(f) The risk to the public health.
(g) The potential of the substance to produce psychological or physical dependence liability.
(h) Whether the substance is an immediate precursor of a substance already controlled under this chapter.
The controlled substances board may consider findings of the federal food and drug administration or the drug enforcement administration as prima facie evidence relating to one or more of the determinative factors.
After considering the factors, the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse. [s. 961.11 (1m), (1r), and (2), Stats.] The controlled substances board may add a substance to schedule IV without making the finding required under sub. (1m) if the substance is controlled under schedule IV of 21 USC 812 (c) by a federal agency as the result of an international treaty, convention or protocol. [s. 961.19 (2m), Stats.] Related statute or rule: s. 961.20, Stats. Plain language analysis:
This rule schedules flualprazolam as a Schedule IV controlled substance.
Summary of, and comparison with, existing or proposed federal regulation:
Flualprazolam is not currently scheduled under the Controlled Substances Act.
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 has not scheduled flualprazolam as a controlled substance.
Iowa: Iowa has not scheduled flualprazolam as a controlled substance.
Michigan: Michigan has not scheduled flualprazolam as a controlled substance.
Minnesota: Minnesota has not scheduled flualprazolam as a controlled substance.
Summary of factual data and analytical methodologies:
Flualprazolam is an analog of alprazolam (an FDA approved schedule IV controlled substance), differing in chemical composition by the presence of a fluorine atom. Flualprazolam is a benzodiazepine synthesized and patented in 1970s for research purposes but was never marketed as a medicine. Flualprazolam is not used clinically.
The onset of action due to flualprazolam is reported to be 10-20 minutes after oral use with a duration of action of 6-14 hours. Flualprazolam depresses the central nervous system resulting in sedation, reduced anxiety, and loss of consciousness. Flualprazolam is similar to alprazolam which has demonstrably greater abuse liability compared to diazepam, especially for those with a personal or family substance use disorder history.
The World Health Organization released a critical review report on flualprazolam in October 2019. On March 4, 2020, the United Nations Commission on Narcotic Drugs placed flualprazolam under international control as a Schedule IV. Delaware added several benzodiazepines, including flualprazolam, to Schedule IV due to the serious potential for abuse. Flualprazolam is on several states’ law enforcement watchlists or alerts.
In 2019 and 2020, there has been an increased prevalence of flualprazolam in the United States. Law enforcement officers and medical examiners have provided information to the Controlled Substances Board indicating this substance is implicated in Wisconsin overdose cases, including those resulting in death. Alprazolam is not a schedule I controlled substance, therefore, a prosecution involving flualprazolam can’t be commenced under Wisconsin’s analog law (s. 961.25, Stats). Public health concerns are similar to other benzodiazepines which are higher potency with a relatively fast time of onset. When flualprazolam is combined with opioids, this contributes to increased overdose through benzodiazepine-potentiated opioid-induced respiratory depression. In addition, flualprazolam causes disinhibition and sedation that impair driving. There have been reports of intentionally counterfeit alprazolam product containing flualprazolam entering the drug supply chain in other states.
Flualprazolam has a fast onset of action and similarities to alprazolam and has a relatively high dependence liability.
The Controlled Substances Board considered the following factors in making the determination to add flualprazolam to the controlled substance schedules in ch. 961, Stats.:
The actual or relative potential for abuse.
The scientific evidence of its pharmacological effect.
The state of current scientific knowledge regarding the substance.
The history and current pattern of abuse.
The scope, duration and significance of abuse.
The risk to the public health.
The potential of the substance to produce psychological or physical dependence liability.
Whether the substance is an immediate precursor of a substance already controlled under ch. 961, Stats.The Controlled Substances Board makes a finding that flualprazolam has a potential for abuse.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
The rule draft was posted on the department’s 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 2.77 is created to read:
CSB 2.77 Scheduling of flualprazolam. Section 961.20 (2) (ef), Stats., is created to read: 961.20 (2) (ef) flualprazolam.
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 __________________________________
