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.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule schedules a drug and does not have an effect on small business.
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 Kirsten.Reader@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@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 Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received by April 26, 2017 to be included in the record of rule-making proceedings. TEXT OF RULE
Section 1. CSB 2.48 is created to read:
CSB 2.48 Addition of eluxadoline to schedule IV. Section 961.20 (4) (cm), Stats., is created to read: 961.20 (4) (cm) Eluxadoline, including any of its isomers, and salts of isomers.
Section 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. (END OF TEXT OF RULE)
