Ariz. Admin. Code § 4-22-302

Current through Register Vol. 30, No. 50, December 13, 2024

Section R4-22-302 - Packaging and Inventory

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.

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

1. The name, address, and telephone number of the dispensing osteopathic physician;

2. The date the controlled substance or prescription-only drug is dispensed;

3. The patient's name;

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 used of the controlled substance or prescription-only drug; and

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.

C. An osteopathic physician shall:

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

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

a. Designation of the persons who have access to the locked cabinet or room, and

b. Procedures for recording requests for access to the locked cabinet or room;

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. Store prescription-only drugs so they are not accessible to patients; and

5. Store controlled substances and prescription-only drugs not requiring refrigeration in an area where the temperature does not exceed 85° F.

D. An osteopathic physician shall maintain a dispensing log for all controlled substances and the prescription-only drug nal-buphine 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. Date the drug is dispensed;

2. Patient's name;

3. Name of controlled substance or prescription-only drug, strength, dosage, form, and name of manufacturer;

4. Number of dosage units dispensed;

5. Running total of each controlled substance or prescription-only drug dispensed; and

6. Written signature of the osteopathic physician next to each entry.

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.

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.

Ariz. Admin. Code § R4-22-302

New Section made by final rulemaking at 20 A.A.R. 2655, effective 11/8/2014.