CR 18-055 Rule Text

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

On March 23, 2017, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing Food and Drug Administration approved products of oral solutions containing dronabinol into Schedule II 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 products of oral solutions containing dronabinol as a schedule II controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on May 12, 2017 to similarly treat Food and Drug Administration approved products of oral solutions containing dronabinol under chapter 961 effective May 15, 2017 to allow for publication in the Administrative Register. The Affirmative Action Order will expire upon promulgation of a final rule.

This rule creates s. 961.16 (10) (a), Stats. which adds Food and Drug Administration approved products of oral solutions containing dronabinol to schedule II.

Comparison with rules in adjacent states:

Illinois: Illinois has not scheduled Food and Drug Administration approved products of oral solutions containing dronabinol.

Iowa: Iowa has not scheduled Food and Drug Administration approved products of oral solutions containing dronabinol.

Michigan: Michigan has not scheduled Food and Drug Administration approved products of oral solutions containing dronabinol.

Minnesota: Minnesota has not scheduled Food and Drug Administration approved products of oral solutions containing dronabinol.

Summary of factual data and analytical methodologies:

The methodology was to schedule Food and Drug Administration approved products of oral solutions containing dronabinol 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, 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, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received by August 22, 2018 to be included in the record of rule-making proceedings.

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TEXT OF RULE

Section 1. CSB 2.54 is created to read:

CSB 2.54 Addition of Oral Solutions containing dronabinol to schedule II. Section 961.16 (10) (a), Stats., is created to read:

961.16 (10) (a) Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in an oral solution in a drug product approved by the U.S. food and drug administration.

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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