CR 20-077 Rule Text

Plain language analysis:

The Controlled Substances Board took affirmative action on June 23, 2020 to similarly treat U.S. Food and Drug Administration approved cannabidiol under chapter 961 effective June 29, 2020 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.

This rule repeals s. 961.22 (7), Stats., removing Food and Drug Administration approved cannabidiol from Schedule V.

In addition, this rule creates s. 961.14 (4) (t) 4., Stats., creating an exception from Schedule I (under tetrahydrocannabinols) for an FDA approved cannabidiol derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols. This exception is created so that the repeal of FDA approved cannabidiol from Schedule V does not revert these substances to inclusion in Schedule I.

Comparison with rules in adjacent states:

Illinois: Illinois does not schedule Food and Drug Administration approved cannabidiol.

Iowa: Iowa schedules Food and Drug Administration approved cannabidiol as Schedule V controlled substances.

Michigan: Michigan does not schedule Food and Drug Administration approved cannabidiol.

Minnesota: Minnesota does not schedule Food and Drug Administration approved cannabidiol.

Summary of factual data and analytical methodologies:

The methodology was to remove cannabidiol from scheduling.

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:

Jon Derenne, 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 Jon Derenne, 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 January 14, 2020 to be included in the record of rule-making proceedings.

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TEXT OF RULE

Section 1. CSB 2.75 is created to read:

CSB 2.75 Exclusion of Approved Cannabidiol Drugs from schedule I and deleting from schedule V. (1) Section 961.14 (4) (t) 4., Stats., is created to read:

961.14 (4) (t) 4. 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.

(2) Section 961.22 (7), Stats., is repealed.

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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