Ariz. Admin. Code § 4-19-513

Current through Register Vol. 30, No. 45, November 8, 2024

Section R4-19-513 - Dispensing Drugs and Devices

A. An RNP, CNM, or CNS granted prescribing and dispensing authority by the Board may, within restrictions provided by law and applicable to each certificate:

1. Dispense drugs and devices to patients;

2. Dispense samples of drugs packaged for individual use without a prescription order or additional labeling;

3. Only dispense drugs and devices obtained directly from a pharmacy, manufacturer, wholesaler, or distributor; and

4. Allow other personnel to assist in the delivery of medications provided that the RNP, CNM, or CNS retains responsibility and accountability for the dispensing process.

B. If dispensing a drug or device, an RNP, CNM, or CNS with dispensing authority shall:

1. Ensure that the patient has a written prescription that complies with R4-19-512(F) and contains the address of the patient and inform the patient that the prescription may be filled by the prescribing RNP, CNM, or CNS or by a pharmacy of the patient's choice;

2. Affix a prescription number to each prescription that is dispensed;

3. Ensure that all original prescriptions are preserved for a minimum of seven years and make the original prescriptions available at all times for inspection by the Board of Nursing, Board of Pharmacy, and law enforcement officers in performance of their duties; and

4. Report the dispensing of controlled substances to the Board of Pharmacy's Controlled Substance Prescription Monitoring Program according to A.R.S. § 36-2608.

C. An RNP, CNM, or CNS practicing in a public health facility operated by this state or a county or in a qualifying community health center under A.R.S. § 32-1921(D) and (F) may dispense drugs or devices to patients without a written prescription if the public health facility or the qualifying community health center adheres to all storage, labeling, safety, and recordkeeping rules of the Board of Pharmacy.

D. An RNP, CNM, or CNS who dispenses a drug shall ensure that a label is affixed that contains all of the following information:

1. Dispensing RNP's, CNM's, or CNS's name and population focus;

2. Address and telephone number of the location from which the drug is dispensed;

3. Date dispensed;

4. Patient's name and address;

5. Name and strength of the drug, quantity in the container, directions for use, and any cautionary statements necessary for the safe and effective use of the drug;

6. Manufacturer and lot number; and

7. Prescription order number.

E. An RNP, CNM, or CNS who dispenses a drug or device shall ensure that the following information about the drug or device is entered into the patient's medical record:

1. Name of the drug, strength, quantity, directions for use, and number of refills;

2. Date dispensed;

3. Therapeutic reason;

4. Manufacturer and lot number; and

5. Prescription order number.

F. An RNP, CNM, or CNS with dispensing authority shall:

1. Keep all drugs in a locked cabinet or room in an area that is not accessible to patients;

2. If dispensing a controlled substance:

a. Control access by a written policy that specifies:

i. Those persons allowed access, and

ii. Procedures to report immediately the discovery of a shortage or illegal removal of drugs to a local law enforcement agency and provide that agency and the DEA with a written report within seven days of the discovery.

b. Maintain and make available to the Board upon request an ongoing inventory and record of:

i. A Schedule II controlled substance, as defined in the federal Controlled Substances Act or Arizona's Uniform Controlled Substances Act, separately from all other records, and a prescription for a Schedule II controlled substance in a separate prescription file; and

ii. A Schedule III, IV, or V controlled substance, as defined in the federal Controlled Substances Act or Arizona's Uniform Controlled Substances Act, in a form that is readily retrievable from other records.

G. If a prescription order is refilled, an RNP, CNM, or CNS with P & D authority shall record the following information on the back of the prescription order or in the patient's medical record:

1. Date refilled,

2. Quantity dispensed if different from the full amount of the original prescription,

3. RNP's, CNM's, or CNS's name or identifiable initials, and

4. Manufacturer and lot number.

H. Under the supervision of an RNP, CNM, or CNS with P & D authority, other personnel may:

1. Receive and record a prescription refill request from a patient or a patient's representative;

2. Receive and record a verbal refill authorization from the RNP including:

a. The RNP's, CNM's, or CNS's name;

b. Date of refill;

c. Name, directions for use, and quantity of drug; and

d. Manufacturer and lot number;

3. Prepare and affix a prescription label; and

4. Prepare a drug or device for delivery, provided that the dispensing RNP, CNM, or CNS:

a. Inspects the drug or device and initials the label before issuing to the patient to ensure compliance with the prescription; and

b. Ensures that the patient is informed of the name of the drug or device, directions for use, precautions, and storage requirements.

Ariz. Admin. Code § R4-19-513

Adopted effective November 25, 1996 (Supp. 96-4). Amended by final rulemaking at 5 A.A.R. 4300, effective October 18, 1999 (Supp. 99-4). Former R4-19-513 renumbered to R4-19-515; new R4-19-513 renumbered from R4-19-508and amended by final rulemaking at 11 A.A.R. 3804, effective November 12, 2005 (Supp. 05-3). Amended by final rulemaking at 19 A.A.R. 1438, effective July 6, 2013 (Supp. 13-2). Amended by final rulemaking at 26 A.A.R. 3289, effective 12/2/2020.