ARC 6906C

ARC 6906C

PHARMACY BOARD[657]

Notice of Intended Action

Proposing rule making related to Controlled Substances Act registration

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 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 proposed rule making would authorize 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 is not limited to, ambulatory surgical centers, dialysis centers, federally qualified health centers, and standalone clinics associated with a hospital system.

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.

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 March 14, 2023. 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 action is proposed:

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.