CR 19-012 Rule Text

On September 28, 2018, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing Food and Drug Administration approved drug products that contain cannabidiol into Schedule V of the federal Controlled Substances Act.

Plain language analysis:

The Controlled Substances Board did not receive an objection to treating Food and Drug Administration approved drug products that contain cannabidiol as a schedule V controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on October 9, 2018 to similarly treat Food and Drug Administration approved drug products that contain cannabidiol under chapter 961 effective October 15, 2018 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.

This rule creates s. 961.22 (7), Stats. which adds Food and Drug Administration approved drug products that contain cannabidiol to schedule V.

Comparison with rules in adjacent states:

Illinois: Illinois has not scheduled Food and Drug Administration approved drug products that contain cannabidiol.

Iowa: Iowa scheduled Food and Drug Administration approved drug products that contain cannabidiol as schedule V controlled substances.

Michigan: Michigan has not scheduled Food and Drug Administration approved drug products that contain cannabidiol.

Minnesota: Minnesota scheduled Food and Drug Administration approved drug products that contain cannabidiol as schedule V controlled substances.

Summary of factual data and analytical methodologies:

The methodology was to schedule scheduled Food and Drug Administration approved drug products that contain cannabidiol as schedule V controlled substances 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 [e-mail], or by calling [phone].

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 [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Sharon Henes, 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 [e-mail]. Comments must be received by March 14, 2019 to be included in the record of rule-making proceedings.

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TEXT OF RULE

Section 1. CSB 2.65 is created to read:

CSB 2.65 Addition of approved cannabidiol drugs to schedule V. Section 961.22 (7), Stats., is created to read:

961.22 (7) Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the United States food and drug administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

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.

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(END OF TEXT OF RULE)

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