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

A.      A physician shall dispense all controlled substances and pre- scription-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. § 32-1901(49) and state and federal law, unless a patient or a patient’s representative requests a non-safety cap.

B.       All controlled substances and prescription-only drugs dis- pensed shall be labeled with the following information:

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

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

3.        The patient’s name;

4.        The controlled substance and prescription-only drug name, strength, and dosage, form, name of manufacturer, the quantity dispensed, directions for use, and any cau- tionary statement necessary for the safe and effective use of the controlled substance and 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 shall control access to the cabinet or room by a written procedure that includes, at a minimum, designa- tion of the persons who have access to the cabinet or room and procedures for recording requests for access to the cabinet or room. This written procedure shall be made available on demand to the Board or its authorized representatives for inspection or copying. Prescription-only drugs shall be stored so as not to be accessible to patients.

D.      Controlled substances and prescription-only drugs not requir- ing refrigeration shall be maintained in an area where the tem- perature does not exceed 85° F.

E.       A physician shall maintain an ongoing dispensing log for all controlled substances and the prescription-only drug nalbu- phine 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;

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

5.        The number of dosage units dispensed;

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

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

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

G.      This Section does not apply to a prepackaged manufacturer sample of a controlled substance and prescription-only drug, unless otherwise provided by federal law.

Historical Note

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 R4-16-202 at 11 A.A.R.

1283, effective March 25, 2005 (Supp. 05-1).