CHAPTER 16
PRESCRIBING, ADMINISTERING, AND DISPENSING DRUGS
[Prior to 5/18/88, Dental Examiners, Board of[320]]
650—16.1(124,153,155A) Definitions.
“Controlled substance” means a drug or other substance listed in division II of Iowa Code chapter 124.
“Electronic signature” means a confidential personalized digital key, code, or number used for secure electronic data transmissions which identifies and authenticates the signatory.
“Electronic transmission” means the transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment. Electronic transmission includes but is not limited to transmission by facsimile machine and transmission by computer link, modem, or other computer communication device.
“Prescription drug” means any of the following: (a) a substance for which federal or state law requires a prescription before it may be legally dispensed to the public; (b) a drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements: (1) Caution: Federal law prohibits dispensing without a prescription or (2) Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian; or (c) a drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only, or is restricted to use by a practitioner only.
650—16.2(153) Scope of authority.
	16.2(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 related to the practice of dentistry within the scope of the dentist-patient relationship. Registration with the Federal Drug Enforcement Administration and the Iowa board of pharmacy examiners further extends this privilege to controlled substances.
	16.2(2) A dental examination must be conducted and a medical history taken before a dentist initially prescribes, administers, or dispenses medication to a patient, except for patients who receive fluoride or silver diamine fluoride dispensed under protocols approved by the bureau of oral and health delivery systems of the department of public health. The examination must focus on the patient’s dental problems, and the resulting diagnosis must relate to the patient’s specific complaint. The patient’s dental record must contain written evidence of the examination and medical history.
	16.2(3) On each occasion when a medication is prescribed, administered, or dispensed to a patient an entry must be made in the patient’s dental record containing the following information: the name, quantity, and strength of the medication; the directions for its use; the date of issuance; and the condition for which the medication was used.
	16.2(4) A patient’s dental record that contains an entry pertaining to the issuance of medications must be retained in accordance with 650—27.11(153,272C).
	16.2(5) The prescribing, administering, and dispensing of prescription drugs shall be done in accordance with all applicable state and federal laws.
[ARC 3987C, IAB 8/29/18, effective 10/3/18]
650—16.3(153) Purchasing, administering, and dispensing of controlled substances.
	16.3(1) When controlled substances are purchased, records must be maintained showing the date of receipt, the name and address of the supplier, the name and quantity of drugs received.
	16.3(2) When controlled substances are administered or dispensed, including samples, records that are readily retrievable and separate and apart from the patient records must be maintained showing date of dispensing, name and address of person to whom the drugs were administered or dispensed, and the name, quantity, and strength of drugs administered or dispensed.
	16.3(3) All controlled substance records must be retained for a period of two years from the date of the last entry. All records must be readily available for inspection by state or federal agents.
	16.3(4) Every two years the dentist is required to perform a complete inventory of all controlled substances in stock.
	16.3(5) Security of controlled substances must be maintained by storage in a securely locked, substantially constructed cabinet.
	16.3(6) The dentist shall notify the board of pharmacy examiners of the loss or theft of controlled substances within two weeks of the discovery of the loss or theft.
	16.3(7) A dentist shall not self-prescribe, self-administer, or self-dispense controlled substances or tramadol.
	16.3(8) Prescribing, administering, or dispensing controlled substances or tramadol to members of the licensee’s immediate family is not allowed except for an acute dental condition or on an emergency basis for a dental condition when the licensee conducts an examination, establishes a patient record, and maintains proper documentation.
[ARC 8369B, IAB 12/16/09, effective 1/20/10]
650—16.4(153) Dispensing—requirements for containers and labeling.
	16.4(1) Containers. A prescription drug shall be dispensed in a container which meets the requirements of the Poison Prevention Packaging Act of 1970, 15 U.S.C. §§ 1471-1476 which relates to childproof closure, unless otherwise required by the patient. Containers must also meet the requirements of Section 502G of the Federal Food Drug and Cosmetic Act, 21 U.S.C. §301 et seq.	which pertains to light resistance and moisture-resistance needs of the drug being dispensed.
	16.4(2) Labeling. A label shall be affixed to the container in which a prescription drug is dispensed bearing the following information:
	1.	Name and address of the dentist.
	2.	Name of the patient.
	3.	Date dispensed.
	4.	Directions for use.
	5.	Name, quantity, and strength of medication.
	6.	If it is 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.”
	7.	Cautionary statements, if any.
	16.4(3) Prescription sample drugs dispensed in the original container or package and provided without charge shall be deemed to conform to labeling and packaging requirements.
650—16.5(153) Identifying information on prescriptions.
	16.5(1) Prescriptions for Schedule II, III, IV, and V controlled substances must include the name and address of the prescribing dentist and the dentist’s federal DEA number. The name and address of the prescribing dentist may be preprinted. Proper security shall be maintained if prescription forms are preprinted.
	16.5(2) The dentist’s signature on a prescription must be original or an electronic signature, not a copy or stamp, except as the use of electronic signatures may be limited by federal or state law.
	16.5(3) On each occasion when medication is prescribed to a patient, the prescription issued to the patient shall contain the following information: the name of the patient for whom the prescription is intended; the name, quantity, and strength of the medication; the directions for its use; the date of issuance; and the name, address, and signature of the dentist issuing the prescription.
650—16.6(153) Transmission of prescriptions. A prescription drug order may be transmitted to a pharmacy in written form, orally including telephone voice communication, or by electronic transmission in accordance with applicable federal and state laws and rules. A dentist shall take adequate measures to guard against the diversion of prescription drugs and controlled substances through prescription forgeries. The dentist may authorize an employee to transmit to the pharmacy a prescription drug order orally or by electronic transmission provided that the identity of the transmitting employee is included in the order.
	16.6(1) Computer-to-computer transmission of a prescription. Prescription drug orders, excluding orders for controlled substances, may be communicated directly from a dentist’s computer to a pharmacy’s computer by electronic transmission.
	a. 	Orders shall be sent only to the pharmacy of the patient’s choice with no unauthorized intervening person or other entity controlling, screening, or otherwise manipulating the prescription drug order or having access to it.
	b. 	The electronically transmitted order shall identify the dentist’s telephone number for verbal confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission as well as any other information required by federal or state law or rules.
	c. 	Orders shall be transmitted only by the dentist or the dentist’s employee and shall include the dentist’s electronic signature.
	d. 	The electronic transmission shall be deemed the original prescription drug order provided it meets the requirements of this rule.
	16.6(2) Facsimile transmission of a prescription. A dentist may request that a pharmacist dispense noncontrolled and controlled drugs, excluding Schedule II controlled substances, pursuant to a prescription transmitted to the pharmacy by the dentist or the dentist’s employee. A dentist shall maintain the original prescription, if printed, in the patient’s record.
650—16.7(153) Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate prescription may be telephoned to a pharmacist. An emergency prescription for a Schedule II controlled substance must be covered by a written prescription within 72 hours. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history.
	16.7(1) For the purpose of authorizing an oral prescription of a controlled substance listed in Schedule II of the uniform controlled substances Act, Iowa Code chapter 124, the term “emergency situation” means those situations in which the prescribing dentist determines:
	a. 	That immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;
	b. 	That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of Iowa Code chapter 124;
	c. 	That it is not reasonably possible for the prescribing dentist to provide a written prescription to be presented to the person dispensing the substance prior to dispensing.
	16.7(2) Reserved.
These rules are intended to implement Iowa Code section 153.20.
[Filed 1/23/87, Notice 12/17/86—published 2/11/87, effective 3/18/87]
[Filed 4/28/88, Notice 3/23/88—published 5/18/88, effective 6/22/88]
[Filed emergency 10/23/00—published 11/15/00, effective 10/23/00]
[Filed 1/19/01, Notice 11/15/00—published 2/7/01, effective 3/14/01]
[Filed 7/1/04, Notice 5/12/04—published 7/21/04, effective 8/25/04]
[Filed ARC 8369B (Notice ARC 8044B, IAB 8/12/09), IAB 12/16/09, effective 1/20/10]
[Filed ARC 3987C (Notice ARC 3849C, IAB 6/20/18), IAB 8/29/18, effective 10/3/18]