1. A. An osteopathic physician shall dispense a controlled substance or prescription-only drug in a prepackaged or light-resistant container with a consumer safety cap that complies with standards specified in the official compendium, as defined at A.R.S. § 32-1901(55), and state and federal law, unless a patient or the patient’s representative requests a non-safety cap.

2. B. An osteopathic physician shall ensure that a dispensed controlled substance or prescription-only drug is labeled with the following information:

   1. 1. The name, address, and telephone number of the dispensing osteopathic physician;
   2. 2. The date the controlled substance or prescription-only drug is dispensed;
   3. 3. The patient’s name;
   4. 4. The name of the controlled substance or prescription-only drug, strength, dosage, form, name of manufacturer, quantity dispensed, directions for use, and any cautionary statement necessary for the safe and effective use of the controlled substance or prescription-only drug; and
   5. 5. A beyond-use date not to exceed one year from the date of dispensing or the manufacturer’s expiration date if less than one year.

3. C. An osteopathic physician shall:

   1. 1. Secure all controlled substances in a locked cabinet or room;

   2. 2. Control access to the locked cabinet or room by a written procedure that includes, at a minimum:

      1. a. Designation of the persons who have access to the locked cabinet or room, and
      2. b. Procedures for recording requests for access to the locked cabinet or room;
   3. 3. Make the written procedure required under subsection (C)(2) available on demand by the Board or its authorized representative for inspection or copying;
   4. 4. Store prescription-only drugs so they are not accessible to patients; and
   5. 5. Store controlled substances and prescription-only drugs not requiring refrigeration in an area where the temperature does not exceed 85° F.

4. D. An osteopathic physician shall maintain a dispensing log for all controlled substances and the prescription-only drug nalbuphine hydrochloride (Nubain) dispensed. The osteopathic physician shall ensure that the dispensing log includes the following information on a separate inventory sheet for each controlled substance or prescription-only drug:

   1. 1. Date the drug is dispensed;
   2. 2. Patient’s name;
   3. 3. Name of controlled substance or prescription-only drug, strength, dosage, form, and name of manufacturer;
   4. 4. Number of dosage units dispensed;
   5. 5. Running total of each controlled substance or prescription-only drug dispensed; and
   6. 6. Written signature of the osteopathic physician next to each entry.
5. E. An osteopathic physician may use a computer to maintain the dispensing log required under subsection (D) if the log is quickly accessible through either on-screen viewing or printing a copy.
6. F. This Section does not apply to a prepackaged manufacturer sample of a controlled substance or prescription-only drug unless otherwise provided by federal law.

Historical Note

New Section made by final rulemaking at 20 A.A.R. 2654, effective November 8, 2014 (Supp. 14-3).