Statement of Scope
CONTROLLED SUBSTANCES BOARD
Relating to
:
|
Removing
[
123
I]
ioflupane
as a controlled substance
|
1.
Finding/nature of emergency (Emergency Rule only):
N/A
2
.
Detailed description of the objective of the
proposed
rule
:
The objective of the proposed rule is
exclude
[
123
I
]
ioflupane
as a controlled substance
3
.
Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives
:
On
September 11
, 2015
, the
U.S. Department of Justice
, Drug Enforcement Administration published its final rule in the Federal Register
removing
[
123
I
]
ioflupane
from
the federal Controlled Substances Act. The scheduling action was effective
September 11
, 2015
. The Controlled Substances Board did not receive
an objection to similarly remove
[
123
I
]
ioflupane
from schedule II
under
ch.
961
, Stats within 30 days of the date of publication in the federal register of the final order
removing
[
123
I]
ioflupane
as a controlled substance.
Pursuant to s.
961.11(4)
, Stats, the Controlled Substances Board took affirmative action to similarly treat
[
123
I
]
ioflupane
under chapter 961, Stats.
by
creating the following:
CSB 2.
40
Exclusion
of
[
123
I
]
ioflupane
.
961.16(2
)
(
b)
Coca leaves and any salt, compound, derivative or preparation of coca leaves.
Decocainized
coca leaves or extractions which do not contain cocaine or
ecgonine
are excluded from this paragraph. [
123
I
]
ioflupane
is excluded from this paragraph. The following substances and any of their salts, esters, isomers and salts of esters and isomers that are theoretically possible within the specific chemical
designation,
are included in this paragraph.
The Affirmative Action order
, dated
October 13
, 2015
,
took
effect on
October 19
, 2015
to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4
.
Detailed explanation of statutory authority for the rule
(including
the
statutory citation and language):
961.11(2)
After considering the factors enumerated in sub. (1m), the
controlled substances board shall make findings with respect to
them and promulgate a rule controlling the substance upon finding
that the substance has a potential for abuse.
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
d
esignating 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).
5
.
Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule
:
25 hours
6
.
List with description of all entities that
may
be affected by the proposed rule
:
P
harmacists, prescribers, courts, police and
the
Controlled Substances Board
7
.
Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule
:
On
September 11
, 2015
, the United States
Department of Justice
, Drug Enforcement Administration published its final rule in the Federal Register
removing
[
123
I
]
ioflupane
from
schedule II
of the federal Controlled Substances Act. The scheduling action was effective
September 11
, 2015
.
8
.
Anticipated economic impact of
implementing the rule
(note if the rule is likely to have a significant economic impact on small businesses
)
:
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person:
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Chair
Date Submitted