STATE OF WISCONSIN
Controlled Substances Board
IN THE MATTER OF RULE-MAKING PROCEEDINGS BEFORE THE
CONTROLLED SUBSTANCES BOARD
PROPOSED ORDER OF THE CONTROLLED SUBSTANCES BOARD
(CLEARINGHOUSE RULE )
An order of the Controlled Substances Board to create CSB 2.48 relating to scheduling of eluxadoline.
Analysis prepared by the Department of Safety and Professional Services.
Statutes interpreted: s. 961.20, Stats.
Explanation of agency authority:
The controlled substances board shall administer this subchapter and may add substances to or delete or reschedule all substances listed in the schedules in ss. 961.14, 961.16, 961.18, 961.20 and 961.22 pursuant to the rulemaking procedures of ch. 227. [s. 961.11 (1), Stats.] 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). [s. 961.11(4), Stats.] Related statute or rule: s. 961.20, Stats.
Summary of, and comparison with, existing or proposed federal regulation:
On November 12, 2015, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing eluxadoline into Schedule IV of the federal Controlled Substances Act.
Plain language analysis:
The Controlled Substances Board did not receive an objection to treating eluxadoline as a schedule IV controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on November 15, 2016 to similarly treat eluxadoline under chapter 961 effective November 21, 2016 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule. This rule creates s. 961.20 (4) (cm), Stats. which adds eluxadoline to schedule IV.
Comparison with rules in adjacent states:
Illinois: Illinois has scheduled eluxadoline as a schedule IV controlled substance.
Iowa: Iowa is in the process of scheduling eluxadoline.
Michigan: Michigan has not scheduled eluxadoline.
Minnesota: Minnesota has scheduled eluxadoline as a schedule IV controlled substance.
Summary of factual data and analytical methodologies:
The methodology was to schedule eluxadoline to conform with the federal Controlled Substances Act.