038.00.08 Ark. Code R. 001

Current through Register Vol. 49, No. 9, September, 2024

Rule 038.00.08-001 - ARTICLE III: DISPENSING LEGEND DRUGS - F) Who dispenses legend drugs

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. 17-82-301et 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.

038.00.08 Ark. Code R. 001

7/14/2008