to
the
general
6
assembly
regarding
the
efficacy
of
medical
psilocybin,
7
including
recommendations,
by
June
1,
2028.
8
Sec.
33.
NEW
SECTION
.
124F.32
Enforcement.
9
1.
If
a
person
that
is
licensed
or
registered
under
this
10
chapter
violates
a
provision
of
this
chapter
or
rules
adopted
11
by
the
department
pursuant
to
this
chapter,
or
fails
to
12
comply
with
an
enforcement
action
taken
under
this
chapter,
13
the
department
may
do
any
of
the
following,
subject
to
the
14
requirements
of
this
section:
15
a.
Revoke
the
person’s
license
or
registration
card.
16
b.
Decline
to
renew
the
person’s
license
or
registration
17
card.
18
c.
Assess
an
administrative
fee,
as
determined
by
the
19
department
by
rule.
20
2.
If
the
department
finds
that
a
person
produced
a
21
psilocybin
or
psilocybin
product
batch
that
contains
a
22
substance,
other
than
active
psilocybin,
that
poses
a
23
significant
threat
to
human
health
the
department
shall
do
all
24
of
the
following:
25
a.
Issue
the
person
a
written
administrative
citation.
26
b.
Attempt
to
negotiate
a
stipulated
settlement.
27
c.
Seize,
embargo,
or
destroy
the
psilocybin
or
psilocybin
28
product
batch.
29
d.
Order
the
person
to
cease
and
desist
from
the
action
that
30
creates
a
violation.
31
3.
The
department
may,
for
a
person
subject
to
an
32
uncontested
citation,
a
stipulated
settlement,
or
a
finding
of
33
a
violation
in
an
adjudicative
proceeding
under
this
section,
34
if
a
fine
is
not
already
specified
by
law,
assess
a
person
who
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620
is
not
an
individual
a
fine
of
up
to
five
thousand
dollars
per
1
violation.
2
4.
The
department
shall
not
revoke
a
license
or
registration
3
issued
under
this
chapter
without
first
conducting
a
contested
4
case
proceeding
pursuant
to
chapter
17A.
5
5.
Except
where
a
criminal
penalty
is
expressly
provided
for
6
a
specific
violation
of
this
chapter,
the
following
criminal
7
penalties
apply:
8
a.
Except
as
provided
in
paragraph
“b”
,
an
individual
who
9
violates
a
provision
of
this
chapter
is
guilty
of
a
simple
10
misdemeanor
punishable
by
a
fine
of
one
hundred
dollars.
11
b.
An
individual
who
intentionally
or
knowingly
violates
12
a
provision
of
this
chapter,
or
violates
a
provision
of
this
13
chapter
three
or
more
times,
is
guilty
of
a
serious
misdemeanor
14
punishable
by
a
fine
of
one
thousand
dollars.
15
EXPLANATION
16
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
17
the
explanation’s
substance
by
the
members
of
the
general
assembly.
18
This
bill
relates
to
the
production
of
psilocybin
and
19
administration
of
psilocybin
to
persons
with
post-traumatic
20
stress
disorder.
The
bill
requires
a
psilocybin
production
21
establishment
or
a
qualified
therapy
provider
location,
22
defined
in
the
bill,
to
include
an
inventory
control
system
23
that
tracks
psilocybin
product,
defined
in
the
bill,
in
24
real
time;
maintains
access
records;
and
includes
a
video
25
recording
system.
The
bill
requires
a
psilocybin
production
26
establishment
or
qualified
therapy
provider
location
to
allow
27
the
department
of
health
and
human
services
(department)
to
28
access
the
inventory
control
system
at
any
time.
29
The
bill
requires
a
state
employer
or
political
subdivision
30
employer
to
inform
an
employee
or
prospective
employee
prior
to
31
assigning
a
duty
related
to
the
administration
of
the
bill
that
32
the
employee’s
or
prospective
employee’s
job
duties
may
require
33
the
employee
or
prospective
employee
to
engage
in
conduct
in
34
violation
of
the
criminal
laws
of
the
United
States.
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The
bill
creates
within
the
department
the
psilocybin
1
production
establishment
licensing
board
(board),
with
members
2
appointed
by
the
director
of
the
department.
The
board
shall
3
consist
of
a
member
of
the
public
with
knowledge
of
psilocybin,
4
a
member
with
knowledge
and
experience
in
the
pharmaceutical
5
or
nutraceutical
manufacturing
industry,
a
member
representing
6
law
enforcement,
a
member
who
is
a
chemist
or
researcher
with
7
experience
in
manufacturing
and
who
is
associated
with
a
8
research
university,
a
member
who
has
a
background
in
fungus
or
9
mushroom
cultivation
and
processing,
and
the
director
of
the
10
department
or
the
director’s
designee,
who
shall
serve
as
the
11
chairperson
of
the
board
and
a
nonvoting
member,
except
in
the
12
case
of
a
tied
vote.
The
bill
prohibits
a
person
from
serving
13
on
the
board
if
the
person
has
certain
financial
interests
14
related
to
psilocybin.
Members
of
the
board
shall
serve
a
15
term
of
four
years,
except
that
initial
members
of
the
board
16
shall
be
appointed
for
staggered
terms
such
that
the
director
17
appoints
two
or
three
board
members
every
two
years.
The
18
director
shall
fill
vacancies
in
the
board
for
the
balance
of
19
the
unexpired
term.
Members
of
the
board
shall
serve
without
20
compensation,
although
they
may
be
reimbursed
for
actual
21
expenses,
and
the
director
may
remove
a
member
of
the
board
22
for
cause,
neglect
of
duty,
inefficiency,
or
malfeasance.
The
23
board
is
not
subject
to
automatic
dissolution
pursuant
to
Code
24
section
4A.5
(boards
and
governmental
entities
——
dissolution).
25
The
board
shall
meet
as
called
by
the
chairperson
to
review
26
psilocybin
license
applications,
conduct
public
hearings
on
27
applications,
and
make
determinations
on
license
applications.
28
The
bill
requires
the
board
to
meet
if
a
psilocybin
production
29
establishment
undergoes
certain
changes
and
annually
to
30
consider
license
renewal
applications.
The
bill
prohibits
a
31
person
from
operating
a
psilocybin
production
establishment
32
unless
the
person
holds
a
license
issued
by
the
board.
The
33
bill
requires
the
department
to
adopt
rules
for
solicitation
34
and
evaluation
of
license
applications.
The
bill
also
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requires
an
applicant
for
a
license
to
submit
the
proposed
1
name
and
address
of
the
establishment,
the
names
and
addresses
2
of
certain
persons
associated
with
the
establishment,
an
3
operating
plan,
a
statement
that
the
applicant
will
obtain
4
a
performance
bond,
an
application
fee,
and
a
description
5
of
any
investigatory
or
adverse
action
previously
taken
6
against
the
applicant
in
relation
to
any
of
the
applicant’s
7
psilocybin-related
operations
or
businesses.
The
bill
8
prohibits
a
psilocybin
production
establishment
from
operating
9
within
1,000
feet
of
a
community
location,
defined
in
the
bill,
10
or
500
feet
of
an
area
that
is
zoned
as
primarily
residential.
11
The
bill
allows
the
board
to
waive
these
limitations
by
up
to
12
20
percent.
13
Upon
approval
of
an
application
for
a
license,
the
bill
14
requires
the
applicant
to
pay
an
initial
licensing
fee
and
the
15
department
to
inform
the
department
of
public
safety.
The
bill
16
allows
a
psilocybin
production
establishment
to
be
located
17
at
the
same
location
as
a
medical
cannabidiol
producer
and
18
the
board
may
grant
preference
to
an
applicant
who
currently
19
holds
a
medical
cannabidiol
producer
license.
If
the
board
20
receives
more
than
one
application
for
a
psilocybin
production
21
establishment
license
in
the
same
city
or
town,
the
board
22
shall
consult
with
the
local
land
use
authority
prior
to
23
issuing
a
license.
The
bill
prohibits
the
board
from
issuing
24
a
license
to
certain
persons.
The
bill
allows
the
board
to
25
revoke
a
license
for
certain
violations.
Fees
collected
by
26
the
department
shall
be
deposited
into
the
general
fund
of
the
27
state.
28
If
the
municipality
or
county
where
the
psilocybin
29
production
establishment
will
be
located
requires
a
land
use
30
permit,
the
bill
requires
a
licensee
to
submit
a
copy
of
an
31
approved
land
use
permit
within
120
days
of
issuance
of
the
32
license.
The
bill
prohibits
the
board
from
issuing
more
than
33
four
licenses
to
operate
an
independent
psilocybin
testing
34
laboratory
and
allows
the
board
to
operate
an
independent
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psilocybin
testing
laboratory.
A
psilocybin
production
1
establishment
is
not
transferable
or
assignable,
and
the
2
board’s
authority
to
issue
a
license
is
plenary
and
not
3
subject
to
review.
The
bill
requires
the
division
of
criminal
4
investigation
of
the
department
of
public
safety
to
conduct
5
a
thorough
investigation
of
each
applicant
for
a
psilocybin
6
production
establishment
license.
The
bill
requires
the
board
7
to
begin
accepting
license
applications
on
July
1,
2026.
The
8
board
shall
renew
a
license
if
the
licensee
continues
to
meet
9
the
requirements
for
initial
licensure,
the
board
does
not
10
identify
a
significant
failure
of
compliance
or
grounds
for
11
revocation,
and
the
licensee
pays
a
renewal
fee.
12
The
bill
requires
a
person
applying
for
a
psilocybin
13
production
establishment
license
or
license
renewal
to
submit
a
14
proposed
operating
plan,
including
certain
information
about
15
the
facility,
the
facility’s
officers
and
employees,
a
security
16
plan,
a
description
of
the
inventory
control
system,
and
17
storage
protocols.
The
bill
requires
psilocybin
cultivation
18
facilities
and
psilocybin
testing
laboratories
to
submit
19
additional
information
particular
to
the
type
of
psilocybin
20
production
establishment.
21
The
bill
prohibits
a
person
from
acting
as
a
psilocybin
22
production
establishment
or
qualified
therapy
provider
agent
23
unless
the
person
is
registered
as
a
psilocybin
production
24
establishment
agent
with
the
board.
The
bill
prohibits
certain
25
persons
from
acting
as
a
psilocybin
production
establishment
26
agent.
The
bill
requires
the
board
to
issue
a
psilocybin
27
production
establishment
agent
registration
to
a
person
if
28
the
psilocybin
production
establishment
that
will
employ
29
the
agent
submits
an
application
and
pays
a
fee
on
behalf
30
of
the
person.
The
prospective
agent
shall
also
undergo
a
31
criminal
background
investigation.
A
psilocybin
production
32
establishment
agent
shall
comply
with
a
certification
standard
33
adopted
by
the
board.
A
psilocybin
production
establishment
34
agent
registration
is
valid
for
two
years
and
may
be
renewed.
35
-38-
LSB
1463HH
(6)
91
ss/ko
38/
45
H.F.
620
The
bill
requires
a
psilocybin
production
establishment
agent
1
to
carry
the
agent’s
registration
card
at
all
times
while
on
2
the
premises
of
the
psilocybin
production
establishment
or
when
3
transporting
psilocybin.
There
is
a
rebuttable
presumption
a
4
person
carrying
a
psilocybin
production
establishment
agent
5
registration
card
while
in
possession
of
psilocybin
possesses
6
the
psilocybin
legally.
A
psilocybin
production
establishment
7
agent
who
fails
to
carry
a
psilocybin
production
establishment
8
agent
registration
card
while
required
to
do
so
is
guilty
of
a
9
simple
misdemeanor
punishable
by
a
fine
of
$100
for
a
first
or
10
second
offense
in
a
two-year
period
and
a
simple
misdemeanor
11
punishable
as
provided
by
law
for
a
third
or
subsequent
offense
12
in
a
two-year
period.
A
simple
misdemeanor
is
punishable
by
13
confinement
for
no
more
than
30
days
and
a
fine
of
at
least
14
$105
but
not
more
than
$855.
The
board
may
fine
a
psilocybin
15
production
establishment
or
qualified
therapy
provider
that
16
employs
a
psilocybin
production
establishment
agent
a
fine
for
17
each
violation.
18
The
bill
requires
a
psilocybin
production
establishment
19
to
operate
in
accordance
with
the
operating
plan
submitted
20
by
the
psilocybin
production
establishment
and
to
inform
the
21
department
prior
to
implementing
any
changes
to
the
plan.
22
The
bill
requires
a
psilocybin
production
establishment
to
23
operate
in
a
facility
that
is
accessible
only
by
an
individual
24
with
a
valid
psilocybin
production
establishment
registration
25
card,
except
that
a
psilocybin
production
establishment
may
26
authorize
a
person
who
is
at
least
18
years
of
age
who
is
27
not
a
psilocybin
production
establishment
agent
to
access
28
the
psilocybin
production
establishment
if
the
psilocybin
29
production
establishment
tracks
and
monitors
the
individual
at
30
all
times.
A
psilocybin
production
establishment
shall
not
31
employ
a
person
who
is
under
21
years
of
age
or
who
has
been
32
convicted
of
a
misdemeanor
for
drug
distribution
or
any
felony.
33
The
bill
requires
a
psilocybin
production
establishment
to
have
34
a
single,
secure
public
entrance
and
a
security
system
with
a
35
-39-
LSB
1463HH
(6)
91
ss/ko
39/
45
H.F.
620
backup
power
source.
1
The
bill
allows
the
department
to
inspect
the
facility
and
2
records
of
a
psilocybin
production
establishment
at
any
time
3
during
business
hours.
The
bill
grants
certain
investigational
4
powers
to
the
department
and
allows
the
department
to
impose
5
a
fee
or
suspend
or
revoke
a
license
or
registration
for
6
failing
to
comply
with
an
inspection.
The
bill
prohibits
a
7
psilocybin
production
establishment
from
advertising
to
the
8
general
public,
except
to
advertise
an
employment
opportunity.
9
The
bill
requires
the
department
to
adopt
rules
for
standards
10
relating
to
advertisement
by
qualified
medical
psilocybin
11
providers
and
qualified
medical
psilocybin
therapists,
defined
12
in
the
bill.
13
The
bill
prohibits
a
person
other
than
a
psilocybin
14
production
establishment
agent,
qualified
therapy
provider,
15
qualified
therapy
provider
agent,
or
an
agent
of
the
department
16
conducting
an
inspection
from
transporting
psilocybin.
A
17
person
transporting
psilocybin
must
possess
a
manifest
18
including
details
about
the
psilocybin
the
person
has
been
19
authorized
to
transport.
A
psilocybin
production
establishment
20
agent
who
transports
psilocybin
without
a
manifest
is
guilty
21
of
a
simple
misdemeanor
punishable
by
a
fine
of
$100.
A
22
psilocybin
production
establishment
who
transports
an
amount
of
23
psilocybin
in
excess
of
the
amount
indicated
in
the
manifest
24
is
subject
to
penalties
as
provided
in
Code
chapter
124
25
(controlled
substances).
The
bill
requires
a
person
disposing
26
of
psilocybin
waste
to
render
the
psilocybin
waste
unusable
27
and
unrecognizable
and
to
dispose
of
it
in
compliance
with
28
applicable
state
and
federal
law.
29
The
bill
requires
a
local
government
to
allow
a
psilocybin
30
production
establishment
to
operate
in
any
zone
designated
for
31
industrial
or
agricultural
use,
unless
the
local
government
has
32
designated
at
least
one
industrial
or
agricultural
zone
for
the
33
operation
of
a
psilocybin
production
establishment
prior
to
the
34
receipt
of
an
application
for
the
establishment
of
a
psilocybin
35
-40-
LSB
1463HH
(6)
91
ss/ko
40/
45
H.F.
620
production
establishment
by
the
local
government.
The
bill
1
allows
a
psilocybin
production
establishment
to
operate
on
land
2
that
has
not
been
zoned.
The
bill
prohibits
local
governments
3
from
imposing
certain
restrictions
on
the
establishment
of
a
4
psilocybin
production
establishment.
5
The
bill
requires
a
psilocybin
cultivation
facility
to
6
use
unique
identifiers
to
identify
certain
classifications
7
of
psilocybin.
The
bill
prohibits
a
psilocybin
cultivation
8
facility
from
selling
any
product
other
than
a
psilocybin
9
product
or
educational
material
related
to
psilocybin
and
from
10
selling
to
a
person
other
than
a
qualified
therapy
provider
or
11
a
registered
agent
of
a
qualified
therapy
provider.
The
bill
12
includes
certain
labeling
requirements
for
psilocybin
products.
13
The
bill
requires
the
department
to
adopt
rules
for
the
14
testing
of
psilocybin
by
an
independent
psilocybin
testing
15
laboratory.
The
bill
allows
the
department
to
require
an
16
independent
psilocybin
testing
laboratory
to
test
for
a
toxin
17
if
the
department
receives
information
about
the
presence
18
of
the
toxin.
The
bill
prohibits
a
psilocybin
production
19
establishment
from
transferring
psilocybin
to
a
qualified
20
therapy
provider
until
a
sample
of
the
psilocybin
has
been
21
tested
by
an
independent
psilocybin
testing
laboratory.
The
22
bill
allows
the
department
to
require
an
independent
psilocybin
23
testing
laboratory
to
participate
in
a
proficiency
evaluation.
24
If
an
independent
psilocybin
testing
laboratory
determines
that
25
a
psilocybin
product
is
unsafe
for
human
use,
the
bill
requires
26
the
independent
psilocybin
testing
laboratory
to
inform
the
27
department
and
the
psilocybin
cultivation
facility
from
which
28
the
batch
originated,
and
the
department
shall
place
a
hold
on
29
the
sale
and
use
of
the
psilocybin
product
until
the
department
30
completes
an
investigation.
31
The
bill
requires
the
department,
in
consultation
with
the
32
departments
of
agriculture
and
public
safety,
to
adopt
rules
33
for
the
creation
and
operation
of
an
electronic
verification
34
system.
The
electronic
verification
system
shall,
at
a
35
-41-
LSB
1463HH
(6)
91
ss/ko
41/
45
H.F.
620
minimum,
allow
a
medical
psilocybin
provider
to
engage
in
1
patient
management;
allow
access
by
the
department
and
the
2
department
of
inspections,
appeals,
and
licensing;
create
a
3
record
each
time
a
person
accesses
the
system;
and
keeps
a
4
current
record
of
the
total
number
of
individuals
who
have
a
5
psilocybin
recommendation.
The
bill
allows
the
department
to
6
release
limited
data
from
the
electronic
verification
system
7
for
research,
reporting,
and
official
department
purposes.
A
8
person
who
knowingly
and
intentionally
releases
information
9
from
the
electronic
verification
system
in
violation
of
the
10
bill
is
guilty
of
class
“D”
felony.
A
class
“D”
felony
is
11
punishable
by
confinement
for
no
more
than
five
years
and
a
12
fine
of
at
least
$1,025
but
not
more
than
$10,245.
A
person
13
who
negligently
or
recklessly
releases
information
from
the
14
electronic
verification
system
in
violation
of
the
bill
is
15
guilty
of
a
serious
misdemeanor.
A
serious
misdemeanor
is
16
punishable
by
confinement
for
no
more
than
one
year
and
a
17
fine
of
at
least
$430
but
not
more
than
$2,560.
A
person
who
18
unlawfully
obtains
or
attempts
to
obtain
information
from
the
19
electronic
verification
system
is
guilty
of
a
class
“D”
felony.
20
The
bill
limits
the
number
of
psilocybin
recommendations
21
in
the
state
to
5,000
patients.
An
individual’s
psilocybin
22
recommendation
expires
if
the
individual
has
not
received
23
treatment
from
a
qualified
therapy
provider
with
psilocybin
24
or
a
psilocybin
product
by
the
later
of
one
year
from
the
25
day
a
qualified
medical
psilocybin
provider
provided
the
26
recommendation
or
one
year
from
the
day
of
the
individual’s
27
most
recent
administration
of
psilocybin
or
a
psilocybin
28
product
by
a
qualified
therapy
provider.
The
bill
prohibits
29
a
person
from
recommending
the
use
of
psilocybin
unless
the
30
person
is
a
qualified
medical
psilocybin
provider,
defined
in
31
the
bill
as
a
physician
and
surgeon
or
osteopathic
physician
32
and
surgeon,
a
physician
assistant,
an
advanced
registered
33
nurse
practitioner,
or
an
advanced
practice
registered
nurse
34
who
is
registered
by
the
department
to
recommend
treatment
35
-42-
LSB
1463HH
(6)
91
ss/ko
42/
45
H.F.
620
with
psilocybin.
The
bill
requires
the
department
to
issue
a
1
qualified
medical
psilocybin
provider
registration
card
to
an
2
individual
if
the
individual
submits
an
application,
provides
3
a
report
detailing
the
completion
of
continuing
education
4
requirements
regarding
the
use
of
psilocybin
listed
in
the
5
bill,
provides
evidence
that
the
person
holds
an
appropriate
6
license,
and
pays
an
application
fee.
7
The
bill
prohibits
a
qualified
medical
psilocybin
provider
8
from
recommending
the
use
of
psilocybin
unless
the
qualified
9
medical
psilocybin
provider
completes
a
thorough
assessment
10
of
the
patient’s
condition
and
history,
verifies
that
the
11
patient
has
post-traumatic
stress
disorder,
verifies
that
the
12
patient
is
at
least
21
years
old,
and
meets
with
the
patient
13
in
person
if
the
qualified
medical
psilocybin
provider
has
not
14
previously
recommended
a
psilocybin
treatment
to
the
patient.
15
The
bill
places
restrictions
on
advertisements
by
qualified
16
medical
psilocybin
providers.
A
qualified
medical
psilocybin
17
provider
registration
card
expires
after
two
years
and
may
be
18
renewed.
The
bill
allows
the
department
to
revoke
a
qualified
19
medical
psilocybin
provider
registration
card
for
failure
20
to
comply
with
the
bill.
The
bill
prohibits
a
qualified
21
medical
psilocybin
provider
from
receiving
compensation
from
22
certain
persons
involved
in
the
production
of
psilocybin.
A
23
qualified
medical
psilocybin
provider
shall
not
be
subject
to
a
24
professional,
civil,
or
criminal
penalty
solely
for
violating
25
a
federal
law
or
regulation
that
would
prohibit
recommending,
26
prescribing,
possessing,
or
dispensing
psilocybin.
27
The
bill
prohibits
discrimination
against
a
person
in
28
the
provision
of
medical
care,
including
organ
or
tissue
29
transplantation,
on
the
basis
of
the
usage
of
psilocybin
as
30
provided
in
the
bill.
The
bill
also
prohibits
the
state
or
a
31
political
subdivision
of
the
state
from
discriminating
against
32
an
employee
on
the
basis
of
the
employee’s
use
of
psilocybin
33
as
provided
in
the
bill
except
under
certain
circumstances,
as
34
provided
in
the
bill.
35
-43-
LSB
1463HH
(6)
91
ss/ko
43/
45
H.F.
620
The
bill
does
not
require
an
insurer,
a
third-party
1
administrator,
or
an
employer
to
pay
or
reimburse
for
2
psilocybin.
The
bill
does
not
restrict
the
prescription,
3
distribution,
or
dispensing
of
a
product
that
the
United
States
4
food
and
drug
administration
has
approved.
5
The
bill
prohibits
a
person
from
administering
a
psilocybin
6
treatment
unless
the
department
registers
the
person
as
a
7
qualified
medical
psilocybin
therapist,
defined
in
the
bill
as
8
a
physician
and
surgeon
or
osteopathic
physician
and
surgeon,
a
9
physician
assistant,
an
advanced
registered
nurse
practitioner,
10
an
advanced
practice
registered
nurse,
a
psychologist,
or
a
11
social
worker.
The
department
shall
register
a
person
as
a
12
qualified
medical
psilocybin
therapist
if
the
person
submits
13
an
application,
provides
the
address
of
the
clinic
where
14
psilocybin
will
be
administered,
provides
a
report
detailing
15
the
completion
of
continuing
education
requirements
regarding
16
the
use
of
psilocybin
listed
in
the
bill,
certifies
that
the
17
individual
has
an
inventory
control
system,
provides
evidence
18
that
person
has
an
appropriate
license,
pays
an
application
19
fee,
and
provides
an
emergency
transport
plan.
A
qualified
20
medical
psilocybin
therapist
shall
not
administer
psilocybin
21
to
a
patient
unless
the
patient
has
a
recommendation
issued
22
by
a
qualified
medical
psilocybin
provider,
the
qualified
23
medical
psilocybin
therapist
has
reviewed
the
patient’s
mental
24
health
history,
the
qualified
medical
psilocybin
therapist
25
has
provided
the
patient
with
a
safety
sheet
created
by
the
26
department,
there
are
unexpired
rescue
medications
on
site,
the
27
administration
session
is
video-recorded,
and
the
qualified
28
medical
psilocybin
therapist
has
a
contractual
relationship
29
with
a
licensed
physician
and
surgeon
or
osteopathic
physician
30
and
surgeon
who
remains
on
call
during
the
course
of
the
31
administration
session
in
case
a
patient
requires
nonemergency
32
medical
intervention.
33
A
qualified
therapy
provider
shall
only
administer
34
psilocybin
in
a
qualified
therapy
provider
location.
The
bill
35
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H.F.
620
places
limits
on
advertising
by
qualified
therapy
providers.
A
1
qualified
therapy
provider
registration
expires
after
two
years
2
and
may
be
renewed.
The
bill
requires
a
qualified
therapy
3
provider
to
submit
a
report
to
the
department
within
seven
days
4
after
the
occurrence
of
an
adverse
event,
defined
in
the
bill.
5
The
bill
allows
the
department
to
revoke
a
qualified
therapy
6
provider
registration
if
a
qualified
therapy
provider
fails
to
7
maintain
compliance
with
the
requirements
of
the
bill.
8
The
bill
requires
the
department
to
submit
a
report
to
the
9
general
assembly
on
or
before
November
1,
2025,
and
annually
by
10
November
1
thereafter,
regarding
participation
in
the
medical
11
psilocybin
program.
The
bill
also
requires
the
department
to
12
submit
a
report
regarding
the
medical
efficacy
of
psilocybin
13
to
the
general
assembly,
including
recommendations,
by
June
1,
14
2028.
15
The
bill
grants
the
department
enforcement
authority
for
the
16
enforcement
of
the
bill,
including
by
disciplining
licenses
17
and
registrations,
imposing
fees,
and
seizing
and
destroying
18
psilocybin.
The
department
shall
not
revoke
a
license
or
19
registration
issued
pursuant
to
the
bill
without
first
20
conducting
a
contested
case
proceeding.
21
A
person
who
violates
a
provision
of
the
bill
for
which
22
another
penalty
is
not
provided
is
guilty
of
a
simple
23
misdemeanor
punishable
by
a
fine
of
$100,
except
that
a
person
24
who
intentionally
or
knowingly
violates
a
provision
of
the
bill
25
for
which
no
other
penalty
is
provided
three
or
more
times
is
26
guilty
of
a
serious
misdemeanor
punishable
by
a
fine
of
$1,000.
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