Temporary designation of controlled substances, 10.39(5)
Adopted and Filed
Rule making related to controlled substances
The Board of Pharmacy hereby amends Chapter 10, "Controlled Substances," Iowa Administrative Code.
Legal Authority for Rule Making
This rule making is adopted under the authority provided in Iowa Code section 124.201.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code section 124.201.
Purpose and Summary
This amendment temporarily places one substance (a new U.S. Food and Drug Administration (FDA)-approved medication to treat seizures) into Schedule V of the Iowa Controlled Substances Act in response to similar action taken by the federal Drug Enforcement Administration.
Public Comment and Changes to Rule Making
Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on July 27, 2022, as ARC 6425C. No public comments were received. No changes from the Notice have been made.
Adoption of Rule Making
This rule making was adopted by the Board on October 25, 2022.
This rule making has no fiscal impact to the State of Iowa.
After analysis and review of this rule making, no impact on jobs has been found.
Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).
This rule making will become effective on January 4, 2023.
The following rule-making action is adopted:
Rescind subrule 10.39(5) and adopt the following new subrule in lieu thereof:
10.39(5) Amend Iowa Code section 124.212(5) by adding the following new paragraph:
g. Ganaxolone (3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one).
[Filed 11/3/22, effective 1/4/23]
Editor's Note: For replacement pages for IAC, see IAC Supplement 11/30/22.
The official published PDF of this document is available from the Iowa General Assembly’s Administrative Rules page.
View the Iowa Administrative Bulletin for 11/30/2022.
The following administrative rule references were added to this document. You may click a reference to view related notices.Rule 657-10.39(5)
The following Iowa code references were added to this document. You may click a reference to view related notices.Iowa Code section 124.212(5)