Chapter 0087 - 532R - S Ver of HB2633

Be it enacted by the Legislature of the State of Arizona:

Section 1. Section 32-3248, Arizona Revised Statutes, as added by Laws 2018, first special session, chapter 1, section 29, is amended to read:

START_STATUTE32-3248. Health professionals; controlled substances; initial prescriptions; limits; exceptions; definition

A. A health professional who is authorized under this title to prescribe controlled substances shall limit the initial prescription for a patient for a schedule II controlled substance that is an opioid to not more than a five‑day supply, except that an initial prescription for a schedule II controlled substance that is an opioid following a surgical procedure is limited to not more than a fourteen‑day supply.

B. Subsection A of this section does not apply to initial prescriptions if the patient:

1. Has an active oncology diagnosis.

2. Has a traumatic injury, not including a surgical procedure.

3. Is receiving hospice care.

4. Is receiving end‑of‑life care.

5. Is receiving palliative care.

6. Is receiving skilled nursing facility care.

7. Is receiving treatment for burns.

8. Is receiving medication‑assisted treatment for a substance use disorder.

9. Is an infant who is being weaned off opioids at the time of hospital discharge.

C. If a health professional's prescribing authority under the relevant chapter of this title for schedule II controlled substances is more restrictive than the limit specified in subsection A of this section, the health professional's prescribing authority under the relevant chapter of this title applies.

D. An initial prescription for a schedule II controlled substance that is an opioid that is written for more than a five‑day supply is deemed to meet the requirements of an exemption under this section when the initial prescription is presented to the dispenser. A pharmacist is not required to verify with the prescriber whether the initial prescription complies with this section.

D. E. For the purposes of this section, "initial prescription" means a prescription for a schedule II controlled substance that is an opioid that has not covered any portion of the past sixty days before the date the pharmacy dispenses the current prescription as evidenced by the controlled substances prescription monitoring program's central database tracking system. END_STATUTE

Sec. 2. Section 32-3248.01, Arizona Revised Statutes, as added by Laws 2018, first special session, chapter 1, section 29, is amended to read:

START_STATUTE32-3248.01. Schedule II controlled substances; dosage limit; exceptions; morphine; opioid antagonist; definition

A. A health professional who is authorized under this title to prescribe controlled substances may not issue a new prescription order for a schedule II controlled substance that is an opioid that exceeds ninety morphine milligram equivalents per day.

B. The limit prescribed by subsection A of this section does not apply to:

1. A continuation of a prior prescription order that was issued within the previous sixty days.

2. An opioid with a maximum approved total daily dose in the labeling as approved by the United States food and drug administration.

3. A patient who:

(a) Has an active oncology diagnosis.

(b) Has a traumatic injury, not including a surgical procedure.

(d) Is receiving end‑of‑life care.

(e) Is receiving palliative care.

(f) Is receiving skilled nursing facility care.

(g) Is receiving treatment for burns.

(h) Is receiving medication‑assisted treatment for a substance use disorder.

(i) Is hospitalized.

C. If a health professional believes that a patient requires more than ninety morphine milligram equivalents per day and the patient is not exempt from the limit pursuant to subsection B of this section, the health professional shall first consult with a physician who is licensed pursuant to chapter 13 or 17 of this title and who is board‑certified in pain. The consultation may be done by telephone or through telemedicine. If the consulting physician is not available to consult within forty‑eight hours after the request, the health professional may prescribe the amount that the health professional believes the patient requires and subsequently have the consultation. If the health professional is a physician who is licensed pursuant to chapter 13 or 17 of this title and is board‑certified in pain, the health professional may issue a prescription order for more than ninety morphine milligram equivalents per day without a consultation under this subsection.

D. If a patient is prescribed more than ninety morphine milligram equivalents per day pursuant to subsection B or C of this section, the prescribing health professional shall also prescribe for the patient naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration for the treatment of opioid‑related overdoses.

E. A prescription order for a schedule II controlled substance that is an opioid that is written for more than ninety morphine milligram equivalents per day is deemed to meet the requirements of an exemption under this section when the prescription order is presented to the dispenser. A pharmacist is not required to verify with the prescriber whether the prescription order complies with this section.

E. F. For the purposes of this section, "prescription order" has the same meaning prescribed in section 32‑1901. END_STATUTE

Sec. 3. Section 36‑2525, Arizona Revised Statutes, as amended by Laws 2018, first special session, chapter 1, section 37, is amended to read:

START_STATUTE36-2525. Prescription orders; labels; packaging; definition

A. In addition to the requirements of section 32‑1968 pertaining to prescription orders for prescription‑only drugs, the prescription order for a controlled substance shall bear the name, address and federal registration number of the prescriber. A prescription order for a schedule II controlled substance drug other than a hospital drug order for a hospital inpatient shall contain only one drug order per prescription blank. If authorized verbally by the prescriber, the pharmacist may make changes to correct errors or omissions made by the prescriber on the following parts of a written or electronic schedule II controlled substance prescription order:

1. The date issued.

2. The strength, dosage form or quantity of drug.

3. The directions for its use.

B. The pharmacist must document on the original prescription order the changes that were made pursuant to the verbal authorization and record the time and date the authorization was granted.

C. A person who is registered to dispense controlled substances under this chapter must keep and maintain prescription orders for controlled substances as follows:

1. Prescription orders for controlled substances listed in schedules I and II must be maintained in a separate prescription file for controlled substances listed in schedules I and II only.

2. Prescription orders for controlled substances listed in schedules III, IV and V must be maintained either in a separate prescription file for controlled substances listed in schedules III, IV and V only or in a form that allows them to be readily retrievable from the other prescription records of the registrant. For the purposes of this paragraph, "readily retrievable" means that, when the prescription is initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" in a font that is not less than one inch high and that the prescription is filed in the usual consecutively numbered prescription file for noncontrolled substance prescriptions. The requirement to stamp the hard copy prescription with a red "C" is waived if a registrant employs an electronic data processing system or other electronic recordkeeping system for prescriptions that permits identification by prescription number and retrieval of original documents by the prescriber's name, patient's name, drug dispensed and date filled.

D. Except in emergency situations in conformity with subsection E of this section, under the conditions specified in subsections F and G of this section or when dispensed directly by a medical practitioner to an ultimate user, a controlled substance in schedule II shall not be dispensed without either the written prescription order in ink or indelible pencil or typewritten and manually signed by the medical practitioner or an electronic prescription order as prescribed by federal law or regulation. Beginning January 1, 2019, a schedule II controlled substance that is an opioid may be dispensed in a county with a population of one hundred fifty thousand persons or more only with an electronic prescription order as prescribed by federal law or regulation. Beginning July 1, 2019, a schedule II controlled substance that is an opioid may be dispensed in a county with a population of less than one hundred fifty thousand persons only with an electronic prescription order as prescribed by federal law or regulation. A prescription order for a schedule II substance shall not be dispensed more than ninety days after the date on which the prescription order was issued. NOTWITHSTANDING ANY OTHER PROVISION OF THIS SECTION, a limited service pharmacy as defined in section 32‑1901 may sell and dispense a schedule II controlled substance prescribed by a medical practitioner who is located in another county in this state or in another state if the prescription was issued to the patient according to and in compliance with the applicable laws of the state of the prescribing medical practitioner and federal law. A prescription order for a schedule II controlled substance shall not be refilled.

E. In emergency situations, emergency quantities of schedule II controlled substances may be dispensed on an oral prescription order of a medical practitioner. Such an emergency prescription order shall be immediately reduced to writing by the pharmacist and shall contain all the information required for schedule II controlled substances except for the manual signing of the order by the medical practitioner. Within seven days after authorizing an emergency oral prescription order, the prescribing medical practitioner shall cause a written prescription order manually signed for the emergency quantity prescribed to be delivered to the dispensing pharmacist or an electronic prescription order to be transmitted to the dispensing pharmacist. In addition to conforming to other requirements for prescription orders for schedule II controlled substances, the prescription order shall indicate electronically or have written on its face "authorization for emergency dispensing" and the date of the oral order. If the prescribing medical practitioner fails to deliver such an emergency prescription order within seven days in conformance with board rules, the pharmacist shall notify the board. Failure of the pharmacist to notify the board voids the authority conferred by this subsection to dispense without a prescription order of a medical practitioner that is electronic or that is written and manually signed.

F. The following may be transmitted to a pharmacy by fax by a patient's medical practitioner or the medical practitioner's agent:

1. A prescription order written for a schedule II controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion.

2. A prescription order written for any schedule II controlled substance for a resident of a long-term care facility.

3. A prescription order written for a schedule II controlled substance for a patient enrolled in a hospice care program that is certified or paid for by medicare under title XVIII or a hospice program that is licensed by this state. The medical practitioner or the medical practitioner's agent must note on the prescription that the patient is a hospice patient.

G. A fax transmitted pursuant to subsection F of this section is the original written prescription order for purposes of this section and must be maintained as required by subsection C of this section.

H. Except when dispensed directly by a medical practitioner to an ultimate user, a controlled substance included in schedule III or IV that requires a prescription order as determined under state or federal laws shall not be dispensed without a written or oral prescription order of a medical practitioner or an electronic prescription order as prescribed by federal law or regulation. The prescription order shall not be filled or refilled more than six months after the date on which the prescription order was issued. A prescription order authorized to be refilled shall not be refilled more than five times. Additional quantities may only be authorized by the prescribing medical practitioner through issuance of a new prescription order that shall be treated by the pharmacist as a new and separate prescription order.

I. Except when dispensed directly by a medical practitioner to an ultimate user, a controlled substance that is included in schedule V and that requires a prescription order as determined under state or federal laws shall not be dispensed without a written or oral prescription order of a medical practitioner. The prescription order may be refilled as authorized by the prescribing medical practitioner but shall not be filled or refilled more than one year after the date of issuance.

J. A controlled substance that is listed in schedule III, IV or V and that does not require a prescription order as determined under state or federal laws may be dispensed at retail by a pharmacist, a pharmacy intern or a graduate intern under the pharmacist's supervision without a prescription order to a purchaser who is at least eighteen years of age if all of the following are true:

1. It is for a legitimate medical purpose.

2. Not more than two hundred forty cubic centimeters (eight ounces) of any such controlled substance containing opium, nor more than one hundred twenty cubic centimeters (four ounces) of any other such controlled substance, nor more than forty‑eight dosage units of any such controlled substance containing opium, nor more than twenty‑four dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given forty‑eight-hour period.

3. No more than one hundred dosage units of any single active ingredient ephedrine preparation may be sold, offered for sale, bartered or given away to any one person in any one thirty‑day period.

4. The pharmacist, pharmacy intern or graduate intern requires every purchaser of a controlled substance under this subsection who is not known to that person to furnish suitable identification, including proof of age if appropriate.

5. A bound record book for dispensing controlled substances under this subsection is maintained by the pharmacist and contains the name and address of the purchaser, the name and quantity of the controlled substance purchased, the date of each purchase and the name or initials of the pharmacist, pharmacy intern or graduate intern who dispensed the substance to the purchaser. The book shall be maintained in conformity with the recordkeeping requirements of section 36‑2523.

K. In the absence of a law requiring a prescription for a schedule V controlled substance, the board, by rules, may require, or remove the requirement of, a prescription order for a schedule V controlled substance.

L. The label on a container of a controlled substance that is directly dispensed by a medical practitioner or pharmacist and that is not for the immediate administration to the ultimate user, such as a bed patient in a hospital, shall bear the name and address of the dispensing medical practitioner or pharmacist, the serial number, the date of dispensing, the name of the prescriber, the name of the patient or, if an animal, the name of the owner of the animal and the species of the animal, the directions for use and cautionary statements, if any, contained in the prescription order or required by law. If the controlled substance is included in schedule II, III or IV, the label shall bear a transfer warning to the effect: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed". The container of a schedule II controlled substance that is an opioid that is directly dispensed by a pharmacist and that is not for the immediate administration to the ultimate user shall have a red cap and a warning label prescribed by the board about potential addiction. The board or the executive director, if delegated by the board, may waive the red cap requirement if implementing the requirement is not feasible because of the specific dosage form or packaging type.

M. Controlled substances in schedules II, III, IV and V may be dispensed as electronically transmitted prescriptions if the prescribing medical practitioner is all of the following:

1. Properly registered by the United States drug enforcement administration.

2. Licensed in good standing in the United States jurisdiction in which the medical practitioner practices.

3. Authorized to issue such prescriptions in the jurisdiction in which the medical practitioner is licensed.

N. Notwithstanding any other provision of this section, beginning January 1, 2019, each prescription order that is issued by a medical practitioner in a county with a population of one hundred fifty thousand persons or more for a schedule II controlled substance that is an opioid shall be transmitted electronically to the dispensing pharmacy. Notwithstanding any other provision of this section, beginning July 1, 2019, each prescription order that is issued by a medical practitioner in a county with a population of less than one hundred fifty thousand persons for a schedule II controlled substance that is an opioid shall be transmitted electronically to the dispensing pharmacy.

O. The requirement in subsections D and N of this section for an electronic prescription order does not apply to a prescription order for a schedule II controlled substance that is an opioid that is issued for medication-assisted treatment for a substance use disorder.

P. The board, by rule, may provide additional requirements for prescribing and dispensing controlled substances.

Q. The board shall establish a process to grant a waiver for the requirement in subsections D and N of this section for electronic prescription orders to a medical practitioner who lacks adequate access to broadband or faces other hardships that prevent the medical practitioner from implementing electronic prescription orders. A pharmacist is not required to verify with a medical practitioner or the board whether the medical practitioner has received a waiver pursuant to this subsection.

R. For the purposes of this section, "medication‑assisted treatment" has the same meaning prescribed in section 32‑3201.01. END_STATUTE

Sec. 4. Retroactivity

This act applies retroactively to from and after April 25, 2018.