STATE OF
WISCONSIN
CONTROLLED SUBSTANCES
BOARD
---------------------------------------------------------------------------------------------------------------------
IN
THE MATTER
OF
RULE-MAKING
:
PROPOSED ORDER
OF
THE
PROCEEDINGS
BEFORE THE
:
CONTROLLED SUBSTANCES
BOARD
CONTROLLED SUBSTANCES
BOARD
:
ADOPTING RULES
:
(CLEARINGHOUSE
RULE
)
---------------------------------------------------------------------------------------------------------------------
PROPOSED ORDER
An
order
of
the
Controlled
Substances
Board
to
create
CSB
2.39
relating
to
exclusion of
naloxegol
.
Analysis
prepared
by
the
Department
of
Safety
and
Professional
Services.
---------------------------------------------------------------------------------------------------------------------
ANALYSIS
Statutes
interpreted:
s.
961.20
,
Stats.
Explanation
of
agency
authority:
961.11(4)
If
a
substance
is
designated,
rescheduled
or
deleted
as
a
controlled
substance
under
federal
law and
notice
thereof
is
given
to the
controlled
substances
board, the
board
by
affirmative
action
shall
similarly
treat
the
substance under
this
chapter after
the
expiration
of
30
days
from
the
date
of
publication in the
federal
register
of
a
final
order
designating
the
substance
as
a
controlled
substance
or
rescheduling
or
deleting
the
substance
or
from
the
date
of
issuance
of
an
order
of
temporary
scheduling
under
21 USC 811
(h),
unless
within
that
30−day
period, the
board
or
an
interested
party
objects
to the
treatment of
the
substance.
If
no objection is
made,
the
board
shall
promulgate,
without
making
the
determinations or
findings
required
by
subs.
(1),
(1m),
(1r)
and
(2)
or
s.
961.13
,
961.15
,
961.17
,
961.19
or
961.21
, a
final
rule,
for which
notice
of
proposed
rulemaking
is omitted,
designating,
rescheduling,
temporarily
scheduling
or
deleting
the
substance.
If
an
objection is
made
the
board
shall publish
notice
of
receipt
of
the
objection
and
the
reasons
for
objection
and
afford
all
interested
parties
an
opportunity
to be
heard.
At
the
conclusion
of
the
hearing, the
board
shall
make
a
determination
with
respect
to the
treatment
of
the
substance as
provided in subs.
(1),
(1m),
(1r)
and
(2) and
shall publish its
decision,
which
shall
be
final
unless
altered
by
statute.
Upon
publication
of
an
objection
to
the
treatment
by
the
board,
action
by
the
board
under
this
chapter
is
stayed
until the
board
promulgates
a
rule
under
sub.
(2).
Related
statute
or
rule:
N/A
Summary
of, and
comparison
with,
existing
or
proposed
federal
regulation:
On
January
23, 2015, the
United
States
Department
of
Justice,
Drug
Enforcement
Administration
published
its
final
rule
in the
Federal
Register
removing
naloxegol
from schedule
II
of
the
federal
Controlled
Substances
Act.
The
scheduling
action
was
effective
January
23, 2015.
Plain
language
analysis:
The Controlled
Substances
Board
did not
receive
an
objection
to excluding
naloxegol
as
a
schedule
II
under
ch.
961
,
Stats.
based
upon the
federal
scheduling.
The
Controlled
Substances
Board
took
affirmative
action on
March
25, 2015
to similarly
exclude
naloxegol
under chapter
961
effective April
1, 2015 to
allow for
publication in the
Administrative Register.
The
Affirmative
Action
Order will
expire
upon
promulgation
of
a
final
rule.
This
rule amends
961.16(2
)(
a)(intro),
Stats.
which
excludes
naloxegol
from
schedule
II.
Comparison
with
rules
in
adjacent states:
Illinois
:
Illinois
does
not exclude
naloxegol
from
scheduling.
Iowa
:
Iowa
does
not exclude
naloxegol
from
scheduling.
Michigan
:
Michigan
does not exclude
naloxegol
from
scheduling.
Minnesota:
Minnesota
has
a
bill to exclude
naloxegol
from
scheduling.
Summary
of
factual
data
and
analytical
methodologies:
The
methodology
was to
remove
naloxegol
from
scheduling
to
conform
with
the
federal
Controlled
Substances
Act.
Analysis
and
supporting
documents
used
to
determine effect
on
small
business
or
in
preparation
of
economic impact
analysis:
This
rule was
posted
for
14
days
for
economic
comments
and
none
were received.
Fiscal
Estimate
and
Economic Impact Analysis:
The Fiscal
Estimate and
Economic
Impact
Analysis
is
attached.
Effect
on
small
business
:
These proposed
rules
do
not
have an
economic
impact
on
small
businesses,
as
defined
in s.
227.114
(1),
Stats.
The
Department’s
Regulatory
Review Coordinator
may
be
contacted
by
email
at
Eric.Esser@wisconsin.gov
,
or
by
calling
(608) 267-2435.
Agency
contact person
:
Sharon
Henes
,
Administrative Rules
Coordinator,
Department
of
Safety
and
Professional
Services,
Division
of
Board
Services,
1400
East
Washington
Avenue,
Room 151,
P.O.
Box
8366,
Madison,
Wisconsin
53708;
telephone
608-261-2377;
email
at
Sharon.Henes@wisconsin.gov
.
Place where comments
are to
be
submitted
and
deadline
for
submission
:
Comments
may
be
submitted
to
Sharon
Henes
,
Administrative Rules
Coordinator,
Department
of
Safety
and
Professional
Services,
Division
of
Board
Services,
1400
East
Washington
Avenue,
Room 151,
P.O.
Box
8366,
Madison,
WI
53708-8935, or
by
email
to
Sharon.Henes@wisconsin.gov
.
Comments
must be
received
on or
before
October
2, 2015 to be
included
in the
record
of
rule-making
proceedings.
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TEXT OF
RULE
S
ECTION
1.
CSB
2.39
is
created
to
read:
CSB
2.39
Exclusion
of
naloxegol
.
Section
961.16(2
)(
a)(intro)
,
Stats.,
is
amended
to
read:
961.16(2)(a)(intro) Opium
and
substances
derived
from
opium,
and any
salt,
compound,
derivative
or
preparation
of opium
or
substances
derived
from
opium.
Apomorphine
,
dextrorphan
,
nalbuphine
,
butorphanol
,
nalmefene
,
naloxegol
,
naloxone
and
naltrexone
and
their
respective
salts and the
isoquinoline
alkaloids
of
opium
and
their
respective
salts are
excluded
from
this paragraph.
The
following
substances,
and any
of
their
salts,
isomers
and salts of
isomers
that are
theoretically
possible
within
the
specific chemical
designation, are
included
in
this paragraph:
S
ECTION
2.
EFFECTIVE DATE.
The
rules
adopted in
this
order shall
take
effect
on the
first
day
of
the
month
following
publication
in the
Wisconsin
administrative register,
pursuant
to s.
227.22
(2) (intro.),
Stats.
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(END
OF
TEXT
OF
RULE)
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