Bill Text: AZ SB1254 | 2023 | Fifty-sixth Legislature 1st Regular | Engrossed
Bill Title: Opioids; containers; labeling; requirements; repeal
Spectrum: Partisan Bill (Republican 5-0)
Status: (Engrossed - Dead) 2023-05-15 - House third reading FAILED voting: (20-38-1-0) [SB1254 Detail]
Download: Arizona-2023-SB1254-Engrossed.html
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House Engrossed Senate Bill
opioids; containers; labeling; requirements; repeal |
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State of Arizona Senate Fifty-sixth Legislature First Regular Session 2023
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SENATE BILL 1254 |
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An Act
amending section 36-2525, Arizona Revised Statutes; relating to controlled substances.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Section 36-2525, Arizona Revised Statutes, is amended to read:
36-2525. Prescription orders; labels; recordkeeping; 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 a written or electronic schedule II controlled substance prescription order, except for any of the following:
1. The patient's name.
2. The prescriber's name.
3. The drug name.
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 at least 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 allows 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, 2020, A schedule II controlled substance that is an opioid may be dispensed only with an electronic prescription order as prescribed by federal law or regulation. A prescription order for a schedule II controlled 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 pharmacy may sell and dispense a schedule II controlled substance prescribed by a medical practitioner who is located 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. A pharmacist is not in violation of this subsection and may dispense a prescription order in the following circumstances:
1. During any time period in which an established electronic prescribing system or a pharmacy management system is not operational or available in a timely manner. If the electronic prescribing system or a pharmacy management system is not operational or available, the pharmacist may dispense a prescription order that is written for a schedule II controlled substance that is an opioid. The pharmacist must maintain a record, for a period of time prescribed by the board, of when the electronic prescribing system or pharmacy management system is not operational or available in a timely manner.
2. The prescription order for a schedule II controlled substance that is an opioid is in writing and indicates that the medical practitioner who issued the prescription order provided care for the patient in a veterans administration facility, a health facility on a military base, an Indian health services hospital or other Indian health service facility, or a tribal-owned clinic.
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. Notwithstanding subsections D and N of this section, a patient's medical practitioner or the medical practitioner's agent may transmit to a pharmacy by fax a prescription order written for a schedule II controlled substance, including opioids, if the prescription order is any of the following:
1. To be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion.
2. For a resident of a long-term care facility.
3. For a patient who is 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 or a pharmacy 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 not 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 or pharmacy 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 or pharmacy 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 may have a red cap and shall have 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, 2020, each prescription order, except a prescription order under subsection F of this section, that is issued by a medical practitioner for a schedule II controlled substance that is an opioid shall be transmitted electronically to the dispensing pharmacy. A medical practitioner is not in violation of this subsection:
1. During any time in which an established electronic prescribing system or a pharmacy management system is not operational or available in a timely manner. If the electronic prescribing system or a pharmacy management system is not operational or available, the medical practitioner may write a prescription order for a schedule II controlled substance that is an opioid. The medical practitioner shall indicate on the written prescription order that the electronic prescribing system or pharmacy management system is not operational or available. The medical practitioner must maintain a record, for a period of time prescribed by the board, of when the electronic prescribing system or pharmacy management system is not operational or available in a timely manner.
2. If the medical practitioner writes a prescription order for a schedule II controlled substance that is an opioid that will be dispensed for the patient from a veterans administration facility, a health facility on a military base, an Indian health services hospital or other Indian health service facility, or a tribal-owned clinic.
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. In consultation with the task force established pursuant to section 36-2603, the board may prescribe by rule additional exceptions to the electronic prescribing requirements specified in this section for both pharmacists and medical practitioners.
R. Notwithstanding subsections D and N of this section, a medical practitioner who is licensed pursuant to title 32, chapter 21 is not required to comply with the electronic prescribing requirements of subsections D and N of this section until the Arizona state veterinary medical examining board determines that electronic prescribing software is widely available for veterinarians and notifies the Arizona state board of pharmacy of that determination.
S. For the purposes of this section, "medication-assisted treatment" has the same meaning prescribed in section 32-3201.01.
