Packaging and Inventory

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 stan- container with a consumer safety cap that complies with dards specified in the official compendium, as defined at A.R.S. § 32-1901(55), and state and federal law, unless a 22-1 March 31, 2022 4 A.A.C. 22 Arizona CHAPTER 22. BOARD OF OSTEOPATHIC patient or the patient’s representative requests a non-safety cap. con- B. An osteopathic physician shall ensure that a dispensed trolled substance or prescription-only drug is labeled with the following information: dispens- 1. The name, address, and telephone number of the ing 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 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. 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 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. 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. Historical Note New Section made by final rulemaking at 20 A.A.R. 2654, effective November 8, 2014 (Supp. 14-3).