Arkansas Administrative Code › Agency 038 - Board of Dental Examiners › Rule 038.00.08-001 - ARTICLE III: DISPENSING LEGEND DRUGS - F) Who dispenses legend drugs

Current through Register Vol. 49, No. 6, June, 2024
F. Who dispenses
		  legend drugs. Dentists who choose to dispense legend drugs directly to their
		  patients are subject to the following definitions and requirements:
1. A dispensing dentist is a dentist licensed
		  under Ark. Code Ann.
		  17-82-301
et seq.,
who purchases legend drugs to treat diseases,
		  disorders, and conditions of the oral cavity, maxillofacial area, and the
		  adjacent and associated structures and their impact on the human body, but not
		  for the purpose of treating diseases, disorders, and conditions unrelated to
		  the oral cavity, maxillofacial area, and the adjacent and associated
		  structures, to be dispensed to his or her patients for the patients' personal
		  use and administration outside the dentist's office.
2. The dispensing dentist shall:
a. Personally prepare and dispense legend
		  drugs and all the preparation and dispensing of such drugs may not be
		  delegated;
b. Keep records of all
		  receipts and distributions of legend drugs. The records shall be subject to
		  inspection by proper enforcement authority and shall be readily accessible and
		  maintained in a central registry;
c. Affix to the container a label showing:
i. The dentist's name, address and telephone
		  number
ii. The date of the
		  dispensing
iii. The serial number
		  of the prescription
iv. The name of
		  the patient
v. The trade name of
		  the medication, if any, or the generic name and identity of the manufacturer of
		  the dispensed medication
vi. The
		  strength per unit doses of the medication
vii. The quantity of the medication
viii. Directions for use
ix. Any cautionary statements required by
		  law
d. The dispensing
		  dentist shall counsel the patient in person ("face to face") to improve
		  therapeutic outcomes and prevent medication errors.
3. Except for dispensing samples without
		  charge, oral rinses or topicals, and emergency or starter dosages for use up to
		  seventy-two (72) hours, no dentist licensed under Ark. Code Ann.
		  17-82-301,
et seq.,
shall dispense legend drugs without prior approval by
		  the Arkansas State Board of Dental Examiners after application to the Board and
		  upon the showing of need. A dentist shall dispense only to his own patients and
		  only for conditions being treated by that dentist.
4. Any dentist desiring to dispense legend
		  drugs which are not exempted by Paragraph 3 of this regulation from the
		  requirement of prior approval of the Arkansas State Board of Dental Examiners
		  shall apply to the board on a form provided for that purpose and shall be
		  required to demonstrate the need for such dispensing of legend drugs prior to
		  receiving approval.
5. Violation of
		  this regulation shall constitute "professional misconduct" and shall subject
		  the violator to disciplinary action as provided in Ark. Code. Ann.
		  17-82-316
		  and Ark. Code Ann.
		  17-82-317,
6. The Arkansas State Board of Dental
		  Examiners shall enforce the provisions of this regulation.