On September 29, 2017, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register removing naldemedine from the federal Controlled Substances Act.
Plain language analysis:
The Controlled Substances Board did not receive an objection to excluding naldemedine as a controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on November 10, 2017 to similarly treat naldemedine under chapter 961 effective November 20, 2017 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule. This rule amends s. 961.16 (2) (a) (intro.), Stats. which excludes naldemedine from the controlled substance schedules. Comparison with rules in adjacent states:
Illinois: Illinois has not excluded naldemedine from scheduling.
Iowa: Iowa has not excluded naldemedine from scheduling.
Michigan: Michigan has not excluded naldemedine from scheduling.
Minnesota: Minnesota has not excluded naldemedine from scheduling.
Summary of factual data and analytical methodologies:
The methodology was to exclude naldemedine 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 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:
Sharon Henes, 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. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 2.58 is created 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, naldemedine, 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:
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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Dated _May 10, 2019____ 
Chair Controlled Substances Board
