ARC 5195C

ARC 5195C

PHARMACY BOARD[657]

Notice of Intended Action

Proposing rule making related to temporary designation of controlled substances and providing an opportunity for public comment

The Board of Pharmacy hereby proposes to amend Chapter 10, "Controlled Substances," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in Iowa Code sections 124.201 and 124.201A and 2020 Iowa Acts, Senate File 2119.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code sections 124.201 and 124.201A and 2020 Iowa Acts, Senate File 2119.

Purpose and Summary

The proposed amendments to rule 657—10.39(124) make temporary amendments to the Iowa Code for scheduling action in the Iowa Controlled Substances Act to match similar action taken by the federal Drug Enforcement Administration. The proposed amendments add one substance (synthetic opioid) to Schedule I and remove FDA-approved cannabidiol products containing less than 0.1 percent tetrahydrocannabinol (THC).

The proposed amendments add two subrules to current rule 657—10.39(124). The new subrules may be renumbered upon adoption as 10.39(4) and 10.39(5) to conform to the hierarchy of the new rule 657—10.39(124) proposed in ARC 5155C, IAB 8/26/20.

Fiscal Impact

This rule making has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rule making, no impact on jobs has been found.

Waivers

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.

Public Comment

Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on October 13, 2020. Comments should be directed to:

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)"b," an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

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).

The following rule-making actions are proposed:

Item 1. Adopt the following new subrule 10.39(8):

10.39(8) Amend Iowa Code section 124.212 as amended by 2020 Iowa Acts, Senate File 2119, by rescinding subsection 6.

Item 2. Adopt the following new subrule 10.39(9):

10.39(9) Amend Iowa Code section 124.204(9) as amended by 2020 Iowa Acts, Senate File 2119, by adding the following new paragraph:

ay. N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (other names: isotonitazene; N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine).