Related statute or rule: s. 961.14, Stats. Summary of, and comparison with, existing or proposed federal regulation:
On May 12, 2016, the Department of Justice, Drug Enforcement Administration published its final rule in the Federal Register placing brivaracetam into Schedule V of the federal Controlled Substances Act.
Plain language analysis:
The Controlled Substances Board did not receive an objection to treating brivaracetam as a schedule V controlled substance under ch. 961, Stats. based upon the federal scheduling. The Controlled Substances Board took affirmative action on September 6, 2016 to similarly treat brivaracetam under chapter 961 effective September 26, 2016 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 (6), Stats. which adds brivaracetam to schedule V. Comparison with rules in adjacent states:
Illinois: Illinois has not scheduled brivaracetam.
Iowa: Iowa is in the process of scheduling brivaracetam as a schedule V controlled substance.
Michigan: Michigan has not scheduled brivaracetam.
Minnesota: Minnesota has not scheduled brivaracetam.
Summary of factual data and analytical methodologies:
The methodology was to schedule brivaracetam 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 Greg.Gasper@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov. 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, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received by March 10, 2017 to be included in the record of rule-making proceedings. TEXT OF RULE
Section 1. CSB 2.43 is created to read:
CSB 2.43 Addition of brivaracetam to schedule V. Section 961.22 (6), Stats., is created to read: 961.22(6) Brivaracetam. Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide), including its salts, isomers or salts of isomers.
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)
