Bill Text: AZ SB1372 | 2020 | Fifty-fourth Legislature 2nd Regular | Introduced
Bill Title: Pharmacy board; regulation; nondisciplinary action
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2020-01-30 - Senate read second time [SB1372 Detail]
Download: Arizona-2020-SB1372-Introduced.html
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REFERENCE TITLE: pharmacy board; regulation; nondisciplinary action |
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State of Arizona Senate Fifty-fourth Legislature Second Regular Session 2020
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SB 1372 |
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Introduced by Senator Pace
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AN ACT
Amending sections 32‑1901 and 32‑1901.01, Arizona Revised Statutes; amending section 32‑1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 257, section 1; repealing section 32‑1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 320, section 1; amending sections 32‑1907, 32‑1922, 32‑1924, 32‑1925, 32‑1927, 32‑1927.01, 32‑1927.02, 32‑1927.03, 32‑1930, 32‑1931, 32‑1937, 32‑1965, 32‑1967, 32‑1982, 36‑2602, 36‑2607 and 36‑2608, 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 32-1901, Arizona Revised Statutes, is amended to read:
32-1901. Definitions
In this chapter, unless the context otherwise requires:
1. "Administer" means the direct application of directly applying a controlled substance, prescription‑only drug, dangerous drug or narcotic drug, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by a practitioner or by the practitioner's authorized agent or the patient or research subject at the direction of the practitioner.
2. "Advertisement" means all representations that are disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of drugs, devices, poisons or hazardous substances.
3. "Advisory letter" means a nondisciplinary letter to notify a licensee or permittee that either:
(a) While there is insufficient evidence to support disciplinary action, the board believes that continuation of the activities that led to the investigation may result in further board action against the licensee or permittee.
(b) The violation is a minor or technical violation that is not of sufficient merit to warrant disciplinary action.
(c) While the licensee or permittee has demonstrated substantial compliance through rehabilitation, remediation or reeducation that has mitigated the need for disciplinary action, the board believes that repetition of repeating the activities that led to the investigation may result in further board action against the licensee or permittee.
4. "Antiseptic", if a drug is represented as such on its label, means a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment or dusting powder or other use that involves prolonged contact with the body.
5. "Authorized officers of the law" means legally empowered peace officers, compliance officers of the board of pharmacy and agents of the division of narcotics enforcement and criminal intelligence of the department of public safety.
6. "Automated prescription‑dispensing kiosk" means a mechanical system that is operated as an extension of a pharmacy, that maintains all transaction information within the pharmacy operating system, that is separately permitted from the pharmacy and that performs operations that either:
(a) Accept a prescription or refill order, store prepackaged or repackaged medications, label and dispense patient‑specific prescriptions and provide counseling on new or refilled prescriptions.
(b) Dispense or deliver a prescription or refill that has been prepared by or on behalf of the pharmacy that oversees the automated prescription‑dispensing kiosk.
7. "Board" or "board of pharmacy" means the Arizona state board of pharmacy.
8. "Certificate of composition" means a list of a product's ingredients.
9. "Certificate of free sale" means a document that authenticates a product that is generally and freely sold in domestic or international channels of trade.
10. "Color additive" means a material that either:
(a) Is any dye, pigment or other substance that is made by a process of synthesis or similar artifice, or that is extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from any vegetable, animal, mineral or other source.
(b) If added or applied to a drug, or to the human body or any part of the human body, is capable of imparting color, except that color additive does not include any material that has been or may be exempted under the federal act. Color includes black, white and intermediate grays.
11. "Compounding" means the preparation preparing, mixing, assembling, packaging or labeling of a drug by a pharmacist or an intern or pharmacy technician under the pharmacist's supervision, for the purpose of dispensing to a patient based on a valid prescription order. Compounding includes the preparation of preparing drugs in anticipation of prescription orders prepared on routine, regularly observed prescribing patterns and the preparation of preparing drugs as an incident to research, teaching or chemical analysis or for administration by a medical practitioner to the medical practitioner's patient and not for sale or dispensing. Compounding does not include the preparation of preparing commercially available products from bulk compounds or the preparation of preparing drugs for sale to pharmacies, practitioners or entities for the purpose of dispensing or distribution.
12. "Compressed medical gas distributor" means a person who that holds a current permit issued by the board to distribute compressed medical gases pursuant to a compressed medical gas order to compressed medical gas suppliers and other entities that are registered, licensed or permitted to use, administer or distribute compressed medical gases.
13. "Compressed medical gases" means gases and liquid oxygen that a compressed medical gas distributor or manufacturer has labeled in compliance with federal law.
14. "Compressed medical gas order" means an order for compressed medical gases that is issued by a medical practitioner.
15. "Compressed medical gas supplier" means a person who that holds a current permit issued by the board to supply compressed medical gases pursuant to a compressed medical gas order and only to the consumer or the patient.
16. "Controlled substance" means a drug, substance or immediate precursor that is identified, defined or listed in title 36, chapter 27, article 2.
17. "Corrosive" means any substance that when it comes in contact with living tissue will cause destruction of the tissue by chemical action.
18. "Counterfeit drug" means a drug that, or the container or labeling of which, without authorization, bears the trademark, trade name or other identifying mark, imprint, number or device, or any likeness of these, of a manufacturer, distributor or dispenser other than the person who that in fact manufactured, distributed or dispensed that drug.
19. "Dangerous drug" has the same meaning prescribed in section 13‑3401.
20. "Day" means a business day.
21. "Decree of censure" means an official action that is taken by the board and that may include a requirement for restitution of fees to a patient or consumer.
22. "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another whether or not there is an agency relationship.
23. "Deputy director" means a pharmacist who is employed by the board and selected by the executive director to perform duties as prescribed by the executive director.
24. "Device", except as used in paragraph 18 of this section, section 32‑1965, paragraph 4 and section 32‑1967, subsection A, paragraph 15 and subsection C, means instruments an instrument, apparatuses and contrivances apparatus and contrivance, including their its components, parts and accessories, including all such items under the federal act, that is intended either:
(a) For use in the diagnosis, cure, mitigation, treatment or prevention of diagnosing, curing, mitigating, treating or preventing disease in the human body or other animals.
(b) To affect the structure or any function of the human body or other animals.
25. "Director" means the director of the division of narcotics enforcement and criminal investigation of the department of public safety.
26. "Direct supervision of a pharmacist" means that the pharmacist is present. If relating to the sale of certain items, direct supervision of a pharmacist means that a pharmacist determines the legitimacy or advisability of a proposed purchase of those items.
27. "Dispense" means to deliver to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling or compounding necessary to prepare for that delivery.
28. "Dispenser" means a practitioner who dispenses.
29. "Distribute" means to deliver, other than by administering or dispensing.
30. "Distributor" means a person who distributes.
31. "Drug" means:
(a) Articles that are recognized, or for which standards or specifications are prescribed, in the official compendium.
(b) Articles that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in the human body or other animals.
(c) Articles other than food that are intended to affect the structure or any function of the human body or other animals.
(d) Articles that are intended for use as a component of any articles specified in subdivision (a), (b) or (c) of this paragraph but does not include devices or their components, parts or accessories.
32. "Drug enforcement administration" means the drug enforcement administration of the United States department of justice or its successor agency.
33. "Drug or device manufacturing" means the production, preparation, propagation producing, preparing, propagating or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis and includes any packaging or repackaging of substances or labeling or relabeling of its container and the promotion promoting and marketing of the same. Drug or device manufacturing does not include compounding.
34. "Durable medical equipment" means technologically sophisticated medical equipment as prescribed by the board in rule that a patient or consumer may use in a home or residence and that may be a prescription‑only device.
35. "Durable medical equipment distributor":
(a) Means a person that stores or distributes durable medical equipment other than to the ultimate user.
(b) Includes a virtual durable medical equipment distributor as prescribed in rule by the board.
36. "Durable medical equipment supplier":
(a) Means a person that sells, leases or rents durable medical equipment to the ultimate user.
(b) Includes a virtual durable medical equipment supplier as prescribed in rule by the board.
34. 37. "Economic poison" means any substance that alone, in chemical combination with or in formulation with one or more other substances is a pesticide within the meaning of the laws of this state or the federal insecticide, fungicide and rodenticide act and that is used in the production, storage producing, storing or transportation of transporting raw agricultural commodities.
35. 38. "Enteral feeding" means nourishment that is provided by means of a tube inserted into the stomach or intestine.
36. 39. "Established name", with respect to a drug or ingredient of a drug, means any of the following:
(a) The applicable official name.
(b) If there is no such name and the drug or ingredient is an article recognized in an official compendium, the official title in an official compendium.
(c) If neither subdivision (a) nor (b) of this paragraph applies, the common or usual name of the drug.
37. 40. "Executive director" means the executive director of the board of pharmacy.
38. 41. "Federal act" means the federal laws and regulations that pertain to drugs, devices, poisons and hazardous substances and that are official at the time any drug, device, poison or hazardous substance is affected by this chapter.
39. 42. "Full service Full‑service wholesale permittee":
(a) Means a permittee who may distribute prescription‑only drugs and devices, controlled substances and over‑the‑counter drugs and devices to pharmacies or other legal outlets from a place devoted in whole or in part to wholesaling these items.
(b) Includes a virtual wholesaler as defined in rule by the board.
40. 43. "Good manufacturing practice" means a system for ensuring that products are consistently produced and controlled according to quality standards and covering all aspects of design, monitoring and control of manufacturing processes and facilities to ensure that products do not pose any risk to the consumer or public.
41. 44. "Highly toxic" means any substance that falls within any of the following categories:
(a) Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered.
(b) Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, if inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided the concentration is likely to be encountered by humans if the substance is used in any reasonably foreseeable manner.
(c) Produces death within fourteen days in half or more than half of a group of ten or more rabbits tested in a dosage of two hundred milligrams or less per kilogram of body weight, if administered by continuous contact with the bare skin for twenty‑four hours or less.
If the board finds that available data on human experience with any substance indicate results different from those obtained on animals in the dosages or concentrations prescribed in this paragraph, the human data shall take precedence.
42. 45. "Hospital" means any institution for the care and treatment of the sick and injured that is approved and licensed as a hospital by the department of health services.
43. 46. "Intern" means a pharmacy intern.
44. 47. "Internship" means the practical, experiential, hands‑on training of a pharmacy intern under the supervision of a preceptor.
45. 48. "Irritant" means any substance, other than a corrosive, that on immediate, prolonged or repeated contact with normal living tissue will induce a local inflammatory reaction.
46. 49. "Jurisprudence examination" means a board‑approved pharmacy law examination that is written and administered in cooperation with the national association of boards of pharmacy or another board‑approved pharmacy law examination.
47. 50. "Label" means a display of written, printed or graphic matter on the immediate container of any article that, unless easily legible through the outside wrapper or container, also appears on the outside wrapper or container of the article's retail package. For the purposes of this paragraph, the immediate container does not include package liners.
48. 51. "Labeling" means all labels and other written, printed or graphic matter that either:
(a) Is on any article or any of its containers or wrappers.
(b) Accompanying Accompanies that article.
49. 52. "Letter of reprimand" means a disciplinary letter that is a public document issued by the board and that informs a licensee or permittee that the licensee's or permittee's conduct violates state or federal law and may require the board to monitor the licensee or permittee.
50. 53. "Limited service pharmacy" means a pharmacy that is approved by the board to practice a limited segment of pharmacy as indicated by the permit issued by the board.
51. 54. "Manufacture" or "manufacturer":
(a) Means every person who prepares, derives, produces, compounds, processes, packages or repackages or labels any drug in a place, other than a pharmacy, that is devoted to manufacturing the drug.
(b) Includes a virtual manufacturer as defined in rule by the board.
52. 55. "Marijuana" has the same meaning prescribed in section 13‑3401.
53. 56. "Medical practitioner" means any medical doctor, doctor of osteopathic medicine, dentist, podiatrist, veterinarian or other person who is licensed and authorized by law to use and prescribe drugs and devices for the treatment of to treat sick and injured human beings or animals or for the diagnosis to diagnose or prevention of prevent sickness in human beings or animals in this state or any state, territory or district of the United States.
54. 57. "Medication order" means a written or verbal order from a medical practitioner or that person's authorized agent to administer a drug or device.
55. 58. "Narcotic drug" has the same meaning prescribed in section 13‑3401.
56. 59. "New drug" means either:
(a) Any drug of which the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling.
(b) Any drug of which the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but that has not, other than in the investigations, been used to a material extent or for a material time under those conditions.
57. 60. "Nonprescription drug" or "over‑the‑counter drug" means any nonnarcotic medicine or drug that may be sold without a prescription and that is prepackaged and labeled for use by the consumer in accordance with the requirements of the laws of this state and federal law. Nonprescription drug does not include:
(a) A drug that is primarily advertised and promoted professionally to medical practitioners and pharmacists by manufacturers or primary distributors.
(b) A controlled substance.
(c) A drug that is required to bear a label that states "Rx only".
(d) A drug that is intended for human use by hypodermic injection.
58. 61. "Nonprescription drug wholesale permittee":
(a) Means a permittee who may distribute only over‑the‑counter drugs and devices to pharmacies or other lawful outlets from a place devoted in whole or in part to wholesaling these items.
(b) Includes a virtual wholesaler as defined in rule by the board.
59. 62. "Notice" means personal service or the mailing of a copy of the notice by certified mail addressed either to the person at the person's latest address of record in the board office or mail or email and to the person's attorney using the most recent information provided to the board in the board's licensing database.
60. 63. "Nutritional supplementation" means vitamins, minerals and caloric supplementation. Nutritional supplementation does not include medication or drugs.
61. 64. "Official compendium" means the latest revision of the United States pharmacopeia and the national formulary or any current supplement.
62. 65. "Other jurisdiction" means one of the other forty‑nine states, the District of Columbia, the Commonwealth of Puerto Rico or a territory of the United States of America.
63. 66. "Package" means a receptacle that is defined or described in the United States pharmacopeia and the national formulary as adopted by the board.
64. 67. "Packaging" means the act or process of placing a drug item or device in a container for the purpose or intent of dispensing or distributing the item or device to another.
65. 68. "Parenteral nutrition" means intravenous feeding that provides a person an individual with fluids and essential nutrients the person individual needs while the person individual is unable to receive adequate fluids or feedings by mouth or by enteral feeding.
66. 69. "Person" means an individual, partnership, corporation and association, and their duly authorized agents.
67. 70. "Pharmaceutical care" means the provision of drug therapy and other pharmaceutical patient care services.
68. 71. "Pharmacist" means an individual who is currently licensed by the board to practice the profession of pharmacy in this state.
69. 72. "Pharmacist in charge" means the pharmacist who is responsible to the board for a licensed establishment's compliance with the laws and administrative rules of this state and of the federal government pertaining to the practice of pharmacy, the manufacturing of drugs and the distribution of drugs and devices.
70. 73. "Pharmacist licensure examination" means a board‑approved examination that is written and administered in cooperation with the national association of boards of pharmacy or any other board‑approved pharmacist licensure examination.
71. 74. "Pharmacy":
(a) Means:
(i) Any place where drugs, devices, poisons or related hazardous substances are offered for sale at retail.
(ii) Any place in which the profession of pharmacy is practiced or where prescription orders are compounded and dispensed.
(iii) Any place that has displayed on it or in it the words "pharmacist", "pharmaceutical chemist", "apothecary", "druggist", "pharmacy", "drugstore", "drugs" or "drug sundries" or any of these words or combinations of these words, or words of similar import either in English or any other language, or that is advertised by any sign containing any of these words.
(iv) Any place where the characteristic symbols of pharmacy or the characteristic prescription sign "Rx" is exhibited.
(v) Any place or a portion of any building or structure that is leased, used or controlled by the permittee to conduct the business authorized by the board at the address for which the permit was issued and that is enclosed and secured when a pharmacist is not in attendance.
(vi) A remote dispensing site pharmacy where a pharmacy technician or pharmacy intern prepares, compounds or dispenses prescription medications under remote supervision by a pharmacist.
(vii) A remote hospital site pharmacy, as defined by the board in rule, that operates under direct or remote supervision by a pharmacist and pursuant to rules adopted by the board.
(b) Includes a satellite pharmacy.
72. 75. "Pharmacy intern" means a person who has all of the qualifications and experience prescribed in section 32‑1923.
73. 76. "Pharmacy technician" means a person who is licensed pursuant to this chapter.
74. 77. "Pharmacy technician trainee" means a person who is licensed pursuant to this chapter.
75. 78. "Poison" or "hazardous substance" includes, but is not limited to, any of the following if intended and suitable for household use or use by children:
(a) Any substance that, according to standard works on medicine, pharmacology, pharmacognosy or toxicology, if applied to, introduced into or developed within the body in relatively small quantities by its inherent action uniformly produces serious bodily injury, disease or death.
(b) A toxic substance.
(c) A highly toxic substance.
(d) A corrosive substance.
(e) An irritant.
(f) A strong sensitizer.
(g) A mixture of any of the substances described in this paragraph, if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.
(h) A substance that is designated by the board to be a poison or hazardous substance. This subdivision does not apply to radioactive substances, economic poisons subject to the federal insecticide, fungicide and rodenticide act or the state pesticide act, foods, drugs and cosmetics subject to state laws or the federal act or substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house. This subdivision applies to any substance or article that is not itself an economic poison within the meaning of the federal insecticide, fungicide and rodenticide act or the state pesticide act, but that is a poison or hazardous substance within the meaning of this paragraph by reason of bearing or containing an economic poison or hazardous substance.
76. 79. "Practice of pharmacy":
(a) Means furnishing the following health care services as a medical professional:
(i) Interpreting, evaluating and dispensing prescription orders in the patient's best interests.
(ii) Compounding drugs pursuant to or in anticipation of a prescription order.
(iii) Labeling drugs and devices in compliance with state and federal requirements.
(iv) Participating in drug selection and drug utilization reviews, drug administration, drug or drug-related research and drug therapy monitoring or management.
(v) Providing patient counseling necessary to provide pharmaceutical care.
(vi) Properly and safely storing drugs and devices in anticipation of dispensing.
(vii) Maintaining required records of drugs and devices.
(viii) Offering or performing acts, services, operations or transactions that are necessary in the conduct, operation, management conducting, operating, managing and control of controlling a pharmacy.
(ix) Initiating, monitoring and modifying drug therapy pursuant to a protocol‑based drug therapy agreement with a provider as outlined in section 32‑1970.
(x) Initiating and administering immunizations or vaccines pursuant to section 32‑1974.
(b) Does not include initiating a prescription order for any medication, drug or other substance used to induce or cause a medication abortion as defined in section 36‑2151.
77. 80. "Practitioner" means any physician, dentist, veterinarian, scientific investigator or other person who is licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or administer a controlled substance in the course of professional practice or research in this state, or any pharmacy, hospital or other institution that is licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or administer a controlled substance in the course of professional practice or research in this state.
78. 81. "Preceptor" means a pharmacist who is serving as the practical instructor of an intern and who complies with section 32‑1923.
79. 82. "Precursor chemical" means a substance that is:
(a) The principal compound that is commonly used or that is produced primarily for use and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.
(b) Listed in section 13‑3401, paragraph 26 or 27.
80. 83. "Prescription" means either a prescription order or a prescription medication.
81. 84. "Prescription medication" means any drug, including label and container according to context, that is dispensed pursuant to a prescription order.
82. 85. "Prescription‑only device" includes:
(a) Any device that is limited by the federal act to use under the supervision of a medical practitioner.
(b) Any device required by the federal act to bear on its label essentially the legend "Rx only".
83. 86. "Prescription‑only drug" does not include a controlled substance but does include:
(a) Any drug that because of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use is not generally recognized among experts, qualified by scientific training and experience to evaluate its safety and efficacy, as safe for use except by or under the supervision of a medical practitioner.
(b) Any drug that is limited by an approved new drug application under the federal act or section 32‑1962 to use under the supervision of a medical practitioner.
(c) Every potentially harmful drug, the labeling of which does not bear or contain full and adequate directions for use by the consumer.
(d) Any drug, other than a controlled substance, that is required by the federal act to bear on its label the legend "Rx only".
84. 87. "Prescription order" means any of the following:
(a) An order to a pharmacist for drugs or devices that is issued and signed by a duly licensed medical practitioner in the authorized course of the practitioner's professional practice.
(b) An order that is transmitted to a pharmacist through word of mouth, telephone or other means of communication directed by that medical practitioner. Prescription orders received by word of mouth, telephone or other means of communication shall be maintained by the pharmacist pursuant to section 32‑1964, and the record so made by the pharmacist constitutes the original prescription order to be dispensed by the pharmacist. This paragraph does not alter or affect laws of this state or any federal act requiring a written prescription order.
(c) An order that is initiated by a pharmacist pursuant to a protocol-based drug therapy agreement with a provider as outlined in section 32‑1970, or immunizations or vaccines administered by a pharmacist pursuant to section 32‑1974.
(d) A diet order or an order for enteral feeding, nutritional supplementation or parenteral nutrition that is initiated by a registered dietitian or other qualified nutrition professional in a hospital pursuant to section 36‑416.
85. 88. "Professionally incompetent" means:
(a) Incompetence based on a variety of factors, including a lack of sufficient pharmaceutical knowledge or skills or experience to a degree likely to endanger the health of patients.
(b) When considered with other indications of professional incompetence, a pharmacist or pharmacy intern who fails to obtain a passing score on a board‑approved pharmacist licensure examination or a pharmacy technician or pharmacy technician trainee who fails to obtain a passing score on a board‑approved pharmacy technician licensure examination.
86. 89. "Radioactive substance" means a substance that emits ionizing radiation.
87. 90. "Remote dispensing site pharmacy" means a pharmacy where a pharmacy technician or pharmacy intern prepares, compounds or dispenses prescription medications under remote supervision by a pharmacist.
88. 91. "Remote supervision by a pharmacist" means that a pharmacist directs and controls the actions of pharmacy technicians and pharmacy interns through the use of audio and visual technology.
89. 92. "Revocation" or "revoke" means the official cancellation of a license, permit, registration or other approval authorized by the board for a period of two years unless otherwise specified by the board. A request or new application for reinstatement may be presented to the board for review before the conclusion of the specified revocation period upon review of the executive director.
90. 93. "Safely engage in employment duties" means that a permittee or the permittee's employee is able to safely engage in employment duties related to the manufacture, sale, distribution or dispensing of drugs, devices, poisons, hazardous substances, controlled substances or precursor chemicals.
91. 94. "Satellite pharmacy" means a work area located within a hospital or on a hospital campus that is not separated by other commercial property or residential property, that is under the direction of a pharmacist, that is a remote extension of a centrally licensed hospital pharmacy, and that is owned by and dependent on the centrally licensed hospital pharmacy for administrative control, staffing and drug procurement and that is not required to be separately permitted.
92. 95. "Symbol" means the characteristic symbols that have historically identified pharmacy, including show globes and mortar and pestle, and the sign "Rx".
93. 96. "Third‑party logistics provider" means an entity that provides or coordinates warehousing or other logistics services for a prescription or over‑the‑counter dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler or dispenser of the prescription or over‑the‑counter dangerous drug or dangerous device but that does not take ownership of the prescription or over‑the‑counter dangerous drug or dangerous device or have responsibility to direct its sale or disposition.
94. 97. "Toxic substance" means a substance, other than a radioactive substance, that has the capacity to produce injury or illness in humans through ingestion, inhalation or absorption through any body surface.
95. 98. "Ultimate user" means a person who lawfully possesses a drug or controlled substance for that person's own use, for the use of a member of that person's household or for administering to an animal owned by that person or by a member of that person's household.
Sec. 2. Section 32-1901.01, Arizona Revised Statutes, is amended to read:
32-1901.01. Definition of unethical and unprofessional conduct; permittees; licensees
A. In this chapter, unless the context otherwise requires, for the purposes of disciplining a permittee, "unethical conduct" means the following, whether occurring in this state or elsewhere:
1. Committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude or any drug-related offense. In either case, conviction by a court of competent jurisdiction or a plea of no contest is conclusive evidence of the commission.
2. Committing an act that is substantially related to the qualifications, functions or duties of a permittee and that demonstrates either a lack of good moral character or an actual or potential unfitness to hold a permit in light of the public's safety.
3. Working under the influence of alcohol or other drugs.
4. Being addicted to the use of alcohol or other drugs to such a degree as to render the permittee unfit to perform the permittee's employment duties.
5. Violating a federal or state law or administrative rule relating to the manufacture, sale or distribution of drugs, devices, poisons, hazardous substances or precursor chemicals.
6. Violating a federal or state law or administrative rule relating to marijuana, prescription‑only drugs, narcotics, dangerous drugs, controlled substances or precursor chemicals.
7. Violating state or federal reporting or recordkeeping requirements on transactions relating to precursor chemicals.
8. 5. Failing to report in writing to the board any evidence that a pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the practice of pharmacy.
9. 6. Failing to report in writing to the board any evidence that a pharmacy technician or pharmacy technician trainee is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the permissible activities of a pharmacy technician or pharmacy technician trainee.
10. 7. Failing to report in writing to the board any evidence that appears to show that a permittee or permittee's employee is or may be guilty of unethical conduct, is or may be mentally or physically unable safely to engage in employment duties related to manufacturing, selling, distributing or dispensing of drugs, devices, poisons, hazardous substances, controlled substances or precursor chemicals or is or may be in violation of violating this chapter or a rule adopted under this chapter.
11. 8. Intending to sell, transfer or distribute, or to offer for sale, transfer or distribution, or selling, transferring, distributing or dispensing or offering for sale, transfer or distribution an imitation controlled substance, imitation over‑the‑counter drug or imitation prescription‑only drug as defined in section 13‑3451.
12. 9. Having the permittee's permit to manufacture, sell, distribute or dispense drugs, devices, poisons, hazardous substances or precursor chemicals denied or disciplined in another jurisdiction.
13. 10. Committing an offense in another jurisdiction that if committed in this state would be grounds for discipline.
14. 11. Obtaining or attempting to obtain a permit or a permit renewal by fraud, by misrepresentation or by knowingly taking advantage of the mistake of another person or an agency.
15. 12. Wilfully making a false report or record that is required by this chapter, that is required by federal or state laws pertaining to drugs, devices, poisons, hazardous substances or precursor chemicals or that is required for the payment to pay for drugs, devices, poisons or hazardous substances or precursor chemicals or for services pertaining to such drugs or substances.
16. 13. Knowingly filing with the board any application, renewal or other document that contains false or misleading information.
17. 14. Providing false or misleading information or omitting material information in any communication to the board or the board's employees or agents.
18. 15. Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, a federal or state law or any rule adopted pursuant to this chapter.
19. 16. Violating a formal order, terms of probation, a consent agreement or a stipulation issued or entered into by the board or its executive director pursuant to this chapter.
20. 17. Failing to comply with a board subpoena or failing to comply in a timely manner with a board subpoena without providing any explanation to the board for not complying with the subpoena.
21. 18. Failing to provide the board or its employees or agents or an authorized federal or state official conducting a site investigation, inspection or audit with access to any place for which a permit has been issued or for which an application for a permit has been submitted.
22. 19. Failing to notify the board of a change of ownership, management or pharmacist in charge.
23. 20. Failing to promptly produce on the request of the official conducting a site investigation, inspection or audit any book, record or document.
24. 21. Overruling or attempting to overrule a pharmacist in matters of pharmacy ethics or interpreting laws pertaining to the practice of pharmacy or the distribution of drugs or devices.
25. 22. Distributing premiums or rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient.
26. 23. Failing to maintain effective controls against the diversion of controlled substances or precursor chemicals to unauthorized persons or entities.
27. 24. Fraudulently claiming to have performed a service.
28. 25. Fraudulently charging a fee for a service.
29. 26. Advertising drugs or devices, or services pertaining to drugs or devices, in a manner that is untrue or misleading in any particular, and that is known, or that by the exercise of reasonable care should be known, to be untrue or misleading.
B. In this chapter, unless the context otherwise requires, for the purposes of disciplining a pharmacist or pharmacy intern, "unprofessional conduct" means the following, whether occurring in this state or elsewhere:
1. Being addicted to the use of alcohol or other drugs to such a degree as to render the licensee unfit to practice the profession of pharmacy.
2. Violating any federal or state law, rule or regulation relating to the manufacture or distribution of drugs and devices or the practice of pharmacy.
3. 2. Dispensing a different drug or brand of drug in place of the drug or brand of drug ordered or prescribed without the express permission in each case of the orderer, or in the case of a prescription order, the medical practitioner. The conduct prohibited by this paragraph does not apply to substitutions authorized pursuant to section 32‑1963.01.
4. 3. Obtaining or attempting to obtain a license to practice pharmacy or a license renewal by fraud, by misrepresentation or by knowingly taking advantage of the mistake of another person or an agency.
5. 4. Having the licensee's license to practice pharmacy denied or disciplined in another this state, by a federal agency in this state or by any other jurisdiction.
6. 5. Claiming professional superiority in compounding or dispensing prescription orders.
7. 6. Failing to comply with the mandatory continuing professional pharmacy education requirements of sections 32‑1936 and 32‑1937 and rules adopted by the board.
8. 7. Committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude or any drug-related offense. In either case, conviction by a court of competent jurisdiction or a plea of no contest is conclusive evidence of the commission.
9. 8. Working under the influence of alcohol or other drugs.
10. Violating a federal or state law or administrative rule relating to marijuana, prescription‑only drugs, narcotics, dangerous drugs, controlled substances or precursor chemicals when determined by the board or by conviction in a federal or state court.
11. 9. Knowingly dispensing a drug without a valid prescription order as required pursuant to section 32‑1968, subsection A.
12. 10. Knowingly dispensing a drug on a prescription order that was issued in the course of the conduct of business of dispensing drugs pursuant to diagnosis by mail or the internet, unless the order was any of the following:
(a) Made by a physician who provides temporary patient supervision on behalf of the patient's regular treating licensed health care professional or provides a consultation requested by the patient's regular treating licensed health care professional.
(b) Made in an emergency medical situation as defined in section 41‑1831.
(c) Written to prepare a patient for a medical examination.
(d) Written or the prescription medications were issued for use by a county or tribal public health department for immunization programs or emergency treatment or in response to an infectious disease investigation, a public health emergency, an infectious disease outbreak or an act of bioterrorism. For the purposes of this subdivision, "bioterrorism" has the same meaning prescribed in section 36‑781.
(e) Written or antimicrobials were dispensed by the prescribing or dispensing physician to a contact as defined in section 36‑661 who is believed to have had significant exposure risk as defined in section 36‑661 with another person who has been diagnosed with a communicable disease as defined in section 36‑661.
(f) Written or the prescription medications were issued for administration of administering immunizations or vaccines listed in the United States centers for disease control and prevention's recommended immunization schedule to a household member of a patient.
(g) For epinephrine auto‑injectors that are written or dispensed for a school district or charter school and that are to be stocked for emergency use pursuant to section 15‑157 or for an authorized entity to be stocked pursuant to section 36‑2226.01.
(h) Written by a licensee through a telemedicine program that is covered by the policies and procedures adopted by the administrator of a hospital or outpatient treatment center.
(i) Written pursuant to a physical or mental health status examination that was conducted during a real‑time telemedicine encounter with audio and video capability.
(j) For naloxone hydrochloride or any other opioid antagonist approved by the United States food and drug administration and written or dispensed for use pursuant to section 36‑2228 or 36‑2266.
13. 11. Failing to report in writing to the board any evidence that a pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable to safely engage in the practice of pharmacy.
14. 12. Failing to report in writing to the board any evidence that a pharmacy technician or pharmacy technician trainee is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable to safely engage in the permissible activities of a pharmacy technician or pharmacy technician trainee.
15. 13. Failing to report in writing to the board any evidence that a permittee or a permittee's employee is or may be guilty of unethical conduct or is or may be in violation of violating this chapter or a rule adopted under this chapter.
16. 14. Committing an offense in another jurisdiction that if committed in this state would be grounds for discipline.
17. 15. Knowingly filing with the board any application, renewal or other document that contains false or misleading information.
18. 16. Providing false or misleading information or omitting material information in any communication to the board or the board's employees or agents.
19. 17. Violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, a federal or state law or any rule adopted pursuant to this chapter.
20. 18. Violating a formal order, terms of probation, a consent agreement or a stipulation issued or entered into by the board or its executive director pursuant to this chapter.
21. 19. Failing to comply with a board subpoena or failing to comply in a timely manner with a board subpoena without providing any explanation to the board for not complying with the subpoena.
22. 20. Refusing without just cause to allow authorized agents of the board to examine documents that are required to be kept pursuant to this chapter or title 36.
23. 21. Participating in an arrangement or agreement to allow a prescription order or a prescription medication to be left at, picked up from, accepted by or delivered to a place that is not licensed as a pharmacy. This paragraph does not prohibit a pharmacist or a pharmacy from using an employee or a common carrier to pick up prescription orders at or deliver prescription medications to the office or home of a medical practitioner, the residence of a patient or a patient's hospital.
24. 22. Paying rebates or entering into an agreement for the payment of paying rebates to a medical practitioner or any other person in the health care field.
25. 23. Providing or causing to be provided to a medical practitioner prescription order blanks or forms bearing the pharmacist's or pharmacy's name, address or other means of identification.
26. 24. Fraudulently claiming to have performed a professional service.
27. 25. Fraudulently charging a fee for a professional service.
28. 26. Failing to report a change of the licensee's home address, contact information, employer or employer's address as required by section 32‑1926.
29. 27. Failing to report a change in the licensee's residency status as required by section 32‑1926.01.
30. 28. Failing to maintain effective controls against the diversion of controlled substances or precursor chemicals to unauthorized persons or entities.
29. Violating a federal or state law or any rule adopted pursuant to this chapter.
C. In this chapter, unless the context otherwise requires, for the purposes of disciplining a pharmacy technician or pharmacy technician trainee, "unprofessional conduct" means the following, whether occurring in this state or elsewhere:
1. Being addicted to the use of alcohol or other drugs to such a degree as to render the licensee unfit to perform the licensee's employment duties.
2. Violating a federal or state law or administrative rule relating to the manufacture or distribution of drugs or devices.
3. 2. Obtaining or attempting to obtain a pharmacy technician or pharmacy technician trainee license or a pharmacy technician license renewal by fraud, by misrepresentation or by knowingly taking advantage of the mistake of another person or an agency.
4. 3. Having the licensee's license to practice as a pharmacy technician denied or disciplined in another this state, by a federal agency in this state or by any other jurisdiction.
5. 4. Failing to comply with the mandatory continuing professional education requirements of section 32‑1925, subsection H and rules adopted by the board.
6. 5. Committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude or any drug-related offense. In either case, conviction by a court of competent jurisdiction or a plea of no contest is conclusive evidence of the commission.
7. 6. Working under the influence of alcohol or other drugs.
8. Violating a federal or state law or administrative rule relating to marijuana, prescription‑only drugs, narcotics, dangerous drugs, controlled substances or precursor chemicals when determined by the board or by conviction in a federal or state court.
9. 7. Failing to report in writing to the board any evidence that a pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable to safely engage in the practice of pharmacy.
10. 8. Failing to report in writing to the board any evidence that a pharmacy technician or pharmacy technician trainee is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable to safely engage in the permissible activities of a pharmacy technician or pharmacy technician trainee.
11. 9. Failing to report in writing to the board any evidence that a permittee or a permittee's employee is or may be guilty of unethical conduct or is or may be in violation of violating this chapter or a rule adopted under this chapter.
12. 10. Committing an offense in another jurisdiction that if committed in this state would be grounds for discipline.
13. 11. Knowingly filing with the board any application, renewal or other document that contains false or misleading information.
14. 12. Providing false or misleading information or omitting material information in any communication to the board or the board's employees or agents.
15. 13. Violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, a federal or state law or any rule adopted pursuant to this chapter.
16. 14. Violating a formal order, terms of probation, a consent agreement or a stipulation issued or entered into by the board or its executive director pursuant to this chapter.
17. 15. Failing to comply with a board subpoena or failing to comply in a timely manner with a board subpoena without providing any explanation to the board for not complying with the subpoena.
18. 16. Failing to report a change of the licensee's home address, contact information, employer or employer's address as required by section 32‑1926.
19. 17. Failing to report a change in the licensee's residency status as required by section 32‑1926.01.
Sec. 3. Section 32-1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 257, section 1, is amended to read:
32-1904. Powers and duties of board; civil penalties; immunity
A. The board shall:
1. Make bylaws and adopt rules that are necessary 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 to register and 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, 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 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 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 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.
13. Open an investigation only if the identifying information regarding a complainant is provided or the information provided is sufficient to conduct an investigation.
14. Provide notice to an applicant, licensee or permittee using only the information provided to the board through the board's licensing database.
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 educating and informing the licensees and the public, assistance in 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 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 to issue certificates of free sale or good manufacturing practice certifications. The board shall establish in rule:
(a) A fee to issue certificates of free sale.
(b) A fee 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 reviewed by board staff and the applicant was informed of the inaccuracy.
(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 may 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 thirty 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.
(ii) Notify the licensee of an opportunity for a hearing in accordance with section 41‑1061 to consider suspension of the licensee.
(e) Pursuant to section 36‑2604, subsection B, review prescription information collected pursuant to title 36, chapter 28, article 1.
19. Charge an administrative fee as prescribed in rule by the board for complaint‑initiated nonroutine investigations conducted by the board. The fee collected for an investigation shall be calculated on an hourly rate multiplied by the amount of time needed to complete the investigation.
20. Temporarily suspend a license or delegate to the executive director the authority to temporarily suspend a license and hold a hearing before the board at the next available board meeting if both of the following occur:
(a) The licensee admits in writing to diverting a controlled substance.
(b) the board receives notification from the licensee's employer that both:
(i) Indicates that controlled substances have been diverted.
(ii) Identifies the licensee that diverted the controlled substances.
21. Issue a subpoena to do either of the following:
(a) Solicit a response either:
(i) For information pertaining to a complaint or investigation.
(ii) To a consent agreement issued by the board.
(b) Require a personal appearance before the board.
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.
D. The board may issue nondisciplinary civil penalties or delegate to the executive director the authority to issue nondisciplinary civil penalties. the nondisciplinary civil penalties shall be prescribed by the board in rule and issued using a board‑approved form. If a licensee or permittee fails to pay a nondisciplinary civil penalty that the board has imposed on it, the board shall hold a hearing on the matter. In addition to any other nondisciplinary civil penalty adopted by the board, either of the following acts or omissions that is not an imminent threat to the public health and safety is subject to a nondisciplinary civil penalty:
1. A single occurrence of either of the following, with all subsequent occurrences being presented to the board as a complaint:
(a) Failing to submit a remodel application before remodeling a permitted facility.
(b) Failing to notify the board of the relocation of a business.
2. The occurrence of any of the following violations, with three or more violations being presented to the board as a complaint:
(a) The licensee or permittee fails to update the licensee's or permittee's online profile within ten days after a change in contact information, address, telephone number or email address.
(b) The licensee fails to update the licensee's online profile within ten days after a change in employment.
(c) The licensee fails to complete the required continuing education for a license renewal.
(d) The licensee fails to update the licensee's online profile to reflect a new pharmacist in charge within fourteen days after the position change.
(e) The permittee fails to update the permittee's online profile to reflect a new designated representative within ten days after the position change.
(f) The licensee or permittee fails to notify the board of a new criminal charge, arrest or conviction against the licensee or permittee in this state or any other jurisdiction.
(g) The licensee or permittee fails to notify the board of a disciplinary action taken against the licensee or permittee by another regulating agency in this state or any other jurisdiction.
(h) A licensee or permittee fails to renew a license or permit within sixty days after the license or permit expires. If more than sixty days have lapsed after the expiration of a license or permit, the licensee or permittee shall appear before the board.
(i) A new pharmacist in charge fails to conduct a controlled substance inventory within ten days after starting the position.
(j) A licensee fails to report a theft or loss of a controlled substance within ten days after discovering the theft or loss.
(k) A person fails to obtain a permit before shipping into this state anything that requires a permit pursuant to this chapter.
E. The board shall develop substantive policy statements pursuant to section 41‑1091 for each specific licensing and regulatory authority the board delegates to the executive director.
D. F. 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. 4. Repeal
Section 32-1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 320, section 1, is repealed.
Sec. 5. Section 32-1907, Arizona Revised Statutes, is amended to read:
32-1907. Arizona state board of pharmacy fund
A. Except as provided in section 32‑1939, the executive director shall receive and receipt for all fees and other monies provided for in this chapter and shall deposit, pursuant to sections 35‑146 and 35‑147, ten percent of such monies in the state general fund and ninety percent in the Arizona state board of pharmacy fund. All monies derived from civil penalties collected pursuant to this chapter shall be deposited, pursuant to sections 35‑146 and 35‑147, in the state general fund. All monies derived from administrative fees collected from consent agreements or hearings shall be deposited in the Arizona state board of pharmacy fund.
B. Except as provided in subsection C of this section, monies deposited in the Arizona state board of pharmacy fund shall be are subject to section 35‑143.01.
C. From monies deposited in the Arizona state board of pharmacy fund pursuant to subsection A of this section, the executive director may transfer up to five hundred thousand dollars $500,000 annually to the controlled substances prescription monitoring program fund established by section 36‑2605 for expenses related to the controlled substances prescription monitoring program as required by title 36, chapter 28.
D. From monies deposited in the Arizona state board of pharmacy fund pursuant to subsection A of this section, the executive director may transfer up to one million dollars $1,000,000 annually to the Arizona poison and drug information center for the purposes specified in section 36‑1161 to supplement, and not supplant, any state general fund appropriation for those purposes.
Sec. 6. Section 32-1922, Arizona Revised Statutes, is amended to read:
32-1922. Qualifications of applicant; reciprocity; preliminary equivalency examination; honorary certificate; fee
A. An applicant for licensure as a pharmacist shall:
1. Be of good moral character.
2. Be a graduate of a school or college of pharmacy or department of pharmacy of a university recognized by the board or the accreditation council for pharmacy education, or qualify under subsection D of this section.
3. Have successfully completed, as substantiated by proper affidavits, a program of practical experience under the direct supervision of a licensed pharmacist who is approved by the board.
4. Pass the pharmacist licensure examination and jurisprudence examination approved by the board. An applicant who fails an examination three times shall petition the board for permission before retaking the examination. The board shall evaluate the petition and determine whether to require additional educational training before approving each additional retake of the examination.
5. Pay an application fee prescribed by the board of not more than five hundred dollars $500. An applicant for reciprocal licensure shall pay the fee prescribed in section 32‑1924, subsection D.
B. The board may license as a pharmacist, without a pharmacist licensure examination, a person who is licensed as a pharmacist by a pharmacist licensure examination in some other jurisdiction if that person:
1. Produces satisfactory evidence to the board of having had the required secondary and professional education and training.
2. Is possessed of good morals as demanded of applicants for licensure and relicensure under this chapter.
3. Presents proof to the board's satisfaction that the person is licensed by a pharmacist licensure examination equivalent to the pharmacist licensure examination required by the board and that the person holds the license in good standing. If the applicant was examined after June 1, 1979, the applicant must present proof to the board's satisfaction of having passed the national association of boards of pharmacy licensure examination or the north American pharmacist licensure examination.
4. Presents proof to the board's satisfaction that any other license granted to the applicant by any other jurisdiction has not been disciplined, suspended, revoked or otherwise restricted for any reason except nonrenewal or for failure to obtain the required continuing education credits in any jurisdiction where the applicant is currently licensed but not engaged in the practice of pharmacy.
5. Passes a board-approved jurisprudence examination.
C. Subsection B of this section applies only if the jurisdiction in which the person is licensed grants, under like conditions, reciprocal licensure as a pharmacist to a pharmacist who is licensed by examination in this state and the person holds a license in good standing issued by an active member board of the national association of boards of pharmacy.
D. If an applicant for licensure is a graduate of a pharmacy degree program at a school or college of pharmacy that was not recognized by the board at the time of the person's graduation, the applicant shall pass a preliminary equivalency examination approved by the board in order to qualify to take the examinations prescribed in subsection A of this section.
E. The preliminary equivalency examination required pursuant to subsection D of this section shall cover proficiency in English and academic areas the board deems essential to a satisfactory pharmacy curriculum.
F. An applicant who fails the preliminary equivalency examination required pursuant to subsection D of this section shall not retake the preliminary equivalency examination until the applicant files written proof with the board that the applicant has completed additional remedial academic work previously approved by the board to correct deficiencies in the applicant's education that were indicated by the results of the applicant's last preliminary equivalency examination.
G. A pharmacist who has been licensed in this state for at least fifty years shall be granted an honorary certificate of licensure by the board without the payment of the usual renewal fee, but that certificate of licensure does not confer an exemption from any other requirement of this chapter.
H. The board may require a pharmacist who has not been actively engaged in the practice of pharmacy for over one year to serve not more than four hundred hours in an internship training program approved by the board or its designee before the pharmacist may resume the active practice of pharmacy.
I. An applicant must complete the application process within twelve months after submitting the application.
Sec. 7. Section 32-1924, Arizona Revised Statutes, is amended to read:
32-1924. Licenses; fees; rules; signatures; online profiles
A. An applicant for licensure as a pharmacist who passes the board‑approved examinations shall pay the board an initial licensure fee of not more than five hundred dollars $500.
B. An applicant for licensure as a pharmacist, intern, or pharmacy technician or pharmacy technician trainee shall pay a fee prescribed by the board that does not exceed fifty dollars $50 for issuance of a wall license. On payment of a fee of not more than fifty dollars $50, the board may issue a replacement wall license to a licensee who requests a replacement because the original was damaged or destroyed, because of a change of name or for other good cause as prescribed by the board.
C. An applicant for licensure as an intern shall pay a fee of not more than seventy-five dollars $75. A license issued pursuant to this subsection expires five years after it is issued. The board shall adopt rules to prescribe the requirements for the renewal of a license that expires before the pharmacy intern completes the education or training required for licensure as a pharmacist.
D. An applicant for reciprocal licensure as a pharmacist shall pay a fee of not more than five hundred dollars $500 for the application and expense of making an investigation of investigating the applicant's character, general reputation and pharmaceutical standing in the jurisdiction in which the applicant is licensed.
E. All pharmacist licenses shall bear the signatures of the executive director and a majority of the members of the board.
F. An applicant for licensure as a pharmacy technician trainee shall submit with the application a fee prescribed by the board that does not exceed one hundred dollars $100. A license issued pursuant to this subsection expires thirty-six months after it is issued. A pharmacy technician trainee license may not be renewed or reissued.
G. An applicant for licensure as a pharmacy technician shall submit with the application a fee prescribed by the board that does not exceed one hundred dollars $100.
H. A licensee shall create an online profile using the board's licensing software.
Sec. 8. Section 32-1925, Arizona Revised Statutes, is amended to read:
32-1925. Renewal of license of pharmacists, interns and pharmacy technicians; fees; expiration dates; penalty for failure to renew; continuing education
A. Except for interns and pharmacy technician trainees, the board shall assign all persons who are licensed under this chapter to one of two license renewal groups. Except as provided in section 32‑4301, a holder of a license certificate designated in the licensing database as even by way of verbiage or numerical value shall renew it biennially on or before November 1 of the even-numbered year, two years from after the last renewal date. Except as provided in section 32‑4301, a holder of a license certificate designated in the licensing database as odd by way of verbiage or numerical value shall renew it biennially on or before November 1 of the odd‑numbered year, two years from after the last renewal date. Failure to renew and pay all required fees on or before November 1 of the year in which the renewal is due suspends the license. The board shall vacate a suspension when the licensee pays all past due fees and reinstatement penalties. Reinstatement penalties shall not exceed three hundred fifty dollars $350. The board may waive collection of a fee or reinstatement penalty due after suspension under conditions established by a majority of the board.
B. A person shall not apply for license renewal more than sixty days before the expiration date of the license.
C. A person who is licensed as a pharmacist or a pharmacy technician and who has not renewed the license for five consecutive years shall furnish to the board satisfactory proof of fitness to be licensed as a pharmacist or a pharmacy technician. , in addition to the payment of all past due fees A person whose license has lapsed for two or more renewal cycles shall pay the fees for the two most recent renewal cycles and the penalties before being reinstated.
D. Biennial renewal fees for licensure shall be not more than:
1. For a pharmacist, two hundred fifty dollars $250.
2. For a pharmacy technician, one hundred dollars $100.
3. For a duplicate renewal license, twenty‑five dollars $25.
E. Fees that are designated to be not more than a maximum amount shall be set by the board for the following two fiscal years beginning November 1. The board shall establish fees approximately proportionate to the maximum fee allowed to cover the board's anticipated expenditures for the following two fiscal years. Variation in a fee is not effective except at the expiration date of a license.
F. The board shall not renew a license for a pharmacist unless the pharmacist has complied with the mandatory continuing professional pharmacy education requirements of sections 32‑1936 and 32‑1937.
G. The board shall prescribe intern licensure renewal fees that do not exceed seventy‑five dollars $75. The license of an intern who does not receive specific board approval to renew the intern license or who receives board approval to renew but who does not renew and pay all required fees before the license expiration date is suspended after the license expiration date. The board shall vacate a suspension if the licensee pays all past due fees and penalties. Penalties shall not exceed three hundred fifty dollars $350. The board may waive collection of a fee or penalty due after suspension under conditions established by the board.
H. The board shall not renew a license for a pharmacy technician unless that person has a current board-approved license and has complied with board‑approved mandatory continuing professional education requirements. If a pharmacy technician prepares, compounds or dispenses prescription medications at a remote dispensing site pharmacy, the pharmacy technician shall complete, in addition to any other board‑approved mandatory continuing professional education requirements, a two‑hour continuing education program on remote dispensing site pharmacy practices provided by an approved provider.
Sec. 9. Section 32-1927, Arizona Revised Statutes, is amended to read:
32-1927. Pharmacists; pharmacy interns; disciplinary action
A. A pharmacist or pharmacy intern is subject to disciplinary action by the board for any of the following:
1. The board determines that the licensee has committed an act of unprofessional conduct.
2. The licensee is found by psychiatric examination to be mentally unfit to practice the profession of pharmacy.
3. The licensee is found to be physically or mentally incapacitated to such a degree as to render the licensee unfit to practice the profession of pharmacy.
4. The licensee is found to be professionally incompetent to such a degree as to render the licensee unfit to practice the profession of pharmacy.
5. The license was issued through error.
B. A pharmacist or pharmacy intern who after a formal hearing is found by the board to be guilty of unprofessional conduct, to be mentally or physically unable safely to engage in the practice of pharmacy or to be professionally incompetent is subject to any one or combination of the following:
1. A civil penalty of not to exceed one thousand dollars more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
2. A letter of reprimand.
3. A decree of censure.
4. Completion of board‑designated continuing pharmaceutical education courses.
5. Probation.
6. Suspension or revocation of the license.
C. The board may charge the costs of formal hearings to the licensee whom it finds to be in violation of this chapter or a rule adopted under this chapter.
D. The board on its own motion may investigate any evidence that appears to show that a pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the practice of pharmacy. Any person may, and a licensee or permittee of the board must, report to the board any information that appears to show that a pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the practice of pharmacy. The board or the executive director shall notify the pharmacist or pharmacy intern as to the content of the complaint as soon as reasonable. Any person or entity that reports or provides information to the board in good faith is not subject to an action for civil damages. It is an act of unprofessional conduct for any pharmacist or pharmacy intern to fail to report as required by this subsection.
E. The pharmacy permittee or pharmacist in charge of a pharmacy located in this state must inform the board if a pharmacist or pharmacy intern employed by the pharmacy is terminated because of actions by the pharmacist or pharmacy intern that appear to show that the pharmacist or pharmacy intern is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the practice of pharmacy, along with a general statement of the reasons that led the pharmacy to take the action. The pharmacy permittee or pharmacist in charge of a pharmacy located in this state must inform the board if a pharmacist or pharmacy intern under investigation resigns or if a pharmacist or pharmacy intern resigns in lieu of disciplinary action by the pharmacy. Notification must include a general statement of the reasons for the resignation. A person who reports information in good faith pursuant to this subsection is not subject to civil liability.
F. The board or, if delegated by the board, the executive director shall require any combination of mental, physical, psychological, psychiatric or medical competency examinations or pharmacist licensure examinations and conduct necessary investigations, including investigational interviews between representatives of the board and the pharmacist or pharmacy intern, to fully inform itself about any information filed with the board under this section. These examinations may also include biological fluid testing. The board may require the pharmacist or pharmacy intern, at that person's expense, to undergo assessment by a board‑approved substance abuse treatment and rehabilitation program.
G. If after completing its investigation the board finds that the information provided pursuant to this section is not of sufficient seriousness to merit disciplinary action against the license of the pharmacist or pharmacy intern, the board may take any of the following actions:
1. Dismiss if the complaint is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after receiving the advisory letter.
3. Require the licensee to complete board‑designated continuing pharmaceutical education courses.
H. The board shall not disclose the name of the person who provides information regarding a licensee's drug or alcohol impairment or the name of the person who files a complaint if that person requests anonymity.
I. If the board determines pursuant to an investigation that reasonable grounds exist to discipline a licensee under this section, the board may serve the licensee with a written notice that states all of the following:
1. That the board has sufficient evidence that, if not rebutted or explained, will justify the board in taking disciplinary actions allowed by this chapter.
2. The nature of the allegations asserted and the specific statutes or rules that the licensee is alleged to have violated.
3. That unless the licensee submits a written request for a hearing within thirty days after service of the notice by certified mail, the board may deem the allegations admitted and may take any disciplinary action allowed pursuant to this chapter without conducting a hearing.
I. J. If after completing its investigation the board believes that the information is or may be true, it the board may request a conference with the pharmacist or pharmacy intern. If the pharmacist or pharmacy intern refuses the invitation for a conference and the investigation indicates that grounds may exist for revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, the board shall issue a formal notice that a hearing be held pursuant to title 41, chapter 6, article 10.
J. K. If through information provided pursuant to this section or by other means the board finds that the protection of the public health, welfare and safety requires emergency action against the license of a pharmacist or pharmacy intern, the board may restrict a license or order a summary suspension of a license pending proceedings for revocation or other action. If the board acts pursuant to this subsection, the board shall also serve the licensee with a written notice of complaint and formal hearing that sets forth the charges and licensee's right to a formal hearing before the board or an administrative law judge on the charges within sixty days pursuant to title 41, chapter 6, article 10.
K. L. If after completing the conference the board finds the information provided pursuant to this section is not of sufficient seriousness to merit revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after the licensee receives the advisory letter.
3. Require the licensee to complete board‑designated continuing pharmaceutical education courses.
L. M. If during a conference the board finds that the information provided pursuant to this section indicates that grounds may exist for revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after the licensee receives the advisory letter.
3. Require the licensee to complete board‑designated continuing pharmaceutical education courses.
4. Enter into an agreement with the licensee to discipline the licensee, restrict the licensee's practice or professional activities or rehabilitate, retrain or assess the licensee in order to protect the public and ensure the licensee's ability to safely engage in the practice of pharmacy. The agreement may include at least the following:
(a) Issuance of a letter of reprimand.
(b) Issuance of a decree of censure.
(c) Practice or professional restrictions, such as not acting as a pharmacist in charge or pharmacy intern preceptor or working with another pharmacist.
(d) Rehabilitative, retraining or assessment programs, including:
(i) Board‑approved community service.
(ii) Successful completion of additional board‑designated continuing pharmaceutical education courses.
(iii) Successful passage of board‑approved pharmacist licensure examinations.
(iv) Successful completion of a board‑approved substance abuse treatment and rehabilitation program at the licensee's own expense.
(e) A civil penalty not to exceed one thousand dollars of not more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
(f) A period and terms of probation best adapted to protect the public health and safety and rehabilitate or educate the licensee concerned. Probation may include temporary suspension and any or all of the disciplinary actions, practice or professional restrictions, rehabilitative, retraining or assessment programs listed in this section or any other program agreed to by the board and the licensee.
M. N. If the board finds that the information provided pursuant to this section and additional information provided during the conference warrants revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it shall initiate formal proceedings pursuant to title 41, chapter 6, article 10.
N. O. If the licensee wishes to be present at the formal hearing in person or by representation, or both, the licensee must file with the board an answer to the charges in the notice of hearing. The answer must be in writing, be verified under oath and be filed within thirty days after service of the notice of hearing. Failure to answer the board's notice of hearing is deemed an admission of the charges in the notice of hearing.
O. P. An advisory letter is a nondisciplinary public document.
P. Q. If the board during an investigation determines that a criminal violation might have occurred, it the board shall disclose its investigative evidence and information to the appropriate criminal justice agency for its consideration.
Q. R. In determining the appropriate disciplinary action under this section, the board shall consider all previous nondisciplinary and disciplinary actions against a licensee.
R. S. The board may deny a license to an applicant for the grounds prescribed in subsection A of this section.
S. T. A person who is licensed pursuant to this chapter or by any other jurisdiction and who has a license revoked or suspended shall not obtain a license as a pharmacy intern, pharmacy technician or pharmacy technician trainee or work as a pharmacy intern, pharmacy technician or pharmacy technician trainee without the approval of the board or its designee.
U. Failure to acknowledge or reply to the board before the deadline regarding a consent agreement for voluntary surrender or voluntary suspension issued by the board or board staff shall result in the acceptance of the finding of fact, the conclusion of law and the board order by the licensee only after the board has communicated to the licensee using the mailing address, email address and telephone number on file and, if applicable, the licensee's attorney of reference. The licensee may request a rehearing or review and appeal of the decision.
V. If after a board order or an agreed consent agreement is in effect and the licensee fails to comply with the order, the board, or the executive director if delegated to the executive director, may move that case without opening a new compliant for noncompliance to a board hearing to consider action on the license, including revocation.
Sec. 10. Section 32-1927.01, Arizona Revised Statutes, is amended to read:
32-1927.01. Pharmacy technicians; pharmacy technician trainees; disciplinary action
A. A pharmacy technician or pharmacy technician trainee is subject to disciplinary action by the board for any of the following:
1. The board determines that the licensee has committed an act of unprofessional conduct.
2. The licensee is found by psychiatric examination to be mentally unfit to safely perform the licensee's employment duties.
3. The licensee is found to be physically or mentally incapacitated to such a degree as to render the licensee unfit to safely perform the licensee's employment duties.
4. The licensee is found to be professionally incompetent to such a degree as to render the licensee unfit to safely perform the licensee's employment duties.
5. The license was issued through error.
B. A pharmacy technician or pharmacy technician trainee who after a formal hearing is found by the board to be guilty of unprofessional conduct, to be mentally or physically unable safely to engage in the practice of pharmacy or to be professionally incompetent is subject to any one or combination of the following:
1. A civil penalty of not to exceed one thousand dollars more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
2. A letter of reprimand.
3. A decree of censure.
4. Completion of board designated continuing education courses.
5. Probation.
6. Suspension or revocation of the license.
C. The board may charge the costs of formal hearings to the licensee whom it finds to be in violation of this chapter or a rule adopted under this chapter.
D. The board on its own motion may investigate any evidence that appears to show that a pharmacy technician or pharmacy technician trainee is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the permissible activities of a pharmacy technician or pharmacy technician trainee. Any person may, and a licensee or permittee of the board must, report to the board any information that appears to show that a pharmacy technician or pharmacy technician trainee is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the permissible activities of a pharmacy technician or pharmacy technician trainee. The board or the executive director shall notify the pharmacy technician or pharmacy technician trainee as to the content of the complaint as soon as reasonable. Any person or entity that reports or provides information to the board in good faith is not subject to an action for civil damages. It is an act of unprofessional conduct for any pharmacy technician or pharmacy technician trainee to fail to report as required by this subsection.
E. The pharmacy permittee or pharmacist in charge of a pharmacy located in this state must inform the board if a pharmacy technician or pharmacy technician trainee employed by the pharmacy is terminated because of actions by that person that appear to show that the person is or may be professionally incompetent, is or may be guilty of unprofessional conduct or is or may be mentally or physically unable safely to engage in the permissible activities of a pharmacy technician or pharmacy technician trainee, along with a general statement of the reasons that led the pharmacy to take the action. The pharmacy permittee or pharmacist in charge of a pharmacy located in this state must inform the board if a pharmacy technician or pharmacy technician trainee under investigation resigns or if a pharmacy technician or pharmacy technician trainee resigns in lieu of disciplinary action by the pharmacy. Notification must include a general statement of the reasons for the resignation. A person who reports information in good faith pursuant to this subsection is not subject to civil liability.
F. The board or, if delegated by the board, the executive director shall require any combination of mental, physical, psychological, psychiatric or medical competency examinations or pharmacy technician licensure examinations and conduct necessary investigations, including investigational interviews between representatives of the board and the pharmacy technician or pharmacy technician trainee, to fully inform itself about any information filed with the board pursuant to this section. These examinations may also include biological fluid testing. The board may require the licensee, at that person's expense, to undergo assessment by a board approved substance abuse treatment and rehabilitation program.
G. If after completing its investigation the board finds that the information provided pursuant to this section is not of sufficient seriousness to merit disciplinary action against the license of the pharmacy technician or pharmacy technician trainee, the board may take any of the following actions:
1. Dismiss if the complaint is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after receiving the advisory letter.
3. Require the licensee to complete board designated continuing pharmaceutical education courses.
H. The board shall not disclose the name of the person who provides information regarding a licensee's drug or alcohol impairment or the name of the person who files a complaint if that person requests anonymity.
I. If the board determines pursuant to an investigation that reasonable grounds exist to discipline a licensee under this section, the board may serve the licensee with a written notice that states:
1. That the board has sufficient evidence that, if not rebutted or explained, will justify the board in taking disciplinary actions allowed by this chapter.
2. The nature of the allegations asserted and the specific statutes or rules that the licensee is alleged to have violated.
3. That unless the licensee submits a written request for a hearing within thirty days after service of the notice by certified mail, the board may deem the allegations admitted and may take any disciplinary action allowed pursuant to this chapter without conducting a hearing.
I. J. If after completing its investigation the board believes that the information is or may be true, it the board may request a conference with the licensee. If the licensee refuses the invitation for a conference and the investigation indicates that grounds may exist for revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, the board shall issue a formal notice that a hearing be held pursuant to title 41, chapter 6, article 10.
J. K. If through information provided pursuant to this section or by other means the board finds that the protection of the public health, welfare and safety requires emergency action against the license of a pharmacy technician or pharmacy technician trainee, the board may restrict a license or order a summary suspension of a license pending proceedings for revocation or other action. If the board acts pursuant to this subsection, the board shall also serve the licensee with a written notice of complaint and formal hearing that sets forth the charges made against the licensee and the licensee's right to a formal hearing before the board or an administrative law judge on the charges within sixty days pursuant to title 41, chapter 6, article 10.
K. L. If after completing the conference the board finds the information provided pursuant to this section is not of sufficient seriousness to merit revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after the licensee receives the advisory letter.
3. Require the licensee to complete board designated continuing pharmaceutical education courses.
L. M. If during a conference the board finds that the information provided pursuant to this section indicates that grounds may exist for revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The licensee may file a written response with the board within thirty days after the licensee receives the advisory letter.
3. Require the licensee to complete board designated continuing pharmaceutical education courses.
4. Enter into an agreement with the licensee to discipline the licensee, restrict the licensee's practice or professional activities or rehabilitate, retrain or assess the licensee in order to protect the public and ensure the licensee's ability to safely engage in the permissible activities of a pharmacy technician or pharmacy technician trainee. The agreement may include at least the following:
(a) Issuance of a letter of reprimand.
(b) Issuance of a decree of censure.
(c) Practice or professional restrictions, such as doing the following only under pharmacist supervision:
(i) Entering prescription or patient data.
(ii) Initiating or accepting verbal refill authorization.
(iii) Counting, pouring, packaging or labeling prescription medication.
(iv) Compounding, reconstituting, prepackaging or repackaging drugs.
(d) Rehabilitative, retraining or assessment programs, including:
(i) Board approved community service.
(ii) Successful completion of additional board designated continuing pharmaceutical education courses.
(iii) Successful passage of board approved pharmacist technician licensure examinations.
(iv) Successful completion of a board approved substance abuse treatment and rehabilitation program at the licensee's own expense.
(e) A civil penalty not to exceed one thousand dollars of not more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
(f) A period and terms of probation best adapted to protect the public health and safety and rehabilitate or educate the licensee concerned. Probation may include temporary suspension and any or all of the disciplinary actions, practice or professional restrictions, rehabilitative, retraining or assessment programs listed in this section or any other program agreed to by the board and the licensee.
M. N. If the board finds that the information provided pursuant to this section and additional information provided during the conference warrants revocation or suspension of a license, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it shall initiate formal proceedings pursuant to title 41, chapter 6, article 10.
N. O. If the licensee wishes to be present at the formal hearing in person or by representation, or both, the licensee must file with the board an answer to the charges in the notice of hearing. The answer must be in writing, be verified under oath and be filed within thirty days after service of the notice of hearing. Failure to answer the board's notice of hearing is deemed an admission of the charges in the notice of hearing.
O. P. An advisory letter is a nondisciplinary public document.
P. Q. If the board during an investigation determines that a criminal violation might have occurred, it the board shall disclose its investigative evidence and information to the appropriate criminal justice agency for its consideration.
Q. R. In determining the appropriate disciplinary action under this section, the board shall consider all previous nondisciplinary and disciplinary actions against a licensee.
R. S. The board may deny a license to an applicant for the grounds prescribed in subsection A of this section.
S. T. A person licensed pursuant to this chapter or by any other jurisdiction who has a license revoked or suspended shall not obtain a license as a pharmacy technician or pharmacy technician trainee or work as a pharmacy technician or pharmacy technician trainee without the approval of the board or its designee.
U. Failure to acknowledge or reply to the board before the deadline regarding a consent agreement for voluntary surrender or voluntary suspension issued by the board or board staff shall result in the acceptance of the finding of fact, the conclusion of law and the board order by the licensee only after the board has communicated to the licensee using the mailing address, email address and telephone number on file and, if applicable, the licensee's attorney of reference. The licensee may request a rehearing or review and appeal of the decision.
V. If after a board order or an agreed consent agreement is in effect and the licensee fails to comply with the order, the board, or the executive director if delegated to the executive director, may move that case without opening a new compliant for noncompliance to a board hearing to consider action on the license, including revocation.
Sec. 11. Section 32-1927.02, Arizona Revised Statutes, is amended to read:
32-1927.02. Permittees; disciplinary action
A. The board may discipline a permittee if:
1. The board determines that the permittee or permittee's employee is guilty of unethical conduct pursuant to section 32‑1901.01, subsection A.
2. Pursuant to a psychiatric examination, the permittee or the permittee's employee is found to be mentally unfit to safely engage in employment duties.
3. The board determines that the permittee or the permittee's employee is physically or mentally incapacitated to such a degree as to render the permittee or permittee's employee unfit to safely engage in employment duties.
4. The permit was issued through error.
5. A permittee or permittee's employee allows a person who does not possess a current license issued by the board to work as a pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee.
B. A permittee who after a formal hearing is found by the board to be guilty of unethical conduct, to be mentally or physically unable safely to engage in employment duties or to be in violation of this chapter or a rule adopted under this chapter or whose employee after a formal hearing is found by the board to be guilty of unethical conduct, to be mentally or physically unable safely to engage in employment duties or to be in violation of this chapter or a rule adopted under this chapter is subject to any one or combination of the following:
1. A civil penalty not to exceed one thousand dollars of not more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
2. A letter of reprimand.
3. A decree of censure.
4. Completion of board‑designated pharmacy law continuing education courses.
5. Probation.
6. Suspension or revocation of the permit.
C. The board may charge the costs of formal hearings to the permittee whom it finds to be in violation of this chapter or a rule adopted under this chapter or whose employee it finds to be in violation of this chapter or a rule adopted under this chapter.
D. The board on its own motion may investigate any evidence that appears to show that a permittee or permittee's employee is or may be guilty of unethical conduct, is or may be mentally or physically unable safely to engage in employment duties or is or may be in violation of this chapter or a rule adopted under this chapter. Any person may, and any licensee or permittee must, report to the board any information that appears to show that a permittee or permittee's employee is or may be guilty of unethical conduct, is or may be mentally or physically unable safely to engage in employment duties or is or may be in violation of this chapter or a rule adopted under this chapter. The board or the executive director shall notify the permittee as to the content of the complaint as soon as reasonable. Any person or entity that reports or provides information to the board in good faith is not subject to an action for civil damages. It is an act of unethical conduct for any permittee to fail to report as required by this subsection.
E. The board or, if delegated by the board, the executive director shall require any combination of mental, physical, psychological, psychiatric or medical competency examinations and conduct necessary investigations, including investigational interviews between representatives of the board and the permittee or permittee's employee, to fully inform itself about any information filed with the board under subsection D of this section. These examinations may also include biological fluid testing. The board may require the permittee or permittee's employee, at that person's expense, to undergo assessment by a board‑approved substance abuse treatment and rehabilitation program.
F. If after completing its investigation the board finds that the information provided pursuant to subsection D of this section is not of sufficient seriousness to merit disciplinary action against the permit, the board may take any of the following actions:
1. Dismiss if the complaint is without merit.
2. File an advisory letter. The permittee may file a written response with the board within thirty days after receiving the advisory letter.
3. Require the permittee to complete board‑designated pharmacy law continuing education courses.
G. The board shall not disclose the name of the person who provides information regarding a permittee's or permittee's employee's drug or alcohol impairment or the name of the person who files a complaint if that person requests anonymity.
H. If the board determines pursuant to an investigation that reasonable grounds exist to discipline a permittee or permittee's employee under this section, the board may serve the permittee or permittee's employee with a written notice that states:
1. That the board has sufficient evidence that, if not rebutted or explained, will justify the board in taking disciplinary actions allowed by this chapter.
2. The nature of the allegations asserted and the specific statutes or rules that the permittee or permittee's employee is alleged to have violated.
3. That unless the permittee or permittee's employee submits a written request for a hearing within thirty days after service of the notice by certified mail, the board may deem the allegations admitted and may take any disciplinary action allowed pursuant to this chapter without conducting a hearing.
H. I. If after completing its investigation the board believes that the information is or may be true, it the board may request a conference with the permittee or permittee's employee. If the permittee or permittee's employee refuses the invitation for a conference and the investigation indicates that grounds may exist for revocation or suspension of a permit, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, the board shall issue a formal notice that a hearing be held pursuant to title 41, chapter 6, article 10.
I. J. If through information provided pursuant to subsection D of this section or by other means the board finds that the protection of the public health, welfare and safety requires emergency action against the permit, the board may restrict a permit or order a summary suspension of a permit pending proceedings for revocation or other action. If the board acts pursuant to this subsection, the board shall also serve the permittee with a written notice of complaint and formal hearing that sets forth the charges and the permittee's right to a formal hearing on the charges before the board or an administrative law judge within sixty days pursuant to title 41, chapter 6, article 10.
J. K. If after completing the conference the board finds the information provided pursuant to subsection D of this section is not of sufficient seriousness to merit revocation or suspension of a permit, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The permittee may file a written response with the board within thirty days after receiving the advisory letter.
3. Require the permittee to complete board‑designated pharmacy law continuing education courses.
K. L. If during a conference the board finds that the information provided pursuant to subsection D of this section indicates that grounds may exist for revocation or suspension of a permit, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board may take the following actions:
1. Dismiss if the information is without merit.
2. File an advisory letter. The permittee may file a written response with the board within thirty days after the permittee receives the advisory letter.
3. Require the permittee to complete board‑designated pharmacy law continuing education courses.
4. Enter into an agreement with the permittee to discipline the permittee, restrict the permittee's business activities or rehabilitate or assess the permittee in order to protect the public and ensure the permittee's ability to safely engage in employment duties. The agreement may include, at a minimum, the following disciplinary actions, business activity restrictions and rehabilitative or assessment programs:
(a) Issuance of a letter of reprimand.
(b) Issuance of a decree of censure.
(c) Business activity restrictions, including limitations on the number, type, classification or schedule of drug, device, poison, hazardous substance, controlled substance or precursor chemical that may be manufactured, sold, distributed or dispensed.
(d) Successful completion of board‑designated pharmacy law continuing education courses.
(e) Rehabilitative or assessment programs, including board‑approved community service or successful completion of a board‑approved substance abuse treatment and rehabilitation program at the permittee's own expense.
(f) A civil penalty not to exceed one thousand dollars of not more than $1,000 for each violation of this chapter or a rule adopted under this chapter.
(g) A period and terms of probation best adapted to protect the public health and safety and rehabilitate or assess the permittee concerned. Probation may include temporary suspension and any or all of the disciplinary actions, business practice restrictions, rehabilitative or assessment programs listed in this section or any other program agreed to by the board and the permittee.
L. M. If the board finds that the information provided pursuant to subsection D of this section and additional information provided during the conference indicate that grounds may exist for revocation or suspension of a permit, probation, issuance of a decree of censure or a letter of reprimand or imposition of a civil penalty, it the board shall initiate formal proceedings pursuant to title 41, chapter 6, article 10.
M. N. If the permittee wishes to be present at the formal hearing in person or by representation, or both, the permittee must file with the board an answer to the charges in the notice of hearing. The answer must be in writing, be verified under oath and be filed within thirty days after service of the notice of hearing. Failure to answer the board's notice of hearing is deemed an admission of the charges in the notice of hearing.
N. O. If the board, during any investigation, determines that a criminal violation might have occurred, it the board shall disclose its investigative evidence and information to the appropriate criminal justice agency for its consideration.
O. P. In determining the appropriate disciplinary action under this section, the board shall consider all previous nondisciplinary and disciplinary actions against a permittee.
P. Q. The board may deny a permit to an applicant for the grounds prescribed in subsection A of this section.
Q. R. If the board approves a permit and the business fails to become operational within nine months after the date the permit is granted, the permit is no longer valid. The board may grant a onetime extension for the business to become operational.
Sec. 12. Section 32-1927.03, Arizona Revised Statutes, is amended to read:
32-1927.03. Persons required to be permitted; formal hearing; disciplinary action
A. A person that resides in this state or in any other jurisdiction and that sells a narcotic or other controlled substance, a prescription‑only drug or device, a nonprescription drug, a precursor chemical or a restricted chemical within or into this state shall hold a valid board‑issued permit. If the person does not hold a valid board‑issued permit, the person is subject to disciplinary action by the board.
B. A person that resides in any other jurisdiction or country that manufactures or is contracted to manufacture for another person a narcotic or other controlled substance, a prescription‑only drug or a nonprescription drug to be sold in this state shall be registered with the United States food and drug administration and hold a valid board‑issued permit as prescribed in rule by the board.
B. C. A person that after a formal hearing is found by the board to be in violation of subsection A or B of this section may be subject to a civil penalty not to exceed one thousand dollars of not more than $1,000 for each violation of this chapter or a rule adopted pursuant to this chapter.
C. D. The board may charge the cost of a formal hearing to the person that the board finds to be in violation of this chapter or a rule adopted pursuant to this chapter or whose employee the board finds to be in violation of this chapter or a rule adopted pursuant to this chapter.
D. E. The board on its own motion or in response to a complaint may inspect or investigate, or delegate to the executive director the authority to inspect or investigate, any evidence that appears to show a person is or may be acting in violation of subsection A or B of this section. The board may:
1. Send, or delegate to the executive director the authority to send, a cease and desist letter regarding the person's unauthorized business in this state.
2. Request a conference with the person if the board believes the information is or may be true. If the person refuses the invitation or fails to appear for the conference and the investigation indicates that grounds may exist for the board to impose a civil penalty, the board shall issue a formal notice that a hearing be held pursuant to title 41, chapter 6, article 10.
3. Dismiss the complaint if the complaint is without merit.
Sec. 13. Section 32-1930, Arizona Revised Statutes, is amended to read:
32-1930. Types of permits; restrictions on permits; discontinuance of pharmacy permit
A. On application, the board may issue the following classes or kinds of permits:
1. If approved by the board, a pharmacy, limited service pharmacy, automated prescription‑dispensing kiosk, full service wholesale drug, third‑party logistics provider, nonprescription drug wholesale and drug manufacturer's permit.
2. Drug packager or drug prepackager permit to an individual or establishment that is currently listed by the United States food and drug administration and has met the requirements of that agency to purchase, repackage, relabel or otherwise alter the manufacturer's original package of an approved drug product with the intent of reselling these items to persons or businesses authorized to possess or resell the repackaged, prepackaged or relabeled drug.
3. A durable medical equipment distributor and compressed medical gas distributor permit and a durable medical equipment supplier and compressed medical gas supplier permit.
B. The board shall deny or revoke a pharmacy permit if a medical practitioner receives compensation, either directly or indirectly, from a pharmacy as a result of the practitioner's prescription orders. This does not include compensation to a medical practitioner who is the owner of a building where space is leased to a pharmacy at the prevailing rate, not resulting in a rebate to the medical practitioner.
C. If a pharmacy permanently discontinues operation, the permittee shall immediately surrender the permit to the executive director. The permittee shall remove all drug signs and symbols, either within or without the premises, and shall remove or destroy all drugs, devices, poisons and hazardous substances.
D. An automated prescription‑dispensing kiosk may not contain or dispense a controlled substance as defined in section 36‑2501 and the controlled substances act (P.L. 91‑513; 84 Stat. 1242; 21 United States Code section 802).
Sec. 14. Section 32-1931, Arizona Revised Statutes, is amended to read:
32-1931. Permit fees; issuance; expiration; renewals; online profiles
A. The board shall assign the permit of all persons or firms issued under this chapter to one of two permit renewal groups. Except as provided in section 32‑4301, a holder of a permit designated in the licensing database as even by way of verbiage or numerical value shall renew it biennially on or before November 1 of the even‑numbered year, two years from after the last renewal date. Except as provided in section 32‑4301, a holder of a permit designated in the licensing database as odd by way of verbiage or numerical value shall renew it biennially on or before November 1 of the odd‑numbered year, two years from after the last renewal date. Failure to renew and pay all required fees on or before November 1 of the year in which the renewal is due suspends the permit. The board shall vacate a suspension when the permittee pays penalties of not to exceed $350 and all past due fees. The board may waive collection of a fee or penalty due after suspension under conditions established by a majority of the board.
B. Permit fees that are designated to be not more than a maximum amount shall be set by the board for the following two fiscal years beginning November 1. The board shall establish the fees approximately proportionate to the maximum fee allowed to cover the board's anticipated expenditures for the following two fiscal years. Variation in a fee is not effective except at the expiration date of the permit.
C. Applications for permits shall be accompanied by the following biennial fees as determined by pursuant to subsection B of this section:
1. A drug manufacturer's permit, not more than $1,000.
2. A pharmacy permit, not more than $500.
3. A limited service pharmacy permit or an automated prescription‑dispensing kiosk permit, not more than $500.
4. A full service wholesale drug permit or a third‑party logistics provider permit, not more than $1,000.
5. A nonprescription drug wholesale permit, not more than $500.
6. A drug repackager's permit, not more than $1,000.
7. A durable medical equipment distributor and compressed medical gas distributor permit, not more than $200.
8. A durable medical equipment supplier and compressed medical gas supplier permit, not more than $100.
D. If an applicant is found to be satisfactory to the board, the executive director shall issue to the applicant a permit for each pharmacy, manufacturer, wholesaler or other place of business in which drugs are sold, manufactured, compounded, dispensed, stocked, exposed or offered for sale, for which application is made.
E. Permits issued under this section are not transferable.
F. If a permittee does not apply for renewal, the permit expires pursuant to subsection A of this section. A person may activate and renew an expired permit by filing the required application and fee. Renewal thirty days after the expiration date of a permit may be made only on payment of the required biennial renewal fee, all past due fees and a penalty of one‑half of the amount of the applicable biennial renewal fee. The board may waive the collection of a fee or penalty due after suspension pursuant to conditions prescribed by the board.
G. A permittee shall create an online profile using the board's licensing software.
Sec. 15. Section 32-1937, Arizona Revised Statutes, is amended to read:
32-1937. Exceptions to continuing education requirements
A. The requirements of continuing professional pharmacy education provided in section 32‑1936 do not apply to licensees during the year of their graduation from an accredited college of pharmacy beginning the date of initial licensure until the date of the first license renewal.
B. The board may make exceptions from the requirements of section 32‑1936 in emergency or hardship cases or for good cause shown based on a written request for an exception from the requirements.
C. Pharmacists who are exempted from the requirements of continuing professional pharmacy education pursuant to subsection B of this section shall satisfactorily pass a written examination approved by the board for such that purpose prior to before license renewal.
Sec. 16. Section 32-1965, Arizona Revised Statutes, is amended to read:
32-1965. Prohibited acts
The following acts or the causing of any thereof of the following acts, in addition to any others so specified in this chapter, are prohibited:
1. The manufacture, sale Manufacturing, selling, holding or offering for sale of any drug, device, poison, or hazardous substance that is adulterated or misbranded.
2. The adulteration Adultering or misbranding of any drug, device, poison, or hazardous substance.
3. The alteration, mutilation, destruction, obliteration, or removal of the whole Altering, mutilating, destroying, obliterating or removing all or any part of the labeling label of, or the doing of any other act with respect to, a drug, device, poison, or hazardous substance, if such the act is done while such the article is held for sale and results in such the article being adulterated or misbranded.
4. The manufacture, sale Manufacturing, selling, holding or offering for sale of a counterfeit drug or forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under the provisions of this chapter, or of the federal act.
5. The Using, on the labeling label of any drug or device, or in any advertisement, relating to such drug or device, of any representation or suggestion that such the drug or device complies with the provisions of this chapter.
6. In the case of a prescription‑only drug or a controlled substance that requires a prescription order by state or federal law, the failure of the manufacturer, packer, or distributor to transmit, to any medical practitioner who makes a written request for information about such drug, true and correct copies of all printed matter included in any package in which that drug is distributed or other printed matter approved under the federal act.
7. Engaging in the practice of pharmacy without first having a current license in good standing issued by the board.
8. Making or offering to make a forged, counterfeit, altered or photocopied prescription or drug order for the purpose of obtaining prescription‑only drugs or controlled substance drugs substances.
9. The wholesale or distribution of prescription drugs or devices, controlled substances, nonprescription drugs, medical gas or durable medical equipment without a valid board‑issued permit.
10. In the case of a manufacturer, manufacturing, possessing or shipping into this state manufactured prescription drugs or devices, controlled substances, nonprescription drugs, precursor chemicals or any other regulated chemical without a valid board‑issued permit.
Sec. 17. Section 32-1967, Arizona Revised Statutes, is amended to read:
32-1967. Acts constituting misbranding of a drug or device; exceptions; interpretation of misleading label; definition
A. A drug or device is misbranded:
1. If its labeling is false or misleading in any particular.
2. If in package form unless it bears a label containing both:
(a) The name and place of business of the manufacturer, packer or distributor.
(b) An accurate statement of the quantity of the contents in terms of weight, measure or numerical count.
3. If any word, statement or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed on the label or labeling. Compliance with the federal act shall be deemed compliance with this chapter except for compliance with paragraph 16 of this subsection.
4. If it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha‑eucaine, barbituric acid, beta‑eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulfonmethane, or any chemical derivative of such substance, which derivative or other substance has been found to be habit‑forming, unless its label bears the name and quantity or proportion of such substance or derivative.
5. If it is a drug unless its label bears, to the exclusion of any other nonproprietary name, both:
(a) The established name of the drug, if there is an established name.
(b) In case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, mercury, strychnine or thyroid, or derivative or preparation of any such substances, provided that the requirements for stating the quantity of the active ingredients, other than those specifically named in this subdivision, apply only to prescription drugs.
6. Unless its labeling bears both:
(a) Adequate directions for use.
(b) Adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in a manner and form as are necessary for the protection of users.
7. If it is recognized in an official compendium, unless it is packed and labeled as prescribed in such compendium, provided that the method of packing may be modified with the consent of the board.
8. If it has been found by the board to be a drug or device liable to deterioration, unless it is packaged in that form and manner, and its label bears a statement of such precautions, as the rules issued by the board require as necessary for the protection of public health.
9. If its container is so made, formed or filled as to be misleading.
10. If it is an imitation of another drug or device.
11. If it is offered for sale under the name of another drug or device.
12. If it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug or device.
13. If it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive in the federal act or board rule.
14. In the case of any prescription‑only drug or controlled substance distributed or offered for sale in this state, unless the manufacturer, packer or distributor of such drug or substance includes in all advertisements and other printed matter with respect to that drug a true statement of:
(a) The established name.
(b) The formula showing quantitatively each ingredient.
(c) Other information in brief summary relating to side effects, contraindications or effectiveness as required in board rules or the federal act.
15. If a trademark, trade name or other identifying mark, imprint or device of another drug or device or any likeness of another drug or device has been placed on the drug or device or on its container with intent to defraud.
16. In the case of any prescription‑only drug or controlled substance, if in final dosage form unless it bears a label containing both:
(a) The name and place of business of the manufacturer, and if different, the packer or distributor.
(b) An accurate statement of the quantity of the contents in terms of weight, measure or numerical count.
17. In the case of any foreign dangerous drug, if it is not approved by the United States food and drug administration or is obtained outside of the licensed supply chain regulated by the United States food and drug administration, the board or the department of health services. This paragraph does not apply to a foreign dangerous drug that is authorized for use by a state law or that is imported lawfully under the federal food, drug, and cosmetic act (21 United States Code section 301, et seq.) or pursuant to an announcement by the United States food and drug administration of the exercise of enforcement discretion for instances, including clinical research purposes, drug shortages, development of countermeasures against chemical, biological, radiological and nuclear terrorism agents, or pandemic influenza preparedness and response.
B. Drugs and devices that are to be processed, labeled or repacked at establishments other than those where originally processed or packed are exempt from any labeling or packaging requirements of this chapter, provided that such drugs and devices are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with board rules or under the federal act.
C. If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device or any combination of them, but also the extent to which the labeling fails to reveal facts material in the light of such representations, or material with respect to consequences which that may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling or under such conditions of use as are customary or usual.
D. A drug or device is not considered misbranded if it is either of the following:
1. Intended for the use in pharmaceutical compounding by a licensed pharmacist, physician, drug manufacturer or distributor or registered outsourcing facility in compliance with the requirements of this chapter 18 of this title and the federal food, drug, and cosmetic act (21 United States Code section 321a and 321b 321).
2. Mislabeled or incorrectly filled because of a filling error by a pharmacy or a pharmacist.
E. This section does not apply to any drug or device, whether or not approved by the United States food and drug administration, that is manufactured, packed or distributed for use in pharmaceutical compounding by a licensed pharmacist, physician, drug manufacturer or distributor or registered outsourcing facility in compliance with the requirements of this chapter 18 of this title, and the federal food, drug, and cosmetic act (21 United States Code section 321a and 321b 321).
F. For the purposes of this section, "dangerous drug" means any drug that is unsafe for self‑use in humans or animals and includes:
1. Any drug that bears the legend: "Caution: federal law prohibits dispensing without prescription", "Rx only", or words of similar import.
2. Any device that bears the statement: "Caution: federal law restricts this device to sale by or on the order of a ____", "Rx only", or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
3. Any other drug or device that by federal or state law can be lawfully dispensed only on prescription.
Sec. 18. Section 32-1982, Arizona Revised Statutes, is amended to read:
32-1982. Full‑service wholesale permittees; bonds; designated representatives; application
A. A full service full‑service wholesale permittee that engages in the wholesale distribution of prescription-only drugs into, within or from this state must maintain a bond and have a designated representative.
B. The designated representative of a full service full‑service wholesale permittee must:
1. Be at least twenty-one years of age.
2. Have been employed full time for at least three years in a pharmacy or with a full service wholesale permittee in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription‑only drugs.
3. 2. Be employed by the full service full‑service wholesale permittee in a managerial level position.
4. 3. Be actively involved in the daily operation of the wholesale distribution of prescription-only drugs.
5. 4. Be physically present at the full service full‑service wholesale permittee facility during regular business hours unless the absence of the designated representative is authorized.
6. 5. Serve as a designated representative for only one full service full‑service wholesale permittee.
7. 6. Not have any criminal convictions under any federal, state or local laws relating to wholesale or retail prescription-only drug distribution or distribution of controlled substances.
C. The board may require the applicant's designated representative to submit a full set of fingerprints to the board. The board shall submit the fingerprints to the department of public safety for the purpose of obtaining a state and federal criminal records check pursuant to section 41‑1750 and Public Law 92‑544. The department of public safety may exchange the fingerprint data with the federal bureau of investigation. The board may charge each applicant a fee determined by the department of public safety. The board shall forward this fee to the department of public safety.
D. The board shall require every full service full‑service wholesale permittee that is applying for an initial permit or renewal of a permit to submit a bond of at least one hundred thousand dollars $100,000 or other equivalent means of security acceptable to the board. The board may use this bond to secure payment of any fines or penalties that are imposed by the board and any fees or costs that are incurred by the board regarding the permit authorized by law and that the permittee fails to pay within thirty days after the fine, penalty or cost becomes final. The bond must cover all permits held by the permittee in this state.
E. The board may waive the bond requirement if the full service full‑service wholesale permittee has previously obtained a comparable surety bond or other equivalent means of security for the purpose of licensure in another state where the full service full‑service wholesale permittee possesses a valid license in good standing.
F. For the purposes of this article, a full service full‑service wholesale permittee does not include a hospital, chain pharmacy warehouse or third party third‑party logistics provider.
Sec. 19. Section 36-2602, Arizona Revised Statutes, is amended to read:
36-2602. Controlled substances prescription monitoring program; contracts; retention and maintenance of records
A. The board shall adopt rules to establish a controlled substances prescription monitoring program. The program shall:
1. Be operated, monitored and maintained by the board.
2. Be staffed by the board.
3. Include a computerized central database tracking system to track the prescribing, dispensing and consumption of schedule II, III, IV and V controlled substances that are dispensed by a medical practitioner or by a pharmacy that holds a valid license or permit issued pursuant to title 32. The database shall include data from the department of health services that identifies residents of this state who possess a registry identification card issued pursuant to chapter 28.1 of this title. The tracking system shall not interfere with the legal use of a controlled substance for the management of managing severe or intractable pain.
4. Assist law enforcement to identify illegal activity related to the prescribing, dispensing and consumption of consuming schedule II, III, IV and V controlled substances.
5. Provide information to patients, medical practitioners and pharmacists to help avoid the inappropriate use of schedule II, III, IV and V controlled substances.
6. Be designed to minimize inconvenience to patients, prescribing medical practitioners and pharmacies while effectuating the collection and storage of information.
B. The board may enter into private or public contracts, including intergovernmental agreements pursuant to title 11, chapter 7, article 3, to ensure the effective operation of the program. Each contractor must comply with the confidentiality requirements prescribed in this article and is subject to the criminal penalties prescribed in section 36‑2610.
C. The board shall maintain medical the following records information in the program pursuant to the standards prescribed in section 12‑2297 for the following periods of time:
1. A record of dispensing a controlled substance for seven years after the date the controlled substance was dispensed.
2. Affidavits for the purpose of an open investigation by law enforcement for two years.
3. Court orders requesting medical record information in the program for two years.
4. A patient's request of the patient's own prescription history for two years.
5. A prescriber report for two years.
Sec. 20. Section 36-2607, Arizona Revised Statutes, is amended to read:
36-2607. Disciplinary action
A. The registrant's professional licensing board may revoke or suspend a registrant's registration or may place the registrant on probation for any of the following:
1. The registrant's professional licensing board determines that the registration was obtained by fraudulent means.
2. The registrant's professional licensing board takes action to revoke, suspend or place on probation the registrant's license, permit or registration to prescribe or dispense drugs.
3. The registration was issued through error.
4. The registrant knowingly files with the board any application, renewal or other document that contains false or misleading information or the registrant gives false or misleading testimony to the board.
5. The registrant knowingly makes a false report or record required by this article.
6. A registrant that dispenses controlled substances does not resolve discrepancies on a prescription order with ten business days after being notified of the error.
7. A registrant that dispenses controlled substances does not resolve a failed attempt or missing transmission to the program with ten business days after the occurrence.
B. The board may deny a registration to an applicant for the grounds prescribed in subsection A of this section.
C. In addition to any other law, a licensed or permitted medical practitioner, pharmacist or pharmacy that fails to comply with the requirements of this article is subject to disciplinary action by the medical practitioner's, pharmacist's or pharmacy's professional licensing board. The board of pharmacy shall report to the appropriate professional licensing board the failure of a licensed or permitted medical practitioner, pharmacist or pharmacy to comply with the requirements of this article.
Sec. 21. Section 36-2608, Arizona Revised Statutes, is amended to read:
36-2608. Reporting requirements; waiver; exceptions
A. If a medical practitioner dispenses a controlled substance listed in section 36‑2513, 36‑2514, 36‑2515 or 36‑2516, or if a prescription for a controlled substance listed in any of those sections or naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration is dispensed by a pharmacy in this state, a health care facility in this state for outpatient use or a board‑permitted nonresident pharmacy for delivery to a person residing in this state, the medical practitioner, health care facility or pharmacy must report the following information as applicable and as prescribed by the board by rule:
1. The name, address, telephone number, prescription number and United States drug enforcement administration controlled substance registration number of the dispenser.
2. The name, address and date of birth of the person for whom the prescription is written.
3. The name, address, telephone number and United States drug enforcement administration controlled substance registration number of the prescribing medical practitioner.
4. The name, strength, quantity, dosage and national drug code number of the schedule II, III, IV or V controlled substance or naloxone hydrochloride or other opioid antagonist dispensed.
5. The date the prescription was dispensed.
6. The number of refills, if any, authorized by the medical practitioner.
B. Except as provided in subsection D of this section, a dispenser must use the September 28, 2011 version 4, release 2 standard implementation guide for prescription monitoring programs published by the American society for automation in pharmacy or any subsequent version or release of that guide to report the required information.
C. The board shall allow the reporter to transmit the required information by electronic data transfer if feasible or, if not feasible, on reporting forms as prescribed by the board. The reporter shall submit the required information once each day.
D. A dispenser who does not have an automated recordkeeping system capable of producing an electronic report in the established format may request a waiver from electronic reporting by submitting a written request to the board. The board shall grant the request if the dispenser agrees in writing to report the data by submitting a completed universal claim form as prescribed by the board by rule.
E. The board by rule may prescribe the prescription form to be used in prescribing a schedule II, III, IV or V controlled substance if the board determines that this would facilitate the reporting requirements of this section.
F. The reporting requirements of this section do not apply to the following:
1. A controlled substance that is administered directly to a patient.
2. A controlled substance that is dispensed by a medical practitioner at a health care facility licensed by this state if the quantity dispensed is limited to an amount adequate to treat the patient for a maximum of seventy‑two hours with not more than two seventy‑two‑hour cycles within any fifteen-day period.
3. A controlled substance sample.
4. The wholesale distribution of a schedule II, III, IV or V controlled substance. For the purposes of this paragraph, "wholesale distribution" has the same meaning prescribed in section 32‑1981.
5. A facility that is registered by the United States drug enforcement administration as a narcotic treatment program and that is subject to the recordkeeping provisions of 21 Code of Federal Regulations section 1304.24.
G. Naloxone hydrochloride or any other opioid antagonist may not be viewable in the patient utilization report.
