239.02.22 Ark. Code R. 001

Current through Register Vol. 49, No. 10, October, 2024

Rule 239.02.22-001 - Rule 12 - Dispensing

SECTON I:APPROVAL TO DISPENSE: LEGEND DRUGS

1. Any physician desiring to dispense legend drugs shall apply to the Arkansas State Medical 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.

2. This section does not apply to;

a. Licensed physicians who were dispensing in the ordinary course of his/her practice before April 12, 2013 shall be exempt from the licensing requirements of this section.

b. Physicians who only dispense drugs in injectable form unless they are controlled substances, in which case this section shall apply fully.

c. Physicians dispensing topical medication. Naloxone, nicotine replacement therapy, contraceptives, acute care medication that is a legend but not a controlled substance prescribed for no more than fourteen (14) days, and initial treatment for maintenance medication.

i. Acute care medication includes the following oral medications:

1. To treat infections;

2. Anti-inflammatory medications;

3. Antinausea medications;

4. Antihistamines; and

5. Cough medications.

ii. Initial treatment for maintenance medication means a legend drug that:

1. Is not a controlled substance;

2. Is prescribed for no more than thirty (30) days;

3. And is used to treat hypertension, diabetes mellitus, or hypercholesterolemia.

3. A "dispensing physician" is a physician licensed under the Arkansas Medical Practices Act who purchases legend drugs to be dispensed to his/her patients for the patients' personal use and administration outside the physician's office. A dispensing physician shall:

a. Personally dispense legend drugs, and the dispensing of legend drugs may be delegated;

b. Keep records of all receipts and distributions of legend drugs;

c. Label drugs with the following information:

i. Patient's name and address;

ii. Prescribing physician's address, narcotic registry number issued by the U.S. DEA, or national provider identification number;

iii. Date of dispensing; and

iv. Directions and cautionary statements, if any, required by law; and

d. Make all records readily accessible for inspection by a designated inspector of the Arkansas State Medical Board and at its direction during all regular business hours.

SECTION II:DISPENSING REQUIREMENTS

1. All records maintained by a dispensing physician shall be subject to inspection by a designated inspector of the Arkansas State Medical Board and at its direction during all regular business hours.

2. Any dispensing physician or delegated individual participating in the preparation of orders or dispensing of prescriptions or any dispensing physician who is responsible for supervising personnel participating in the preparation of orders or dispensing of prescriptions is responsible for the validity and legality of the order or prescription.

(a) Any dispensing physician who is responsible for supervising personnel is also responsible for any shortage of drugs classified as controlled drugs under state or federal law which occurs under their his/her supervision.

(b) The dispensing physician is responsible for the security and accountability of all drugs stored and is responsible for the validity and legality of all prescriptions or orders upon which drugs are dispensed. The dispensing physician is responsible for ensuring that delegated staff has been appropriately trained to follow all policies and procedures.

3. An inventory is to be maintained, monitored, and recorded jointly by the dispensing physician and delegated employees.

History: Adopted June 16. 1983, Amended Act 503 of 2021

239.02.22 Ark. Code R. 001

Adopted by Arkansas Register Volume 47 Number 10, Effective 10/13/2022