Ariz. Admin. Code § 4-16-302

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

Section R4-16-302 - Packaging and Inventory; Exception

A. A physician shall dispense all controlled substances and prescription-only drugs in prepackaged containers or in light-resistant containers with consumer safety caps that comply with standards specified in the official compendium, as defined in A.R.S. § 321901, and state and federal law, unless a patient or the patient's representative requests a non-safety cap.

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

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

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

3. The patient's name and date of birth;

4. The controlled substance or prescription-only drug name, strength, dosage, form, name of manufacturer, the 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. 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. A physician shall secure all controlled substances in a locked cabinet or room and control access to the cabinet or room by a written procedure that includes, at a minimum, designation of the persons who have access to the cabinet or room and procedures for recording requests for access to the cabinet or room. The physician shall make the written procedure available on demand to the Board or its authorized representatives for inspection or copying.

D. A physician shall store prescription-only drugs so the prescription-only drugs are not accessible to patients.

E. A physician shall store controlled substances and prescription-only drugs not requiring refrigeration in an area where the temperature does not exceed 85° F.

F. A physician shall maintain an ongoing dispensing log for all controlled substances and the prescription-only drug nalbuphine hydrochloride (Nubain) dispensed by the physician. The dispensing log shall include the following:

1. A separate inventory sheet for each controlled substance and prescription-only drug;

2. The date the drug is dispensed;

3. The patient's name and date of birth;

4. The controlled substance or prescription-only drug name, strength, dosage, form, and name of the manufacturer;

5. The number of dosage units dispensed;

6. A running total of each controlled substance and prescription-only drug dispensed; and

7. The signature of the physician written next to each entry.

G. A physician may use a computer to maintain the dispensing log required in subsection (F) if the dispensing log is password protected and quickly accessible through either on-screen viewing or printing a copy.

H. 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 § R4-16-302

New Section adopted by final rulemaking at 6 A.A.R. 751, effective February 2, 2000 (Supp. 00-1). Former Section R4-16-302 recodified to R4-16-402; New Section R4-16-302 recodified from R4-16-202at 11 A.A.R. 1283, effective March 25, 2005 (Supp. 05-1). Amended by final rulemaking at 27 A.A.R. 2907, effective 2/6/2022.