ARC 7025C

ARC 7025C

PHARMACY BOARD[657]

Adopted and Filed

Rule making related to Controlled Substances Act registration

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 124.301.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code section 124.302.

Purpose and Summary

This rule making authorizes the Board, on a case-by-case basis, to issue a Controlled Substances Act registration to a business location when it would be impractical to require each individual practitioner who administers or dispenses controlled substances to separately register at the business location. Examples of such business locations include, but are not limited to, ambulatory surgical centers, dialysis centers, federally qualified health centers, and standalone clinics associated with a hospital system.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on February 22, 2023, as ARC 6906C. The Board received one comment in support of the rule making. No changes from the Notice have been made.

Adoption of Rule Making

This rule making was adopted by the Board on May 2, 2023.

Fiscal Impact

This rule making has minimal fiscal impact to the State of Iowa. The number of business locations that would obtain a registration, at $90 for a two-year registration, is unknown but expected to be fewer than ten per year.

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.

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).

Effective Date

This rule making will become effective on July 5, 2023.

The following rule-making action is adopted:

Adopt the following new rule 657—10.4(124):

657—10.4(124) Who may register. On a case-by-case basis, the board may issue a registration to a business location not listed in rule 657—10.3(124) if it would be impractical to require each individual practitioner who administers or dispenses controlled substances to separately register at the business location. Examples of business locations that may be eligible for a registration pursuant to this rule include, but are not limited to, ambulatory surgical centers as defined in Iowa Code section 147.163, dialysis centers, federally qualified health centers, and standalone clinics associated with a hospital system.

[Filed 5/4/23, effective 7/5/23]

[Published 5/31/23]

Editor's Note: For replacement pages for IAC, see IAC Supplement 5/31/23.