STATE OF WISCONSIN
CONTROLLED SUBSTANCES BOARD
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IN THE MATTER OF RULE-MAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : CONTROLLED SUBSTANCES
CONTROLLED SUBSTANCES BOARD : BOARD
: ADOPTING RULES
: (CLEARINGHOUSE RULE 22-035)
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ORDER
An order of the Controlled Substances Board to create CSB 2.85 relating to Excluding 6-beta-Naltrexol.
Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted: s. 961.16, Stats. Explanation of agency authority:
Section 961.11 (1), Stats. provides that “[t]he 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 rule-making procedures of ch. 227.” Section 961.11(4), Stats. provides that “[i]f 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).” Related statute or rule: s. 961.16, Stats. Plain language analysis:
This rule excludes 6-beta-Naltrexol from schedule II.
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:
