The Controlled Substances Board did not receive an objection to similarly removing 6-beta-Naltrexol as a schedule II controlled substance under ch. 961, Stats. within 30 days of the date of publication in the federal register of the final order removing 6-beta-Naltrexol as a schedule II controlled substance. Pursuant to s. 961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat 6-beta-Naltrexol under ch. 961, Stats. by creating the following: CSB 2.85 Excluding 6-beta-Naltrexol from schedule II. Section 961.16 (2) (a), Stats., is amended to read:
961.16 (2) (a) 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, 6-beta-naltrexol, 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:
The Affirmative Action order, dated July 9, 2021, took effect on July 19, 2021 to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
Summary of, and comparison with, existing or proposed federal regulation:
On January 24, 2020, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register removing 6-beta-Naltrexol from schedule II of the federal Controlled Substances Act. The scheduling action is effective January 24, 2020.
Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A
Comparison with rules in adjacent states:
Illinois: Illinois has not excluded 6-beta-naltrexol from their schedule II controlled substances list.
Iowa: Iowa has excluded 6-beta-naltrexol from their schedule II controlled substances list [Iowa Administrative Code s. 124.206 (2) (a)]. Michigan: Michigan has not excluded 6-beta-naltrexol from their schedule II controlled substances list.
Minnesota: Minnesota has not excluded 6-beta-naltrexol from their schedule II controlled substances list.
Summary of factual data and analytical methodologies:
This rule excludes 6-beta-Naltrexol from schedule II 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 report:
The proposed rules were posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No comments were received.
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 Jennifer.Garrett@wisconsin.gov, or by calling (608) 266-6795. Agency contact person:
Nilajah Hardin, 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 608-267-7139; email at DSPSAdminRules@wisconsin.gov. ------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 2.85 is created to read:
CSB 2.85 Excluding 6-beta-Naltrexol from schedule II. Section 961.16 (2) (a), Stats., is amended to read:
961.16 (2) (a) 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, 6-beta-naltrexol, 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 _________________ Agency __________________________________
Chairperson
Controlled Substances Board
