Notice of Intended Action

Board of pharmacy operations, ch 557

Untitled document

ARC 8424C

INSPECTIONS AND APPEALS DEPARTMENT[481]

Notice of Intended Action

Proposing rulemaking related to board of pharmacy operations
and providing an opportunity for public comment

The Department of Inspections, Appeals, and Licensing (DIAL) hereby proposes to adopt new Chapter 557, “Board of Pharmacy Operations,” Iowa Administrative Code.

Legal Authority for Rulemaking

This rulemaking is proposed under the authority provided in Iowa Code chapters 21, 124, 124B, 155A and 272C and sections 17A.3 and 147.80.

State or Federal Law Implemented

This rulemaking implements, in whole or in part, Iowa Code chapters 17A, 21, 124, 124B, 155A and 272C and section 147.80.

Purpose and Summary

The purpose of this proposed rulemaking is to provide information about Board of Pharmacy operationsand responsibilities, including information about Board meetings, administrative fees and references to other applicable DIAL rules that will be adopted by reference. No comments were received following publication of the regulatory analysis.

Regulatory Analysis

A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on August 7, 2024. A public hearing was held on the following date(s):

●August 29, 2024

Fiscal Impact

This rulemaking has no fiscal impact to the State of Iowa.

Jobs Impact

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

Waivers

Any person who believes that the application of the discretionary provisions of this rulemaking would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 481—Chapter 6.

Public Comment

Any interested person may submit written comments concerning this proposed rulemaking, which must be received by the Board no later than 4:30 p.m. on January 9, 2025. Comments should be directed to:

Sue Mears
Iowa Department of Inspections, Appeals, and Licensing
6200 Park Avenue, Suite 100
Des Moines, Iowa 50321
Email: sue.mears@dia.iowa.gov

Public Hearing

Public hearings at which persons may present their views orally or in writing will be held as follows:

January 6, 2025
10:30 a.m.

Suite 100
6200 Park Avenue
Des Moines, Iowa

January 9, 2025
9:30 a.m.

Suite 100
6200 Park Avenue
Des Moines, Iowa

Persons who wish to make oral comments at a public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rulemaking.

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rulemaking 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 rulemaking action is proposed:

ITEM 1.Adopt the following new481—Chapter 557:

CHAPTER 557

BOARD OF PHARMACY OPERATIONS

481—557.1(17A,147,155A,272C) Board of pharmacy operations.

557.1(1) Authority. The board’s authority for regulating the practice of pharmacy and the legal distribution and dispensing of prescription drugs and devices, including controlled substances, in the state of Iowa is found in Iowa Code chapters 124, 124B, 126, 147, 155A, 205 and 272C.

557.1(2) Responsibilities. The responsibilities of the board include but are not limited to:

a.Licensing of individuals. Licensing or registering qualified individuals in the practice of pharmacy and the handling or prescribing of controlled substances.

b.Licensing of practice locations. Licensing or registering authorized entities engaged in the legal distribution or dispensing of prescription drugs, devices and controlled substances within or into Iowa.

c.Conducting compliance inspections, audits and investigations of any persons or entities licensed or registered with the board.

d.Instituting disciplinary actions, hearing contested cases, issuing decisions and orders, and enforcing the terms of filed disciplinary orders.

557.1(3) Meetings. All meetings of the board will be open to the public except as authorized by the Iowa Code. Meeting notices will be routinely posted on the department of inspections, appeals, and licensing’s website.

557.1(4) Administrative fees. The following nonrefundable fees will be assessed for the following administrative services:

a.Written license or registration verification: $15.

b.Provision of licensee data files: variable, $35 minimum.

c.Returned payment: $20.

d.Original pharmacist license certificate: $20.

e.Certification of pharmacist-intern internship hours: $15.

f.Petition for eligibility determination: $25.

557.1(5) Overpayment of fees. Payment for any administrative service or license fee in excess of the required fee amount of $10 or less will not be refunded.

557.1(6) Adoption of agency rules by reference. The board adopts by reference the following rules of the department:

a.Public records and fair information practices as found in 481—Chapter 5.

b.Petitions for rulemaking as found in 481—Chapter 2.

c.Declaratory orders as found in 481—Chapter 3.

d.Agency procedure for rulemaking as found in 481—Chapter 4.

e.Sales of goods and services as found in rule 481—1.12(10A,68B).

f.Licensee review committee as found in 481—Chapter 505.

g.Waivers as found in 481—Chapter 6.

This rule is intended to implement Iowa Code chapters 17A, 21, 124, 124B, 155A and 272C and section 147.80.

Closed For Comments

This notice is now closed for comments. Collection of comments closed on 8/7/2024.

Official Document

The official published PDF of this document is available from the Iowa General Assembly’s Administrative Rules page.

View Official PDF

View the Iowa Administrative Bulletin for 11/27/2024.

View Bulletin

Administrative Rule References

The following administrative rule references were added to this document. You may click a reference to view related notices.

Rule 481-1.12 Rule 481-557.1

Iowa Code References

The following Iowa code references were added to this document. You may click a reference to view related notices.

Iowa Code 124 Iowa Code 124B Iowa Code 126 Iowa Code 147 Iowa Code 147.80 Iowa Code 155A Iowa Code 17A Iowa Code 205 Iowa Code 21 Iowa Code 272C

Keywords

The following keywords and tags were added to this document. You may click a keyword to view related notices.

Administrative fees Adoption of agency rules by reference Authority Board of pharmacy operations Meetings Overpayment of fees Responsibilities
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