Arizona Board of Medical Examiners

ARTICLE 2. DISPENSING OF DRUGS

R4-16-201. Registration and renewal

  1. A physician who wishes to dispense controlled substances and prescription-only drugs and devices shall be currently licensed to practice medicine in the State of Arizona and shall provide to the Board, the following:

    1. A completed form for registration, furnished by the Board, which includes the following information:

      1. The physician's name, license number and field of practice;

      2. A listing of the types of drugs and devices the physician desires to dispense, including prescription-only and controlled substances; and

      3. The location or locations where the physician desires to dispense.

    2. A copy of the physician's current Drug Enforcement Administration Certificate of Registration for each dispensing location from which the physician desires to dispense controlled substances.

    3. The statutorily required fee.

  2. A physician shall renew a registration to dispense drugs and devices by complying with the requirements set forth in subsection (A) on or before June 30 of each year. When a physician has made timely and complete application for the renewal of a registration, the physician may continue to dispense until the application has been approved or denied by the board.

  3. If the completed annual renewal form, all required documentation and the correct fee are not received in the Board's office on or before June 30, the physician shall not dispense drugs and devices until newly registered. The physician shall register by filing for initial registration pursuant to subsection (A) and shall not dispense drugs and devices until receipt of a new registration.


R4-16-202. Packaging and inventory; exception

  1. A physician shall dispense all drugs in prepackaged containers or in light resistant containers with a consumer safety cap, unless a patient or a patient's representative requests a non-safety cap.

  2. All drugs dispensed shall be labeled with the following information:

    1. The physician's name, address and telephone number;

    2. The date the drug is dispensed and its expiration date;

    3. The patient's name; and

    4. The name, form, name of the manufacturer and strength of the drug, the quantity dispensed, directions for its use, and any cautionary statement necessary for the safe and effective use of the drug.

  3. A physician shall secure all controlled substances in a locked cabinet or room, and shall control access to the cabinet or room by a written procedure which shall include, at a minimum, designation of the persons who have access to the cabinet or room and procedures for recording requests for access to drugs. This written procedure shall be made available on demand to the Board or its authorized representatives for inspection or copying. Prescription-only medications shall be stored so as not to be accessible to patients.

  4. Drugs not requiring refrigeration shall be maintained in an area where the temperature does not exceed eighty-five degrees Fahrenheit.

  5. A physician shall maintain an ongoing dispensing log for all controlled substances and the prescription-only medications nalbuphine hydrochloride (Nubain) and butorphanol tartrate (Stadol) dispensed by the physician which includes separate inventory sheets for each controlled substance, nalbuphine hydrochloride and butorphanol tartrate. The heading of a dispensing log shall include the following information:

    1. The date the drug is dispensed;

    2. The patient's name;

    3. The name, form, name of the manufacturer and strength of the drug;

    4. The number of dosage units dispensed;

    5. A running total of medication dispensed; and

    6. The signature of the physician or the person authorized by the physician who dispensed the medication, written next to each entry.

  6. The dispensing log required in subsection (E) may be maintained on computer provided that the log is quickly accessible through either on-screen viewing or printing of a copy.

  7. This section shall not apply to prepackaged, manufacturer samples of drugs, unless otherwise provided by federal law.


R4-16-203. Prescribing and dispensing requirements

  1. A physician shall record on the patient's medical record the name, form and strength of the drug or device dispensed, the quantity or volume dispensed, the date the drug or device is dispensed, the medical reasons for dispensing the drug or device, and the number of refills authorized.

  2. Prior to delivery to the patient, a physician shall review the prepared drugs and devices to ensure their compliance with the prescription and, additionally, ensure that the patient has been informed of the name of the drug or device, directions for its use, precautions and storage requirements.

  3. A physician shall purchase all dispensed drugs and devices from a manufacturer or distributor approved by the United States Food and Drug Administration, or a pharmacy holding a current, valid permit from the Arizona Board of Pharmacy.

  4. The person who prepares drugs and devices for dispensing shall countersign and date the original prescription form for the drugs and devices.

  5. For purposes of this article, "dispensing" means the delivery of a drug or device to a patient for use outside the physician's office.


R4-16-204. Recordkeeping and reporting shortages

  1. All original prescription orders dispensed from a physician's office shall be date, consecutively numbered in the order in which they were originally dispensed, and filed separately from the patient medical records. Original prescription orders for Schedule II drugs or other controlled substances, shall be maintained separately from other prescription orders.

  2. A physician shall maintain drug purchase orders and invoices for controlled substances, nalbuphine hydrochloride and butorphanol tartrate which are received, and original prescription orders for all drugs for a period of three years from the date of the order. Dispensing logs and destruction records shall also be maintained for three years.

  3. A physician who determines that drugs have been illegally removed from the physician's office, or that a drug shortage exists in controlled substances maintained for dispensing, shall immediately notify a local law enforcement agency and, thereafter, provide that agency with a report in writing, with copies to the Drug Enforcement Administration and the Board within seven days of the discovery.

  4. For purposes of this section, "Schedule II drugs or other substances" means the controlled substances identified, defined or listed in A.R.S. 36-2513 and the following hallucinogenic substances:

    1. Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product.

    2. Nabilone.


R4-16-205. Inspections; denial and revocation

  1. A physician shall cooperate with and allow access by the Board or its authorized representatives to the physician's office and records during periodic inspections of dispensing practices by the Board. Failure to cooperate or allow access shall be grounds for revocation of a physician's registration to dispense or denial of renewal of registration.

  2. Failure to comply with A.R.S. 32-1491 or this article shall constitute grounds for denial or revocation of registration.

  3. A physician's registration to dispense drugs and devices shall be revoked by the Board upon occurrence of the following:

    1. Suspension, revocation or cancellation of the physician's license,

    2. Placement of the physician's license on inactive status.

    3. Failure to timely renew the physician's license, or

    4. Restriction of the physician's ability to prescribe or administer medication, including loss or expiration of a physician's Drug Enforcement Administration Certificate of Registration.

  4. A physician denied registration may request a hearing to appeal the decision by filing the request, in writing, with the Board, not later than 10 days after receipt of the notice denying the registration.


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