ARC 8503C

ARC 8503C

Proposing rulemaking related to prescribing, administering, and dispensing drugs
and providing an opportunity for public comment

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).

A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on October 2, 2024. Public hearings were held on the following date(s):

●October 22, 2024

There were no public comments received with regard to this chapter and no changes were made as a result.

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.

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 must appear on the label 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.