Explanation of agency authority:
The secretary of the department of safety and professional services shall, after consultation with the optometry examining board, the medical examining board and the pharmacy examining board, promulgate rules specifying those therapeutic pharmaceutical agents that may or may not be prescribed or administered. [s 449.18 (6) (cm), Stats.]
Related statute or rule: n/a
Plain language analysis:
Hydrocodone combination products were rescheduled to Schedule II controlled substances by the federal government effective October 6, 2014 and the Wisconsin Controlled Substances Board effective November 1, 2014. The scheduling change removed the ability for optometrists to prescribe hydrocodone combination products. 2015 Act 34 specifically added language to the statutes to allow optometrists to prescribe hydrocodone combination products pursuant to promulgation of rules. Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois allows the prescribing of hydrocodone combination products by optometrist.
Iowa: Iowa allows the prescribing of hydrocodone combination products by optometrist.
Michigan: Michigan allows the prescribing of hydrocodone combination products by optometrists.
Minnesota: Minnesota allows the prescribing of hydrocodone combination products by optometrists.
Summary of factual data and analytical methodologies:
The Department consulted with the Medical Examining Board, Optometry Examining Board and Pharmacy Examining Board. The Department is promulgating rules in accordance with 2015 Act 34 provisions. Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted for economic comments and none were received. This rule restores the ability to optometrists to prescribe hydrocodone combination products.
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 Jeff.Weigand@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at Sharon.Henes@wisconsin.gov. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. SPS 10.01 (10) (intro) is amended to read:
“Therapeutic pharmaceutical agent” means a drug which is prescribed or administered for ocular therapeutic purposes. Therapeutic Except as provided in par. (am), therapeutic pharmaceutical agents include but are not limited to all of the following:
Section 2. SPS 10.01 (10) (am) is created to read:
SPS 10.01 (10) (am) Controlled substances in schedule II, limited to either of the following:
1. Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with a four-fold or greater quantity of an isoquinoline alkaloid of opium.
2. Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
Section 3. 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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