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. Summary of, and comparison with, existing or proposed federal regulation:
On June 5, 2020, the Department of Justice, Drug Enforcement Administration provided a letter to the Controlled Substances Board indicating that as a result of the Agricultural Improvement Act of 2018, the Federal Drug Administration approved drug product Epidiolex is no longer controlled under the federal Controlled Substances Act.
The Agricultural Improvement Act of 2018 defines the term “hemp” to “mean the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol (also known as 9-THC) concentration of not more than 0.3 percent on a dry weight basis.” (7 U.S.C. § 1639o.). The Agricultural Improvement Act of 2018 also amended the Controlled Substances Act by excluding “hemp” from the definition of marihuana under 21 U.S.C. § 802 (16) and the listing of tetrahydrocannabinols under 21 U.S.C. § 812 (c).
The prescription drug product Epidiolex is a cannabis derivative with a 9-THC concentration of not more than 0.3% on a dry weight basis. Therefore, as a result of the Department of Justice, Drug Enforcement Administration letter and the Agricultural Improvement Act, the drug product Epidiolex is no longer controlled under the federal Controlled Substances Act.
On August 21, 2020, the Department of Justice, Drug Enforcement Administration published its interim final rule in the Federal Register removing drug products approved by the U.S. Food and Drug Administration that contain cannabidiol derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols from schedule V.
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 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 in schedule V and to exempt it from reverting into schedule I in light of the DEA’s recent treatment of this drug.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
This rule schedules a drug and does not have an effect on small business. The rule draft was published on the department website for 14 days to solicit economic impact comments from small businesses. 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 Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Kevyn Radcliffe, 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 608-266-0797; email at DSPSAdminRules@wisconsin.gov. ------------------------------------------------------------------------------------------------------------
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. ------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated ___7/9/2021_______ Agency __________________________________
Chairperson
Controlled Substances Board
