On April 7, 2020, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing lemborexant into Schedule IV of the federal Controlled Substances Act.
Plain language analysis:
The Controlled Substances Board did not receive an objection to treating lemborexant as a schedule IV controlled substance under ch. 961, Stats., based upon the federal scheduling. The Controlled Substances Board took affirmative action on May 8, 2020 to similarly treat lemborexant under chapter 961 effective May 18, 2020 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 (2) (eqm), Stats., which adds lemborexant to schedule IV. Comparison with rules in adjacent states:
Illinois: Illinois has not scheduled lemborexant.
Iowa: Iowa has not scheduled lemborexant.
Michigan: Michigan has not scheduled lemborexant.
Minnesota: Minnesota has not scheduled lemborexant.
Summary of factual data and analytical methodologies:
The methodology was to schedule lemborexant 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 Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Jon Derenne, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, 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 Jon Derenne, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received by January 14, 2021 to be included in the record of rule-making proceedings. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 2.74 is created to read:
CSB 2.74 Addition of Lemborexant to schedule IV. Section 961.20 (2) (eqm), Stats., is created to read:
961.20 (2) (eqm) Lemborexant.
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)
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