Adopted and Filed

Prescribing, administering, and dispensing drugs, ch 578

Untitled document

ARC 8992C

INSPECTIONS AND APPEALS DEPARTMENT[481]

Adopted and Filed

Rulemaking related to prescribing, administering, and dispensing drugs

The Department of Inspections, Appeals, and Licensing hereby adopts new Chapter 578, “Prescribing, Administering, and Dispensing Drugs,” Iowa Administrative Code.

Legal Authority for Rulemaking

This rulemaking is adopted under the authority provided in Iowa Code chapters 124, 153A and 155A and section 153.33.

State or Federal Law Implemented

This rulemaking implements, in whole or in part, Iowa Code section 153.20.

Purpose and Summary

This rulemaking promulgates Chapter 578 and implements Iowa Code chapter 153 in accordance with the goals and directives of Executive Order 10. Iowa Code section 153.33 provides rulemaking authority.

This rulemaking implements Iowa Code section 153.20 by providing Iowans, licensees, and their employers with information relevant to the authority and requirements of licensed dentists who are prescribing, administering, or dispensing prescription drugs. This chapter also provides requirements for recordkeeping, labels and containers, and use of the Prescription Monitoring Program (PMP).

Public Comment and Changes to Rulemaking

Notice of Intended Action for this rulemaking was published in the Iowa Administrative Bulletin on December 11, 2024, as ARC 8503C. A public hearing was held on the following date(s):

●January 2, 2025

●January 3, 2025

Association representatives and a licensee were present for a public hearing. No public comments were received other than those in support of the rulemaking. No changes from the Notice have been made.

Adoption of Rulemaking

This rulemaking was adopted by the Dental Board on January 24, 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 April 9, 2025.

The following rulemaking action is adopted:

ITEM 1.Adopt the following new481—Chapter 578:

CHAPTER 578

PRESCRIBING, ADMINISTERING, AND DISPENSING DRUGS

481—578.1(153) Scope of authority and prescribing requirements.

578.1(1) A license to practice dentistry issued by this board permits the licensee to prescribe, administer, or dispense prescription drugs if the use is directly within the scope of the dentist-patient relationship. Registration with the federal Drug Enforcement Administration and the board of pharmacy extends this privilege to controlled substances.

578.1(2) A licensed dentist may only prescribe, administer or dispense a prescription drug for a diagnosed dental condition that is included in the treatment plan and entered into the patient record. A dental examination and medical history must be completed and entered into the patient record before a dentist prescribes, administers, or dispenses a prescription drug to a patient. Fluoride may also be dispensed under protocols approved by the dental and oral health program of the department of health and human services.

578.1(3) On each occasion when a dentist prescribes, administers, or dispenses a prescription drug to a patient, the patient’s dental record will be updated to include the following information:

a.Name, quantity, and strength of the prescription drug.

b.Directions for its use.

c.Date of issuance.

d.Conditions for which the prescription drug was used.

578.1(4) A dentist may only prescribe, administer, or dispense prescription drugs in accordance with all applicable state and federal laws.

578.1(5) A dentist may only purchase, administer, or dispense controlled substances if the dentist maintains records and accountability in accordance with 481—Chapter 553 and all other applicable state and federal laws.

578.1(6) A dentist cannot self-prescribe or self-administer controlled substances.

578.1(7) A dentist may only prescribe, administer, or dispense controlled substances to members of the licensee’s immediate family in the case of an acute dental condition or on an emergency basis for a dental condition after the licensee conducts an examination, establishes a patient record, and maintains proper documentation.

481—578.2(153) Dispensing—requirements for containers and labeling.

578.2(1) Containers. A prescription drug shall be dispensed in a suitable container designed to protect its integrity in accordance with all applicable federal and state laws.

578.2(2) Labeling. A label shall be affixed to the container in which a prescription drug is dispensed bearing the following information:

a.Name and address of the dentist.

b.Name of the patient.

c.Date dispensed.

d.Directions for use.

e.Name, quantity, and strength of medication.

f.If the prescription drug is a Schedule II, III, or IV controlled substance, the federal transfer warning statement as follows: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

g.Cautionary statements, if any.

481—578.3(153) Prescription requirements.

578.3(1) A dentist shall take adequate measures to prevent prescription forgery from occurring. Dentists may only transmit prescription drug orders, including prescriptions for controlled substances, electronically unless exempted. A dentist who fails to comply with the electronic prescription mandate may be subject to a nondisciplinary administrative penalty of $250 per violation, up to a maximum of $5,000 per calendar year.

578.3(2) A dentist may delegate to a licensed dental hygienist or registered dental assistant the preparation of a prescription for the review, authorization, and manual or electronic signature of the dentist, but the dentist is responsible for the accuracy, completeness, and validity of the prescription.

578.3(3) A dentist shall securely maintain the unique authentication credentials issued to the dentist for utilization of the electronic prescription application and authentication of the dentist’s electronic signature. Unique authentication credentials issued to any individual may not be shared with or disclosed to any other individual.

481—578.4(153) Required use of the prescription monitoring program (PMP).

578.4(1) A dentist may only prescribe or dispense an opioid if the dentist or authorized delegate queries the PMP. The query for each patient may not be performed more than 48 hours prior to each instance of an opioid prescription being authorized, issued, or dispensed.

578.4(2) A dentist who dispenses a controlled substance is required to report the dispensing to the PMP within one business day in accordance with 481—Chapter 556.

These rules are intended to implement Iowa Code section 153.20.

[Filed 2/13/25, effective 4/9/25]

[Published 3/5/25]

EDITOR’S NOTE: For replacement pages for IAC, see IAC Supplement 3/5/25.

Official Document

  • Prescribing, administering, and dispensing drugs, ch 578
  • Published on 3/5/2025
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  • Adopted and Filed

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

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View the Iowa Administrative Bulletin for 3/5/2025.

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Related Notices

Administrative Rule References

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

Rule 481-578.1 Rule 481-578.2 Rule 481-578.3 Rule 481-578.4

Iowa Code References

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

Iowa Code 153.20
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