Bill Text: AZ SB1103 | 2019 | Fifty-fourth Legislature 1st Regular | Chaptered
Bill Title: Pharmacy board; authority; modifications
Spectrum: Partisan Bill (Republican 1-0)
Status: (Passed) 2019-05-25 - Chapter 257 [SB1103 Detail]
Download: Arizona-2019-SB1103-Chaptered.html
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House Engrossed Senate Bill |
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State of Arizona Senate Fifty-fourth Legislature First Regular Session 2019
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CHAPTER 257
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SENATE BILL 1103 |
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AN ACT
Amending section 32‑1904, Arizona Revised Statutes; amending title 32, chapter 18, article 2, Arizona Revised Statutes, by adding section 32‑1921.01; Amending sections 32‑1940, 32‑1961 and 32‑1968, Arizona Revised Statutes; repealing section 32-1971, Arizona Revised Statutes; amending sections 32‑1977, 32-3248.02 and 36‑2525, Arizona Revised Statutes; relating to the Arizona state board of pharmacy.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Section 32-1904, Arizona Revised Statutes, is amended to read:
32-1904. Powers and duties of board; immunity
A. The board shall:
1. Make bylaws and adopt rules that are necessary for the protection of to protect the public and that pertain to the practice of pharmacy, the manufacturing, wholesaling or supplying of drugs, devices, poisons or hazardous substances, the use of pharmacy technicians and support personnel and the lawful performance of its duties.
2. Fix standards and requirements for the registration to register and reregistration of reregister pharmacies, except as otherwise specified.
3. Investigate compliance as to the quality, label and labeling of all drugs, devices, poisons or hazardous substances and take action necessary to prevent the sale of these if they do not conform to the standards prescribed in this chapter, the official compendium or the federal act.
4. Enforce its rules. In so doing, the board or its agents have free access, at all reasonable during the hours reported with the board or the posted hours at the facility, to any pharmacy, manufacturer, wholesaler, third‑party logistics provider, nonprescription drug permittee or other establishment in which drugs, devices, poisons or hazardous substances are manufactured, processed, packed or held, or to enter any vehicle being used to transport or hold such drugs, devices, poisons or hazardous substances for the purpose of:
(a) Inspecting the establishment or vehicle to determine if whether any provisions of this chapter or the federal act are being violated.
(b) Securing samples or specimens of any drug, device, poison or hazardous substance after paying or offering to pay for such the sample.
(c) Detaining or embargoing a drug, device, poison or hazardous substance in accordance with section 32‑1994.
5. Examine and license as pharmacists and pharmacy interns all qualified applicants as provided by this chapter.
6. Require each applicant for an initial license to apply for a fingerprint clearance card pursuant to section 41‑1758.03. If an applicant is issued a valid fingerprint clearance card, the applicant shall submit the valid fingerprint clearance card to the board with the completed application. If an applicant applies for a fingerprint clearance card and is denied, the applicant may request that the board consider the application for licensure notwithstanding the absence of a valid fingerprint clearance card. The board, in its discretion, may approve an application for licensure despite the denial of a valid fingerprint clearance card if the board determines that the applicant's criminal history information on which the denial was based does not alone disqualify the applicant from licensure.
7. Issue duplicates of lost or destroyed permits on the payment of a fee as prescribed by the board.
8. Adopt rules for the rehabilitation of to rehabilitate pharmacists and pharmacy interns as provided by this chapter.
9. At least once every three months, notify pharmacies regulated pursuant to this chapter of any modifications on prescription writing privileges of podiatrists, dentists, doctors of medicine, registered nurse practitioners, osteopathic physicians, veterinarians, physician assistants, optometrists and homeopathic physicians of which it receives notification from the state board of podiatry examiners, state board of dental examiners, Arizona medical board, Arizona state board of nursing, Arizona board of osteopathic examiners in medicine and surgery, Arizona state veterinary medical examining board, Arizona regulatory board of physician assistants, state board of optometry or board of homeopathic and integrated medicine examiners.
10. Charge a permittee a fee, as determined by the board, for an inspection if the permittee requests the Inspection.
11. Issue only one active or open license per individual.
12. Allow a licensee to regress to a lower level license on written explanation and review by the board for discussion, determination and possible action.
B. The board may:
1. Employ chemists, compliance officers, clerical help and other employees subject to title 41, chapter 4, article 4 and provide laboratory facilities for the proper conduct of its business.
2. Provide, by education of educating and information to informing the licensees and to the public, assistance in the curtailment of curtailing abuse in the use of drugs, devices, poisons and hazardous substances.
3. Approve or reject the manner of storage and security of drugs, devices, poisons and hazardous substances.
4. Accept monies and services to assist in the enforcement of enforcing this chapter from other than licensees:
(a) For performing inspections and other board functions.
(b) For the cost of copies of the pharmacy and controlled substances laws, the annual report of the board and other information from the board.
5. Adopt rules for professional conduct appropriate to the establishment and maintenance of a high standard of integrity and dignity in the profession of pharmacy.
6. Grant permission to deviate from a state requirement for experimentation and technological advances.
7. Adopt rules for the training and practice of pharmacy interns, pharmacy technicians and support personnel.
8. Investigate alleged violations of this chapter, conduct hearings in respect to violations, subpoena witnesses and take such action as it deems necessary to revoke or suspend a license or a permit, place a licensee or permittee on probation or warn a licensee or permittee under this chapter or to bring notice of violations to the county attorney of the county in which a violation took place or to the attorney general.
9. By rule, approve colleges or schools of pharmacy.
10. By rule, approve programs of practical experience, clinical programs, internship training programs, programs of remedial academic work and preliminary equivalency examinations as provided by this chapter.
11. Assist in the continuing education of pharmacists and pharmacy interns.
12. Issue inactive status licenses as provided by this chapter.
13. Accept monies and services from the federal government or others for educational, research or other purposes pertaining to the enforcement of this chapter.
14. By rule, except from the application of all or any part of this chapter any material, compound, mixture or preparation containing any stimulant or depressant substance included in section 13‑3401, paragraph 6, subdivision (c) or (d) from the definition of dangerous drug if the material, compound, mixture or preparation contains one or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system, provided that such admixtures are included in such combinations, quantity, proportion or concentration as to vitiate the potential for abuse of the substances that do have a stimulant or depressant effect on the central nervous system.
15. Adopt rules for the revocation, suspension or reinstatement of licenses or permits or the probation of licensees or permittees as provided by this chapter.
16. Issue a certificate of free sale to any person that is licensed by the board as a manufacturer for the purpose of manufacturing or distributing food supplements or dietary supplements as defined in rule by the board and that wants to sell food supplements or dietary supplements domestically or internationally. The application shall contain all of the following:
(a) The applicant's name, address, e-mail address, telephone and fax number.
(b) The product's full, common or usual name.
(c) A copy of the label for each product listed. If the product is to be exported in bulk and a label is not available, the applicant shall include a certificate of composition.
(d) The country of export, if applicable.
(e) The number of certificates of free sale requested.
17. Establish an inspection process for the issuance of to issue certificates of free sale or good manufacturing practice certifications. The board shall establish in rule:
(a) A fee for the issuance of to issue certificates of free sale.
(b) A fee for the issuance of to issue good manufacturing practice certifications.
(c) An annual inspection fee.
18. Delegate to the executive director the authority to:
(a) void a license or permit application and deem all fees forfeited by the applicant if the applicant provided inaccurate information on the application. Except for inaccurate information provided regarding education or criminal history, the applicant shall have the opportunity to correct the inaccurate information within thirty days after the initial application was voided. If the applicant provides inaccurate information regarding education or criminal history and the application is voided, the applicant may submit a new application with all associated fees.
(b) If the president or vice president of the board concurs after reviewing the case, enter into an interim consent agreement with a licensee or permittee if there is evidence that a restriction against the license or permit is needed to mitigate danger to the public health and safety. The board shall subsequently formally adopt the interim consent agreement with any modifications the board deems necessary for the agreement to be fully enforceable.
(c) Take no action or dismiss a complaint that has insufficient evidence that a violation of statute or rule occurred.
(d) Request an applicant or licensee to provide court documents and police reports if the applicant or licensee has been charged with or convicted of a criminal offense. The executive director may do either of the following if the applicant or licensee Fails to provide the requested documents to the board within fourteen business days after the request:
(i) Close the application, deem the application fee forfeited and not consider a new application complete unless the requested documents are submitted with the application.
(ii) Suspend the licensee and open a complaint for unprofessional conduct.
C. At each regularly scheduled board meeting the executive director shall provide to the board a list of the executive director's actions taken pursuant to subsection B, paragraph 18, subdivisions (a), (c) and (d) of this section since the last board meeting.
C. D. The executive director and other personnel or agents of the board are not subject to civil liability for any act done or proceeding undertaken or performed in good faith and in furtherance of the purposes of this chapter.
Sec. 2. Title 32, chapter 18, article 2, Arizona Revised Statutes, is amended by adding section 32-1921.01, to read:
32-1921.01. Disclosures on applications; licensees; applicability
A. A pharmacist, pharmacy intern, pharmacy technician and pharmacy technician trainee are not required to disclose the following information when filing an application under this chapter:
1. A single misdemeanor charge that was dismissed, expunged or set aside more than five years before the date of application.
2. A single misdemeanor conviction that occurred more than ten years before the date of application.
3. A single felony conviction that was reduced to a misdemeanor conviction or that was dismissed, expunged or set aside more than ten years before the date of application.
B. An applicant or licensee who has had more than one of any charge or conviction specified in subsection A of this section shall disclose that information to the board.
C. Subsection A of this section applies to current licensees.
Sec. 3. Section 32-1940, Arizona Revised Statutes, is amended to read:
32-1940. Investigations; hearings; conferences; records; confidentiality
A. Information received and records kept by the board in connection with investigations conducted pursuant to this chapter before a public hearing or conference are confidential and are not open to the public or subject to civil discovery.
B. Notwithstanding any other law or code of ethics regarding practitioner confidences, the physician‑patient privilege between a medical practitioner and a patient, both as it relates to the competency of the witness and to the exclusion of confidential communications, does not pertain to any board investigations or other proceedings conducted pursuant to this chapter to the extent necessary to determine if whether a violation of this chapter has occurred. Communications or records disclosed pursuant to this subsection are confidential and may be used only in a judicial or administrative proceeding or investigation resulting from a report, investigation or hearing required or authorized under this chapter.
C. The board, its employees and agents and any other person receiving this information shall keep the identity of the patient confidential at all times.
D. The board shall report evidence of a crime uncovered during an investigation to the appropriate criminal justice agency.
E. This section does not prevent the board from disclosing investigative materials concerning a licensee's alleged violation of this chapter to the licensee, or the licensee's attorney, another state or federal regulatory agency or a law enforcement agency.
Sec. 4. Section 32-1961, Arizona Revised Statutes, is amended to read:
32-1961. Limit on dispensing, compounding and sale of drugs
A. Except as otherwise provided in this chapter, it is unlawful for any person to compound, sell or dispense any drugs or to dispense or compound the prescription orders of a medical practitioner, unless that person is a pharmacist or a pharmacy intern acting under the direct supervision of a pharmacist. This subsection does not prevent a pharmacy technician or support personnel from assisting in the dispensing of drugs if this is done pursuant to rules adopted by the board and under the direct supervision of a licensed pharmacist or under remote supervision by a pharmacist.
B. Except as otherwise provided in this chapter, it is unlawful for any person, without placing a pharmacist in active personal charge at each place of business, to:
1. Open, advertise or conduct a pharmacy.
2. Stock, expose or offer drugs for sale at retail, except as otherwise specifically provided.
3. Use or exhibit the title "drug", "drugs", "drugstore", "drug shop", "pharmacy", "apothecary" or "prescription" or any combination of these words or titles or any title, symbol or description of like import or any other term designed to take its place.
Sec. 5. Section 32-1968, Arizona Revised Statutes, is amended to read:
32-1968. Dispensing prescription‑only drug; prescription orders; refills; labels; misbranding; dispensing soft contact lenses; opioid antagonists
A. A prescription‑only drug shall be dispensed only under one of the following conditions:
1. By a medical practitioner in conformance with section 32‑1921.
2. On a written prescription order bearing the prescribing medical practitioner's manual signature.
3. On an electronically transmitted prescription order containing the prescribing medical practitioner's electronic or digital signature that is reduced promptly to writing and filed by the pharmacist.
4. On a written prescription order generated from electronic media containing the prescribing medical practitioner's electronic or manual signature. A prescription order that contains only an electronic signature must be applied to paper that uses security features that will ensure the prescription order is not subject to any form of copying or alteration.
5. On an oral prescription order that is reduced promptly to writing and filed by the pharmacist.
6. By refilling any written, electronically transmitted or oral prescription order if a refill is authorized by the prescriber either in the original prescription order, by an electronically transmitted refill order that is documented promptly and filed by the pharmacist or by an oral refill order that is documented promptly and filed by the pharmacist.
7. On a prescription order that the prescribing medical practitioner or the prescribing medical practitioner's agent transmits by fax or e‑mail.
8. On a prescription order that the patient transmits by fax or by e‑mail if the patient presents a written prescription order bearing the prescribing medical practitioner's manual signature when the prescription‑only drug is picked up at the pharmacy.
B. A prescription order shall not be refilled if it is either:
1. Ordered by the prescriber not to be refilled.
2. More than one year since it was originally ordered.
C. A prescription order shall contain the date it was issued, the name and address of the person for whom or owner of the animal for which the drug is ordered, refills authorized, if any, the legibly printed name, address and telephone number of the prescribing medical practitioner, the name, strength, dosage form and quantity of the drug ordered and directions for its use.
D. Any drug dispensed in accordance with subsection A of this section is exempt from the requirements of section 32‑1967, except section 32‑1967, subsection A, paragraphs 1, 10 and 11 and the packaging requirements of section 32‑1967, subsection A, paragraphs 7 and 8, if the drug container bears a label containing the name and address of the dispenser, 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, directions for use and cautionary statements, if any, contained in the order. This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or the internet or to a drug dispensed in violation of subsection A of this section.
E. The board by rule also may require additional information on the label of prescription medication that the board believes to be necessary for the best interest of the public's health and welfare.
F. A prescription‑only drug or a controlled substance that requires a prescription order is deemed to be misbranded if, at any time before dispensing, its label fails to bear the statement "Rx only". A drug to which subsection A of this section does not apply is deemed to be misbranded if, at any time before dispensing, its label bears the caution statement quoted in this subsection.
G. A pharmacist may fill a prescription order for soft contact lenses only as provided in this chapter.
H. A pharmacist may dispense naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration on the receipt of a standing order and according to protocols adopted by the board pursuant to section 32‑1979. For the purposes of this subsection, "standing order" means a signed prescription order that authorizes the pharmacist to dispense naloxone hydrochloride or any other opioid antagonist for emergency purposes and that is issued by a medical practitioner licensed in this state or a state or county health officer who is a medical practitioner licensed in this state.
Sec. 6. Repeal
Section 32-1971, Arizona Revised Statutes, is repealed.
Sec. 7. Section 32-1977, Arizona Revised Statutes, is amended to read:
32-1977. Sale of methamphetamine precursors by a pharmacy permittee; electronic sales tracking system; violation; classification; state preemption
A. A retailer permittee under this chapter shall not sell to the same person, and a person shall not purchase, products containing more than three and six-tenths grams per day or more than nine grams per thirty‑day period of ephedrine or pseudoephedrine base, or their salts, isomers or salts of isomers. These limits apply to the total amount of base ephedrine and pseudoephedrine contained in the products and not to the overall weight of the products.
B. The retailer permittee must keep nonprescription products containing pseudoephedrine or ephedrine behind the counter or in a locked case where a customer does not have direct access.
C. The retailer permittee shall require a person purchasing a nonprescription product that contains pseudoephedrine or ephedrine to present valid government issued government-issued photo identification at the point of sale. The retailer permittee shall record all of the following:
1. The name and address of the purchaser.
2. The name and quantity of product purchased.
3. The date and time of purchase.
4. Purchaser identification type and number.
D. Beginning January 1, 2013, Before completing a sale pursuant to this section, a retailer permittee must use an electronic sales tracking system and electronically submit the required information to the national precursor log exchange administered by the national association of drug diversion investigators if the system is available to retailers permittees without a charge for access. For the purposes of this subsection, "available to retailers permittees without a charge for access":
1. Includes:
(a) Access to the web-based electronic sales tracking software, including inputting and retrieving data free of charge.
(b) Training free of charge.
(c) Technical support to integrate to point of sale vendors without a charge, if necessary.
2. Does not include:
(a) Costs relating to required internet access.
(b) Optional hardware that a pharmacy may choose to purchase for workflow purposes.
(c) Other equipment.
E. If a retailer permittee that sells a nonprescription product containing pseudoephedrine or ephedrine experiences mechanical or electronic failure of the electronic sales tracking system and is unable to comply with the electronic sales tracking requirements of this section, the retailer permittee must maintain a written log or an alternative electronic recordkeeping mechanism until the retailer permittee is able to comply with the electronic sales tracking system requirements. A retailer permittee that does not have internet access to the electronic sales tracking system is compliant with the requirements of this section if the retailer maintains a written log or an alternative electronic recordkeeping mechanism.
F. The national association of drug diversion investigators shall forward state transaction records in the national precursor log exchange to the board of pharmacy each week and provide real-time access to the national precursor log exchange information through the national precursor log exchange online portal to law enforcement in this state as authorized by the board of pharmacy.
G. The system prescribed in this section must be capable of generating a stop sale alert notification that completion of completing the sale would result in the retailer permittee or purchaser violating the quantity limits prescribed in this section. The retailer permittee may not complete the sale if the system generates a stop sale alert. The electronic sales tracking system prescribed in this section must contain an override function that may be used by dispensers of ephedrine or pseudoephedrine who have a reasonable fear of imminent bodily harm if they do not complete a sale. The system must log each instance that a retailer permittee uses the override function.
H. A person who violates this section is guilty of a class 3 misdemeanor, punishable by fine only.
I. This section does not apply to a person who obtains the product pursuant to a valid prescription order.
J. The reporting of sales of ephedrine or pseudoephedrine products is of statewide concern. The regulation of sales pursuant to this section is not subject to further regulation by a county, city, town or other political subdivision of this state.
Sec. 8. Section 32-3248.02, Arizona Revised Statutes, is amended to read:
32-3248.02. Health professionals; substance use or addiction continuing education
A health professional who is authorized under this title to prescribe schedule II controlled substances and who has a valid United States drug enforcement administration registration number or who is authorized under chapter 18 of this title to dispense controlled substances shall complete a minimum of three hours of opioid‑related, substance use disorder‑related or addiction‑related continuing medical education each license renewal cycle. The three hours of continuing medical education or accredited continuing education that is approved by the applicable health profession regulatory board shall be included as part of any continuing education requirements for that health professional.
Sec. 9. Section 36-2525, Arizona Revised Statutes, is amended to read:
36-2525. 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, except for any of the following:
1. The date issued.
2. The strength, dosage form or quantity of drug.
3. The directions for its use.
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 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, 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 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. 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 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 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, 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.
APPROVED BY THE GOVERNOR MAY 25, 2019.
FILED IN THE OFFICE OF THE SECRETARY OF STATE MAY 25, 2019.
