CR 20-049 Rule Text

STATE OF WISCONSIN

CONTROLLED SUBSTANCES BOARD

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IN THE MATTER OF RULE-MAKING   :   ORDER OF THE

PROCEEDINGS BEFORE THE     :   CONTROLLED SUBSTANCES BOARD

CONTROLLED SUBSTANCES BOARD   :   ADOPTING RULES

            :   (CLEARINGHOUSE RULE 20-049)

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PROPOSED ORDER

An order of the Controlled Substances Board to create CSB 2.67 relating to scheduling of brexanolone and solriamfetol.

Analysis prepared by the Department of Safety and Professional Services.

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ANALYSIS

Statutes interpreted: s. 961.20, Stats.

Statutory authority: ss. 961.11 (1) and (4), Stats.

Explanation of agency authority:

The 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. [s. 961.11 (1), Stats.]

If 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). [s. 961.11 (4), Stats.]

Related statute or rule: s. 961.20, Stats.

Summary of, and comparison with, existing or proposed federal regulation:

On June 17, 2019, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing brexanolone and solriamfetol into Schedule IV of the federal Controlled Substances Act.

Plain language analysis:

The Controlled Substances Board did not receive an objection to treating brexanolone and solriamfetol as schedule IV controlled substances under ch. 961, Stats., based upon the federal scheduling. The Controlled Substances Board took affirmative action on July 17, 2019 to similarly treat brexanolone and solriamfetol under chapter 961 effective July 22, 2019 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) (ap) and (2m) (g), Stats. which adds brexanolone and solriamfetol to schedule IV.

Comparison with rules in adjacent states:

Illinois: Illinois has not scheduled brexanolone or solriamfetol.

Iowa: Iowa has scheduled brexanolone and solriamfetol as Schedule IV controlled substances.

Michigan: Michigan has not scheduled brexanolone or solriamfetol.

Minnesota: Minnesota has not scheduled brexanolone or solriamfetol.

Summary of factual data and analytical methodologies:

The methodology was to schedule brexanolone and solriamfetol 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 drugs and does not have an effect on small business.

Fiscal Estimate and Economic Impact Analysis:

The Fiscal Estimate and Economic Impact Analysis is attached.