ARC 9343C - Iowa Administrative Rules

Adopted and Filed

Board of pharmacy operations, ch 557

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ARC 9343C

INSPECTIONS AND APPEALS DEPARTMENT[481]

Adopted and Filed

Rulemaking related to board of pharmacy operations

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

Legal Authority for Rulemaking

This rulemaking is adopted 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

This rulemaking provides 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.

Public Comment and Changes to Rulemaking

Notice of Intended Action for this rulemaking was published in the Iowa Administrative Bulletin on November 27, 2024, as ARC 8424C. A public hearing was held on the following date(s):

●January 6, 2025

●January 9, 2025

The Iowa Pharmacy Association expressed its support of the Board’s rulemaking. No public comments were received.

Changes from the Notice have been made in subrule 557.1(6) to identify two additional general licensing chapters for the DIAL’s Licensing Division to be adopted by reference.

Adoption of Rulemaking

This rulemaking was adopted by DIAL on May 8, 2025.

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.

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).

Effective Date

This rulemaking will become effective on July 16, 2025.

The following rulemaking action is adopted:

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.

h.Model rules for board administrative processes as found in 481—Chapter 500.

i.Model rules for complaints and investigations as found in 481—Chapter 503.

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