Ariz. Admin. Code § 4-23-407

Current through Register Vol. 30, No. 44, November 1, 2024

Section R4-23-407 - Prescription Requirements

A. Prescription orders. A pharmacist shall ensure that:

1. A prescription order the pharmacist uses to dispense a drug or device includes the following information:

a. Date of issuance;

b. Name and address of the patient for whom or the owner of the animal for which the drug or device is dispensed;

c. Drug name, strength, and dosage form or device name;

d. Name of the manufacturer or distributor of the drug or device if the prescription order is written generically or a substitution is made;

e. Prescribing medical practitioner's directions for use;

f. Date of dispensing;

g. Quantity prescribed and if different, quantity dispensed;

h. For a prescription order for a controlled substance, the medical practitioner's address and DEA number;

i. For a written prescription order, the medical practitioner's signature;

j. For an electronically transmitted prescription order, the medical practitioner's digital or electronic signature;

k. For an oral prescription order, the medical practitioner's name and telephone number; and

l. Name or initials of the dispensing pharmacist;

2. A prescription order is kept by the pharmacist or pharmacy permittee as a record of the dispensing of a drug or device for seven years from the date the drug or device is dispensed;

3. The dispensing of a drug or device complies with the packaging requirements of the official compendium and state and federal law; and

4. If the drug dispensed is a schedule II controlled substance that is an opioid, the drug is placed in a container that has a red cap and a warning label stating "CAUTION: OPIOID, Risk of Overdose and Addiction" or other similarly clear language indicating the possibility of overdose and addiction. Under delegation from the Board, the Executive Director may waive the red-cap requirement if implementing the requirement is not feasible because of the specific dosage form or packaging type.

B. Prescription refills. A pharmacist shall ensure that the following information is recorded on the back of a prescription order when it is refilled:

1. Date refilled,

2. Quantity dispensed,

3. Name or approved abbreviation of the manufacturer or distributor if the prescription order is written generically or a substitution is made, and

4. The name or initials of the dispensing pharmacist.

C. Prescription order adaptation. Except for a prescription order for a controlled substance, a pharmacist, using professional judgment, may make the following adaptations to a prescription order if the pharmacist documents the adaptation in the patient's record:

1. Change the prescribed quantity if the prescribed quantity is not a package size commercially available from the manufacturer;

2. Change the prescribed dosage form or directions for use if the change achieves the intent of the prescribing medical practitioner;

3. Complete missing information on the prescription order if there is sufficient evidence to support the change; and

4. Extend the quantity of a maintenance drug for the limited quantity necessary to achieve medication refill synchronization for the patient.

D. A pharmacist may furnish a copy of a prescription order to the patient for whom it is prescribed or to the authorized representative of the patient if the copy is clearly marked "COPY FOR REFERENCE PURPOSES ONLY" or other similar statement. A copy of a prescription order is not a valid prescription order and a pharmacist shall not dispense a drug or device from the information on a copy.

E. Transfer of prescription order information. For a transfer of prescription order information to be valid, a pharmacy permittee or pharmacist-in-charge shall ensure that:

1. Both the original and the transferred prescription order are maintained for seven years after the last dispensing date;

2. The original prescription order information for a Schedule III, I V, or V controlled substance is transferred only as specified in 21 CFR 1306.25;

3. The original prescription order information for a non-controlled substance drug is transferred without limitation only up to the number of originally authorized refills;

4. For a transfer within Arizona:

a. The transfer of original prescription order information for a non-controlled substance drug meets the following conditions:

i. The transfer of information is communicated electronically, verbally, or by fax directly between:

(1) Two licensed pharmacists,

(2) A licensed pharmacist and a licensed intern, or

(3) Two licensed interns;

ii. The following information is recorded by the transferring pharmacist or intern:

(1) The word "void" is written on the face of the invalidated original prescription unless it is an electronic or oral transfer and the transferred prescription order information is invalidated in the transferring pharmacy's computer system; and

(2) The name and identification code, number, or address and telephone number of the pharmacy to which the prescription is transferred, the name of the receiving pharmacist or intern, the date of transfer, and the name of the transferring pharmacist or intern is written on the back of the prescription or entered into the transferring pharmacy's computer system; and

iii. The following information is recorded by the receiving pharmacist or intern on the transferred prescription order:

(1) The word "transfer;"

(2) Date of issuance of the original prescription order;

(3) Original number of refills authorized on the original prescription order;

(4) Date of original dispensing;

(5) Number of valid refills remaining and the date of the last refill;

(6) Name and identification code, number, or address, telephone number, and original prescription number of the pharmacy from which the prescription is transferred;

(7) Name of the transferring pharmacist or intern; and

(8) Name of the receiving pharmacist or intern;

b. The transfer of original prescription order information for a Schedule III, I V, or controlled substance meets the following conditions:

i. The transfer of information is communicated directly between two licensed pharmacists or interns electronically or verbally;

ii. The following information is recorded by the transferring pharmacist or intern:

(1) The word "void" is written on the face of the invalidated original prescription order unless it is an electronic or oral transfer and the transferred prescription order information is invalidated in the transferring pharmacy's computer system; and

(2) The name, address, and DEA number of the pharmacy to which the prescription is transferred, the name of the receiving pharmacist, the date of transfer, and the name of the transferring pharmacist is written on the back of the prescription order or entered into the transferring pharmacy's computer system; and

iii. The following information is recorded by the receiving pharmacist on the transferred prescription order:

(1) The word "transfer;"

(2) Date of issuance of original prescription order;

(3) Original number of refills authorized on the original prescription order;

(4) Date of original dispensing;

(5) Number of valid refills remaining and the date of the last refill;

(6) Name, address, DEA number, and original prescription number of the pharmacy from which the prescription is transferred;

(7) Name of the transferring pharmacist; and

(8) Name of the receiving pharmacist;

5. For a transfer from out-of-state:

a. The transfer of original prescription order information for a non-controlled substance drug meets the conditions in subsections (E)(4)(a)(i) and (E)(4)(a)(iii); and

b. The transfer of original prescription order information for a Schedule III, I V, or V controlled substance meets the conditions in subsections (E)(4)(b)(i) and (E)(4)(b)(iii); and

6. For an electronic transfer, the electronic transfer of original prescription order information meets the following conditions:

a. The electronic transfer is between pharmacies owned by the same company using a common or shared database;

b. The electronic transfer of original prescription order information for a non-controlled substance drug is performed by a pharmacist or intern, pharmacy technician trainee, or pharmacy technician under the supervision of a pharmacist;

c. The electronic transfer of original prescription order information for a controlled substance is performed between two licensed pharmacists;

d. The electronic transfer of original prescription order information for a non-controlled substance drug meets the following conditions:

i. The transferring pharmacy's computer system:

(1) Invalidates the transferred original prescription order information;

(2) Records the identification code, number, or address of the pharmacy to which the prescription order information is transferred;

(3) Records the name or identification code of the receiving pharmacist, intern, pharmacy technician trainee, or pharmacy technician; and

(4) Records the date of transfer; and

ii. The receiving pharmacy's computer system;

(1) Records that a prescription transfer occurred;

(2) Records the date of issuance of the original prescription order;

(3) Records the original number of refills authorized on the original prescription order;

(4) Records the date of original dispensing;

(5) Records the number of valid refills remaining and the date of the last refill;

(6) Records the identification code, number, or address and original prescription number of the pharmacy from which the prescription is transferred;

(7) Records the name or identification code of the receiving pharmacist or intern, pharmacy technician trainee, or pharmacy technician; and

(8) Records the date of transfer;

e. The electronic transfer of original prescription order information for a controlled substance meets the following conditions:

i. The transferring pharmacy's computer system:

(1) Invalidates the transferred original prescription order information;

(2) Records the identification code, number, or address, and DEA number of the pharmacy to which the prescription order information is transferred;

(3) Records the name or identification code of the receiving pharmacist;

(4) Records the date of transfer; and

(5) Records the name or identification code of the transferring pharmacist; and

ii. The electronic prescription order information received by the computer system of the receiving pharmacy includes the information required in subsection (E)(4)(b)(iii); and

f. In addition to electronic documentation of a transferred prescription order in the computer system, an original prescription order containing the requirements of this Section is filed in compliance with A.R.S. § 32-1964.

F. Transmission of a prescription order from a medical practitioner to a pharmacy by fax.

1. A medical practitioner or medical practitioner's agent may transmit a prescription order for a Schedule III, I V, or V controlled substance, prescription-only drug, or nonprescription drug to a pharmacy by fax under the following conditions:

a. The prescription order is faxed only to the pharmacy of the patient's choice;

b. The faxed prescription order:

i. Contains all the information required for a prescription order in A.R.S. §§ 32-1968 and 36-2525; and

ii. Is only faxed from the medical practitioner's practice location, except that a nurse in a hospital, long-term care facility, or inpatient hospice may send a fax of a prescription order for a patient of the facility; and

c. The faxed prescription order shall contain the following additional information:

i. The date the prescription order is faxed;

ii. The fax number of the prescribing medical practitioner or the facility from which the prescription order is faxed, and the telephone number of the facility; and

iii. The name of the person who transmits the fax, if other than the medical practitioner.

2. A medical practitioner or medical practitioner's agent may fax a prescription order for a Schedule II controlled substance for information purposes only, unless the faxed prescription order meets the requirements of A.R.S. § 36-2525(F) and (G).

3. A pharmacy may receive a faxed prescription order for a Schedule II controlled substance for information purposes only, except a faxed prescription order for a Schedule II controlled substance that meets the requirements of A.R.S. § 36-2525(F) and (G) may serve as the original written prescription order.

4. To meet the seven-year record retention requirement of A.R.S. § 32-1964, a pharmacy shall receive a faxed prescription order on plain paper or may make a photocopy of the faxed prescription order.

5. A medical practitioner or the medical practitioner's agent may fax refill authorizations to a pharmacy if the faxed authorization includes the medical practitioner's telephone and fax numbers, the medical practitioner's signature or medical practitioner's agent's name, and date of authorization.

G. Electronic transmission of a prescription order from a medical practitioner to a pharmacy.

1. Unless otherwise prohibited by law, a medical practitioner or medical practitioner's agent may transmit a prescription order by electronic means, directly or through an intermediary, including an E-prescribing network, to the dispensing pharmacy as specified in A.R.S. § 32-1968.

2. For electronic transmission of a Schedule II, III, I V, or V controlled substance prescription order, the medical practitioner and pharmacy shall ensure the transmission complies with any security or other requirements of federal law.

3. The medical practitioner and pharmacy shall ensure all electronic transmissions comply with all the security requirements of state or federal law related to the privacy of protected health information.

4. In addition to the information required to be included on a prescription order as specified in A.R.S. § 32-1968, a medical practitioner shall ensure an electronically transmitted prescription order includes:

a. The date of transmission; and

b. If the individual transmitting the prescription is not the medical practitioner, the name of the medical practitioner's authorized agent who transmits the prescription order.

5. A pharmacy receiving an electronically transmitted prescription order shall maintain the prescription order as specified in A.R.S. § 32-1964 or R4-23-408(H)(2).

6. A medical practitioner or medical practitioner's agent shall transmit an electronic prescription order only to the pharmacy of the patient's choice.

H. Exceptions under A.R.S. § 36-2525 regarding electronic prescribing requirements:

1. Medical practitioner exceptions. A medical practitioner who is authorized to prescribe a controlled substance may furnish a written prescription order is accordance with R4-23-407 rather than an electronically transmitted prescription order if the prescription order is written:

a. In this state to be filled in a jurisdiction outside this state;

b. For a medication that requires compounding two or more ingredients;

c. For a medication that is not in the E-prescribing database;

d. For an individual who is detained by or in custody of an Arizona or federal law enforcement agency; or

e. Under A.R.S. § 36-2525(N) or (O); and

2. Pharmacist exceptions. A pharmacist may dispense a controlled substance from a written rather than electronically transmitted prescription order if the prescription order:

a. Is written by a medical practitioner who is not licensed in this state but rather, is licensed in a jurisdiction outside this state. The pharmacist is not required to verify whether the medical practitioner is licensed;

b. Is written for a medication that requires compounding two or more ingredients;

c. Is written for a medication that is not in the E-prescribing database;

d. Is written for an individual who is detained by or in custody of an Arizona or federal law enforcement agency; or

e. Is received under A.R.S. § 36-2525(D).

Ariz. Admin. Code § R4-23-407

Adopted effective November 18, 1983 (Supp. 83-6). Amended by final rulemaking at 8 A.A.R. 1256, effective March 7, 2002 (Supp. 02-1). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 13 A.A.R. 440, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at 14 A.A.R. 3605, effective November 8, 2008 (Supp. 08-3). Amended by final rulemaking at 25 A.A.R. 1015, effective 6/1/2019. Amended by final rulemaking at 26 A.A.R. 223, effective 3/14/2020. Amended by final rulemaking at 26 A.A.R. 544, effective 3/3/2020.