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- i - Conference Engrossed State of Arizona Senate Fifty-second Legislature Second Regular Session 2016 SENATE BILL 1112 AN ACT AMENDING SECTIONS 32-1901, 32-1970 AND 32-1974, ARIZONA REVISED STATUTES; AMENDING SECTION 36-449.03, ARIZONA REVISED STATUTES, AS AMENDED BY LAWS 2016, CHAPTER 75, SECTION 1; AMENDING SECTION 36-2153, ARIZONA REVISED STATUTES; RELATING TO THE ARIZONA STATE BOARD OF PHARMACY. (TEXT OF BILL BEGINS ON NEXT PAGE)

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Conference Engrossed State of Arizona Senate Fifty-second Legislature Second Regular Session 2016

SENATE BILL 1112

AN ACT

AMENDING SECTIONS 32-1901, 32-1970 AND 32-1974, ARIZONA REVISED STATUTES; AMENDING SECTION 36-449.03, ARIZONA REVISED STATUTES, AS AMENDED BY LAWS 2016, CHAPTER 75, SECTION 1; AMENDING SECTION 36-2153, ARIZONA REVISED STATUTES; RELATING TO THE ARIZONA STATE BOARD OF PHARMACY.

(TEXT OF BILL BEGINS ON NEXT PAGE)

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Be it enacted by the Legislature of the State of Arizona: 1 Section 1. Section 32-1901, Arizona Revised Statutes, is amended to 2

read: 3 32-1901. Definitions 4 In this chapter, unless the context otherwise requires: 5 1. "Administer" means the direct application of a controlled 6

substance, prescription-only drug, dangerous drug or narcotic drug, whether 7 by injection, inhalation, ingestion or any other means, to the body of a 8 patient or research subject by a practitioner or by the practitioner's 9 authorized agent or the patient or research subject at the direction of the 10 practitioner. 11

2. "Advertisement" means all representations disseminated in any 12 manner or by any means, other than by labeling, for the purpose of inducing, 13 or that are likely to induce, directly or indirectly, the purchase of drugs, 14 devices, poisons or hazardous substances. 15

3. "Advisory letter" means a nondisciplinary letter to notify a 16 licensee or permittee that either: 17

(a) While there is insufficient evidence to support disciplinary 18 action, the board believes that continuation of the activities that led to 19 the investigation may result in further board action against the licensee or 20 permittee. 21

(b) The violation is a minor or technical violation that is not of 22 sufficient merit to warrant disciplinary action. 23

(c) While the licensee or permittee has demonstrated substantial 24 compliance through rehabilitation, remediation or reeducation that has 25 mitigated the need for disciplinary action, the board believes that 26 repetition of the activities that led to the investigation may result in 27 further board action against the licensee or permittee. 28

4. "Antiseptic", if a drug is represented as such on its label, means 29 a representation that it is a germicide, except in the case of a drug 30 purporting to be, or represented as, an antiseptic for inhibitory use as a 31 wet dressing, ointment or dusting powder or other use that involves prolonged 32 contact with the body. 33

5. "Authorized officers of the law" means legally empowered peace 34 officers, compliance officers of the state board of pharmacy and agents of 35 the division of narcotics enforcement and criminal intelligence of the 36 department of public safety. 37

6. "Board" or "board of pharmacy" means the Arizona state board of 38 pharmacy. 39

7. "Color additive" means a material that either: 40 (a) Is any dye, pigment or other substance made by a process of 41

synthesis or similar artifice, or extracted, isolated or otherwise derived, 42 with or without intermediate or final change of identity, from any vegetable, 43 animal, mineral or other source. 44

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(b) If added or applied to a drug, or to the human body or any part of 1 the human body, is capable of imparting color, except that color additive 2 does not include any material that has been or may be exempted under the 3 federal act. Color includes black, white and intermediate grays. 4

8. "Compounding" means the preparation, mixing, assembling, packaging 5 or labeling of a drug by a pharmacist or an intern or pharmacy technician 6 under the pharmacist's supervision, for the purpose of dispensing to a 7 patient based on a valid prescription order. Compounding includes the 8 preparation of drugs in anticipation of prescription orders prepared on 9 routine, regularly observed prescribing patterns and the preparation of drugs 10 as an incident to research, teaching or chemical analysis or for 11 administration by a medical practitioner to the medical practitioner's 12 patient and not for sale or dispensing. Compounding does not include the 13 preparation of commercially available products from bulk compounds or the 14 preparation of drugs for sale to pharmacies, practitioners or entities for 15 the purpose of dispensing or distribution. 16

9. "Compressed medical gas distributor" means a person who holds a 17 current permit issued by the board to distribute compressed medical gases 18 pursuant to a compressed medical gas order to compressed medical gas 19 suppliers and other entities that are registered, licensed or permitted to 20 use, administer or distribute compressed medical gases. 21

10. "Compressed medical gas order" means an order for compressed 22 medical gases that is issued by a medical practitioner. 23

11. "Compressed medical gas supplier" means a person who holds a 24 current permit issued by the board to supply compressed medical gases 25 pursuant to a compressed medical gas order and only to the consumer or the 26 patient. 27

12. "Compressed medical gases" means gases and liquid oxygen that a 28 compressed medical gas distributor or manufacturer has labeled in compliance 29 with federal law. 30

13. "Controlled substance" means a drug, substance or immediate 31 precursor THAT IS identified, defined or listed in title 36, chapter 27, 32 article 2. 33

14. "Corrosive" means any substance that when it comes in contact with 34 living tissue will cause destruction of tissue by chemical action. 35

15. "Counterfeit drug" means a drug that, or the container or labeling 36 of which, without authorization, bears the trademark, trade name or other 37 identifying mark, imprint, number or device, or any likeness of these, of a 38 manufacturer, distributor or dispenser other than the person who in fact 39 manufactured, distributed or dispensed that drug. 40

16. "Dangerous drug" has the same meaning prescribed in section 41 13-3401. 42

17. "Decree of censure" means an official action that is taken by the 43 board and that may include a requirement for restitution of fees to a patient 44 or consumer. 45

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18. "Deliver" or "delivery" means the actual, constructive or attempted 1 transfer from one person to another whether or not there is an agency 2 relationship. 3

19. "Deputy director" means a pharmacist who is employed by the board 4 and selected by the executive director to perform duties as prescribed by the 5 executive director. 6

20. "Device", except as used in paragraph 15 of this section, section 7 32-1965, paragraph 4 and section 32-1967, subsection A, paragraph 15 and 8 subsection C, means instruments, apparatus and contrivances, including their 9 components, parts and accessories, including all such items under the federal 10 act, intended either: 11

(a) For use in the diagnosis, cure, mitigation, treatment or 12 prevention of disease in the human body or other animals. 13

(b) To affect the structure or any function of the human body or other 14 animals. 15

21. "Direct supervision of a pharmacist" means the pharmacist is 16 present. If relating to the sale of certain items, direct supervision of a 17 pharmacist means that a pharmacist determines the legitimacy or advisability 18 of a proposed purchase of those items. 19

22. "Director" means the director of the division of narcotics 20 enforcement and criminal investigation of the department of public safety. 21

23. "Dispense" means to deliver to an ultimate user or research subject 22 by or pursuant to the lawful order of a practitioner, including the 23 prescribing, administering, packaging, labeling or compounding necessary to 24 prepare for that delivery. 25

24. "Dispenser" means a practitioner who dispenses. 26 25. "Distribute" means to deliver, other than by administering or 27

dispensing. 28 26. "Distributor" means a person who distributes. 29 27. "Drug" means: 30 (a) Articles recognized, or for which standards or specifications are 31

prescribed, in the official compendium. 32 (b) Articles intended for use in the diagnosis, cure, mitigation, 33

treatment or prevention of disease in the human body or other animals. 34 (c) Articles other than food intended to affect the structure or any 35

function of the human body or other animals. 36 (d) Articles intended for use as a component of any articles specified 37

in subdivision (a), (b) or (c) of this paragraph but does not include devices 38 or their components, parts or accessories. 39

28. "Drug enforcement administration" means the drug enforcement 40 administration of the United States department of justice or its successor 41 agency. 42

29. "Drug or device manufacturing" means the production, preparation, 43 propagation or processing of a drug or device, either directly or indirectly, 44 by extraction from substances of natural origin or independently by means of 45

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chemical synthesis and includes any packaging or repackaging of substances or 1 labeling or relabeling of its container and the promotion and marketing of 2 the same. Drug or device manufacturing does not include compounding. 3

30. "Economic poison" means any substance that alone, in chemical 4 combination or in formulation with one or more other substances is a 5 pesticide within the meaning of the laws of this state or the federal 6 insecticide, fungicide and rodenticide act and that is used in the 7 production, storage or transportation of raw agricultural commodities. 8

31. "Established name", with respect to a drug or ingredient of a drug, 9 means any of the following: 10

(a) The applicable official name. 11 (b) If there is no such name and the drug or ingredient is an article 12

recognized in an official compendium, the official title in an official 13 compendium. 14

(c) If neither subdivision (a) nor (b) of this paragraph applies, the 15 common or usual name of such drug. 16

32. "Executive director" means the executive director of the board of 17 pharmacy. 18

33. "Federal act" means the federal laws and regulations that pertain 19 to drugs, devices, poisons and hazardous substances and that are official at 20 the time any drug, device, poison or hazardous substance is affected by this 21 chapter. 22

34. "Full service wholesale permittee" means a permittee who may 23 distribute prescription-only drugs and devices, controlled substances and 24 over-the-counter drugs and devices to pharmacies or other legal outlets from 25 a place devoted in whole or in part to wholesaling these items. 26

35. "Graduate intern" means a person who has graduated from a college, 27 school or program of pharmacy approved by the board and who meets the 28 qualifications and experience for a pharmacy intern as provided in section 29 32-1923. 30

36. "Highly toxic" means any substance that falls within any of the 31 following categories: 32

(a) Produces death within fourteen days in half or more than half of a 33 group of ten or more laboratory white rats each weighing between two hundred 34 and three hundred grams, at a single dose of fifty milligrams or less per 35 kilogram of body weight, when orally administered. 36

(b) Produces death within fourteen days in half or more than half of a 37 group of ten or more laboratory white rats each weighing between two hundred 38 and three hundred grams, if inhaled continuously for a period of one hour or 39 less at an atmospheric concentration of two hundred parts per million by 40 volume or less of gas or vapor or two milligrams per liter by volume or less 41 of mist or dust, provided the concentration is likely to be encountered by 42 humans if the substance is used in any reasonably foreseeable manner. 43

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(c) Produces death within fourteen days in half or more than half of a 1 group of ten or more rabbits tested in a dosage of two hundred milligrams or 2 less per kilogram of body weight, if administered by continuous contact with 3 the bare skin for twenty-four hours or less. 4 If the board finds that available data on human experience with any substance 5 indicate results different from those obtained on animals in the dosages or 6 concentrations prescribed in this paragraph, the human data shall take 7 precedence. 8

37. "Hospital" means any institution for the care and treatment of the 9 sick and injured that is approved and licensed as a hospital by the 10 department of health services. 11

38. "Intern" means a pharmacy intern and a graduate intern. 12 39. "Internship" means the practical, experiential, hands-on training 13

of a pharmacy intern under the supervision of a preceptor. 14 40. "Irritant" means any substance, other than a corrosive, that on 15

immediate, prolonged or repeated contact with normal living tissue will 16 induce a local inflammatory reaction. 17

41. "Jurisprudence examination" means a board approved BOARD-APPROVED 18 pharmacy law examination that is written and administered in cooperation with 19 the national association of boards of pharmacy or another board approved 20 BOARD-APPROVED pharmacy law examination. 21

42. "Label" means a display of written, printed or graphic matter on 22 the immediate container of any article that, unless easily legible through 23 the outside wrapper or container, also appears on the outside wrapper or 24 container of the article's retail package. For the purposes of this 25 paragraph, the immediate container does not include package liners. 26

43. "Labeling" means all labels and other written, printed or graphic 27 matter either: 28

(a) On any article or any of its containers or wrappers. 29 (b) Accompanying that article. 30 44. "Letter of reprimand" means a disciplinary letter that is a public 31

document issued by the board and that informs a licensee or permittee that 32 the licensee's or permittee's conduct violates state or federal law and may 33 require the board to monitor the licensee or permittee. 34

45. "Limited service pharmacy" means a pharmacy that is approved by the 35 board to practice a limited segment of pharmacy as indicated by the permit 36 issued by the board. 37

46. "Manufacture" or "manufacturer" means every person who prepares, 38 derives, produces, compounds, processes, packages or repackages or labels any 39 drug in a place, other than a pharmacy, devoted to manufacturing the drug. 40

47. "Marijuana" has the same meaning prescribed in section 13-3401. 41 48. "Medical practitioner" means any medical doctor, doctor of 42

osteopathy, dentist, podiatrist, veterinarian or other person WHO IS licensed 43 and authorized by law to use and prescribe drugs and devices for the 44 treatment of sick and injured human beings or animals or for the diagnosis or 45

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prevention of sickness in human beings or animals in this state or any state, 1 territory or district of the United States. 2

49. "Medication order" means a written or verbal order from a medical 3 practitioner or that person's authorized agent to administer a drug or 4 device. 5

50. "Narcotic drug" has the same meaning prescribed in section 13-3401. 6 51. "New drug" means either: 7 (a) Any drug the composition of which is such that the drug is not 8

generally recognized among experts qualified by scientific training and 9 experience to evaluate the safety and effectiveness of drugs as safe and 10 effective for use under the conditions prescribed, recommended or suggested 11 in the labeling. 12

(b) Any drug the composition of which is such that the drug, as a 13 result of investigations to determine its safety and effectiveness for use 14 under such conditions, has become so recognized, but that has not, other than 15 in the investigations, been used to a material extent or for a material time 16 under those conditions. 17

52. "Nonprescription drug" or "over-the-counter drug" means any 18 nonnarcotic medicine or drug that may be sold without a prescription and is 19 prepackaged and labeled for use by the consumer in accordance with the 20 requirements of the laws of this state and federal law. Nonprescription drug 21 does not include: 22

(a) A drug that is primarily advertised and promoted professionally to 23 medical practitioners and pharmacists by manufacturers or primary 24 distributors. 25

(b) A controlled substance. 26 (c) A drug that is required to bear a label that states "Rx only." 27 (d) A drug THAT IS intended for human use by hypodermic injection. 28 53. "Nonprescription drug wholesale permittee" means a permittee who 29

may distribute only over-the-counter drugs and devices to pharmacies or other 30 lawful outlets from a place devoted in whole or in part to wholesaling these 31 items. 32

54. "Notice" means personal service or the mailing of a copy of the 33 notice by certified mail addressed either to the person at the person's 34 latest address of record in the board office or to the person's attorney. 35

55. "Official compendium" means the latest revision of the United 36 States pharmacopeia and the national formulary or any current supplement. 37

56. "Other jurisdiction" means one of the other forty-nine states, the 38 District of Columbia, the Commonwealth of Puerto Rico or a territory of the 39 United States of America. 40

57. "Package" means a receptacle defined or described in the United 41 States pharmacopeia and the national formulary as adopted by the board. 42

58. "Packaging" means the act or process of placing a drug item or 43 device in a container for the purpose or intent of dispensing or distributing 44 the item or device to another. 45

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59. "Person" means an individual, partnership, corporation and 1 association, and their duly authorized agents. 2

60. "Pharmaceutical care" means the provision of drug therapy and other 3 pharmaceutical patient care services. 4

61. "Pharmacist" means an individual WHO IS currently licensed by the 5 board to practice the profession of pharmacy in this state. 6

62. "Pharmacist in charge" means the pharmacist who is responsible to 7 the board for a licensed establishment's compliance with the laws and 8 administrative rules of this state and of the federal government pertaining 9 to the practice of pharmacy, the manufacturing of drugs and the distribution 10 of drugs and devices. 11

63. "Pharmacist licensure examination" means a board approved 12 BOARD-APPROVED examination that is written and administered in cooperation 13 with the national association of boards of pharmacy or any other board 14 approved BOARD-APPROVED pharmacist licensure examination. 15

64. "Pharmacy" means any place: 16 (a) Where drugs, devices, poisons or related hazardous substances are 17

offered for sale at retail. 18 (b) In which the profession of pharmacy is practiced or where 19

prescription orders are compounded and dispensed. 20 (c) That has displayed on it or in it the words "pharmacist," 21

"pharmaceutical chemist," "apothecary," "druggist," "pharmacy," "drugstore," 22 "drugs" or "drug sundries" or any of these words or combinations of these 23 words, or words of similar import either in English or any other language, or 24 that is advertised by any sign containing any of these words. 25

(d) Where the characteristic symbols of pharmacy or the characteristic 26 prescription sign "Rx" is exhibited. 27

(e) Or a portion of any building or structure that is leased, used or 28 controlled by the permittee to conduct the business authorized by the board 29 at the address for which the permit was issued and that is enclosed and 30 secured when a pharmacist is not in attendance. 31

65. "Pharmacy intern" means a person who has all of the qualifications 32 and experience prescribed in section 32-1923. 33

66. "Pharmacy technician" means a person who is licensed pursuant to 34 this chapter. 35

67. "Pharmacy technician trainee" means a person who is licensed 36 pursuant to this chapter. 37

68. "Poison" or "hazardous substance" includes, but is not limited to, 38 any of the following if intended and suitable for household use or use by 39 children: 40

(a) Any substance that, according to standard works on medicine, 41 pharmacology, pharmacognosy or toxicology, if applied to, introduced into or 42 developed within the body in relatively small quantities by its inherent 43 action uniformly produces serious bodily injury, disease or death. 44

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(b) A toxic substance. 1 (c) A highly toxic substance. 2 (d) A corrosive substance. 3 (e) An irritant. 4 (f) A strong sensitizer. 5 (g) A mixture of any of the substances described in this paragraph, if 6

the substance or mixture of substances may cause substantial personal injury 7 or substantial illness during or as a proximate result of any customary or 8 reasonably foreseeable handling or use, including reasonably foreseeable 9 ingestion by children. 10

(h) A substance THAT IS designated by the board to be a poison or 11 hazardous substance. This subdivision does not apply to radioactive 12 substances, economic poisons subject to the federal insecticide, fungicide 13 and rodenticide act or the state pesticide act, foods, drugs and cosmetics 14 subject to state laws or the federal act or substances intended for use as 15 fuels when stored in containers and used in the heating, cooking or 16 refrigeration system of a house. This subdivision applies to any substance 17 or article that is not itself an economic poison within the meaning of the 18 federal insecticide, fungicide and rodenticide act or the state pesticide 19 act, but that is a poison or hazardous substance within the meaning of this 20 paragraph by reason of bearing or containing an economic poison or hazardous 21 substance. 22

69. "Practice of pharmacy": 23 (a) Means furnishing the following health care services as a medical 24

professional: 25 (a) (i) Interpreting, evaluating and dispensing prescription orders 26

in the patient's best interests. 27 (b) (ii) Compounding drugs pursuant to or in anticipation of a 28

prescription order. 29 (c) (iii) Labeling of drugs and devices in compliance with state and 30

federal requirements. 31 (d) (iv) Participating in drug selection and drug utilization 32

reviews, drug administration, drug or drug-related research and drug therapy 33 monitoring or management. 34

(e) (v) Providing patient counseling necessary to provide 35 pharmaceutical care. 36

(f) (vi) Properly and safely storing drugs and devices in 37 anticipation of dispensing. 38

(g) (vii) Maintaining required records of drugs and devices. 39 (h) (viii) Offering or performing of acts, services, operations or 40

transactions necessary in the conduct, operation, management and control of a 41 pharmacy. 42

(i) (ix) Implementing INITIATING, monitoring and modifying drug 43 therapy pursuant to a protocol-based drug therapy agreement with a provider 44 as outlined in section 32-1970. 45

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(j) (x) Initiating and administering immunizations or vaccines 1 pursuant to section 32-1974. 2

(b) DOES NOT INCLUDE INITIATING A PRESCRIPTION ORDER FOR ANY 3 MEDICATION, DRUG OR OTHER SUBSTANCE USED TO INDUCE OR CAUSE A MEDICATION 4 ABORTION AS DEFINED IN SECTION 36-2151. 5

70. "Practitioner" means any physician, dentist, veterinarian, 6 scientific investigator or other person who is licensed, registered or 7 otherwise permitted to distribute, dispense, conduct research with respect to 8 or administer a controlled substance in the course of professional practice 9 or research in this state, or any pharmacy, hospital or other institution 10 that is licensed, registered or otherwise permitted to distribute, dispense, 11 conduct research with respect to or administer a controlled substance in the 12 course of professional practice or research in this state. 13

71. "Preceptor" means a pharmacist who is serving as the practical 14 instructor of an intern and complies with section 32-1923. 15

72. "Precursor chemical" means a substance that is: 16 (a) The principal compound that is commonly used or that is produced 17

primarily for use and that is an immediate chemical intermediary used or 18 likely to be used in the manufacture of a controlled substance, the control 19 of which is necessary to prevent, curtail or limit manufacture. 20

(b) Listed in section 13-3401, paragraph 26 or 27. 21 73. "Prescription" means either a prescription order or a prescription 22

medication. 23 74. "Prescription medication" means any drug, including label and 24

container according to context, that is dispensed pursuant to a prescription 25 order. 26

75. "Prescription-only device" includes: 27 (a) Any device that is limited by the federal act to use under the 28

supervision of a medical practitioner. 29 (b) Any device required by the federal act to bear on its label 30

essentially the legend "Rx only". 31 76. "Prescription-only drug" does not include a controlled substance 32

but does include: 33 (a) Any drug that because of its toxicity or other potentiality for 34

harmful effect, the method of its use, or the collateral measures necessary 35 to its use is not generally recognized among experts, qualified by scientific 36 training and experience to evaluate its safety and efficacy, as safe for use 37 except by or under the supervision of a medical practitioner. 38

(b) Any drug that is limited by an approved new drug application under 39 the federal act or section 32-1962 to use under the supervision of a medical 40 practitioner. 41

(c) Every potentially harmful drug, the labeling of which does not 42 bear or contain full and adequate directions for use by the consumer. 43

(d) Any drug, other than a controlled substance, required by the 44 federal act to bear on its label the legend "Rx only". 45

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77. "Prescription order" means any of the following: 1 (a) An order to a pharmacist for drugs or devices issued and signed by 2

a duly licensed medical practitioner in the authorized course of the 3 practitioner's professional practice. 4

(b) An order transmitted to a pharmacist through word of mouth, 5 telephone or other means of communication directed by that medical 6 practitioner. Prescription orders received by word of mouth, telephone or 7 other means of communication shall be maintained by the pharmacist pursuant 8 to section 32-1964, and the record so made by the pharmacist constitutes the 9 original prescription order to be dispensed by the pharmacist. This 10 paragraph does not alter or affect laws of this state or any federal act 11 requiring a written prescription order. 12

(c) An order initiated by a pharmacist pursuant to a protocol-based 13 drug therapy agreement with a provider as outlined in section 32-1970, or 14 immunizations or vaccines administered by a pharmacist pursuant to section 15 32-1974. 16

78. "Professionally incompetent" means: 17 (a) Incompetence based on a variety of factors, including a lack of 18

sufficient pharmaceutical knowledge or skills or experience to a degree 19 likely to endanger the health of patients. 20

(b) When considered with other indications of professional 21 incompetence, a pharmacist, pharmacy intern or graduate intern who fails to 22 obtain a passing score on a board approved BOARD-APPROVED pharmacist 23 licensure examination or a pharmacy technician or pharmacy technician trainee 24 who fails to obtain a passing score on a board approved BOARD-APPROVED 25 pharmacy technician licensure examination. 26

79. "Radioactive substance" means a substance that emits ionizing 27 radiation. 28

80. "Safely engage in employment duties" means that a permittee or the 29 permittee's employee is able to safely engage in employment duties related to 30 the manufacture, sale, distribution or dispensing of drugs, devices, poisons, 31 hazardous substances, controlled substances or precursor chemicals. 32

81. "Symbol" means the characteristic symbols that have historically 33 identified pharmacy, including "show globes", AND "mortar and pestle," and 34 the sign "Rx". 35

82. "Toxic substance" means a substance, other than a radioactive 36 substance, that has the capacity to produce injury or illness in humans 37 through ingestion, inhalation or absorption through any body surface. 38

83. "Ultimate user" means a person who lawfully possesses a drug or 39 controlled substance for that person's own use, for the use of a member of 40 that person's household or for administering to an animal owned by that 41 person or by a member of that person's household. 42

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Sec. 2. Section 32-1970, Arizona Revised Statutes, is amended to read: 1 32-1970. Initiating, monitoring and modifying drug therapy and 2

use; conditions; definitions 3 A. A pharmacist licensed pursuant to this chapter may implement 4

INITIATE, monitor and modify drug therapy and use only under the following 5 circumstances: 6

1. The patient's drug therapy and use are pursuant to a provider. 7 2. The pharmacist complies with rules adopted by the state board of 8

pharmacy. 9 3. The pharmacist follows the written drug therapy management 10

protocols prescribed by the provider who made the diagnosis and implements 11 INITIATES, monitors or modifies a person's drug therapy and use only pursuant 12 to those protocols. Each protocol developed pursuant to the drug therapy 13 agreement shall contain detailed directions concerning the actions that the 14 pharmacist may perform for that patient. The protocol shall specify, at a 15 minimum, the specific drug or drugs to be managed by the pharmacist, the 16 conditions and events for which the pharmacist must notify the provider and 17 the laboratory tests that may be ordered. A provider who enters into a 18 protocol-based drug therapy agreement must have a legitimate provider-patient 19 relationship. 20

B. A licensee who violates this section commits an act of 21 unprofessional conduct. 22

C. A pharmacist is responsible for the pharmacist's negligent acts 23 that are the result of the pharmacist's change of medication or that relate 24 to patient drug usage pursuant to drug therapy management protocols. This 25 subsection does not limit a provider's liability for negligent acts that are 26 not related to a pharmacist's change of medication pursuant to the protocols. 27

D. For the purposes of this section: 28 1. "Implement INITIATE, monitor and modify" means that a pharmacist 29

may perform specific acts as authorized by a provider pursuant to written 30 guidelines and protocols. This does not include the selection of drug 31 products not prescribed by the provider unless selection of the specific drug 32 product is authorized by the written guidelines and protocols. 33

2. "Protocol" means a provider's written order, written standing 34 medical order or other written order of protocol as defined by rules adopted 35 by the Arizona medical board, and the ARIZONA board of osteopathic examiners 36 in medicine and surgery AND THE ARIZONA STATE BOARD OF NURSING and that are 37 IS patient, provider and pharmacist specific for prescriptions or orders 38 given by the provider authorizing the written protocol. 39

3. "Provider" means a physician who is licensed pursuant to chapter 13 40 or 17 of this title or a registered nurse practitioner who is licensed 41 pursuant to chapter 15 of this title and who acts as a primary care 42 practitioner. 43

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Sec. 3. Section 32-1974, Arizona Revised Statutes, is amended to read: 1 32-1974. Pharmacists; administration of immunizations, vaccines 2

and emergency medications; certification; reporting 3 requirements; advisory committee; definitions 4

A. Except as prescribed pursuant to subsection I of this section, a 5 pharmacist who is licensed pursuant to this chapter and who meets the 6 requirements of this section may administer the following to adults without a 7 prescription order pursuant to rules and protocols adopted by the board 8 pursuant to this section: 9

1. Immunizations or vaccines listed in RECOMMENDED FOR ADULTS BY the 10 United States centers for disease control and prevention's recommended adult 11 immunization schedule PREVENTION. 12

2. Immunizations or vaccines recommended by the United States centers 13 for disease control and prevention's health information for international 14 travel. 15

B. A pharmacist who is licensed pursuant to this chapter and who meets 16 the requirements of this section may administer the following to a person who 17 is at least six years of age but under eighteen years of age MINORS without a 18 prescription order pursuant to rules and protocols adopted by the board 19 pursuant to this section: 20

1. INFLUENZA immunizations or vaccines for influenza TO A PERSON WHO 21 IS AT LEAST THREE YEARS OF AGE. 22

2. Immunizations or vaccines in response to a public health emergency 23 declared by the governor pursuant to section 36-787. 24

2. BOOSTER DOSES FOR THE PRIMARY ADOLESCENT SERIES AS RECOMMENDED BY 25 THE UNITED STATES CENTERS FOR DISEASE CONTROL AND PREVENTION. 26

3. IMMUNIZATIONS OR VACCINES RECOMMENDED BY THE UNITED STATES CENTERS 27 FOR DISEASE CONTROL AND PREVENTION TO A PERSON WHO IS AT LEAST THIRTEEN YEARS 28 OF AGE. 29

C. Pursuant to a prescription order EXCEPT AS PRESCRIBED IN SUBSECTION 30 B OF THIS SECTION, a pharmacist who is licensed pursuant to this chapter and 31 who meets the requirements of this section may administer immunizations and 32 vaccines, INCLUDING THE FIRST DOSE FOR THE PRIMARY ADOLESCENT SERIES, to a 33 person who is at least six years of age but under eighteen THIRTEEN years of 34 age ONLY WITH A PRESCRIPTION ORDER AND pursuant to rules and protocols 35 adopted by the board pursuant to this section. 36

D. A pharmacist who wishes to administer immunizations and vaccines 37 pursuant to this section must be certified to do so by the board. The board 38 shall issue a certificate to a pharmacist who meets board requirements for 39 certification as prescribed by the board by rule. 40

E. A pharmacist who is certified to administer immunizations and 41 vaccines pursuant to this section may administer WITHOUT A PRESCRIPTION 42 ORDER: 43

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1. Emergency medication to manage an acute allergic reaction to an 1 immunization, or vaccine OR MEDICATION IN ACCORDANCE WITH THE UNITED STATES 2 CENTERS FOR DISEASE CONTROL AND PREVENTION IMMUNIZATION GUIDELINES. 3

2. IMMUNIZATIONS OR VACCINES TO ANY PERSON REGARDLESS OF AGE DURING A 4 PUBLIC HEALTH EMERGENCY RESPONSE OF THIS STATE PURSUANT TO SECTION 36-787. 5

F. A pharmacist who administers an immunization, vaccine or emergency 6 medication pursuant to this section must: 7

1. Report the administration to the person's IDENTIFIED primary care 8 provider or physician, if the primary care provider or physician is 9 available, within forty-eight hours after administering the immunization, 10 vaccine or emergency medication and as prescribed by the board by rule. 11 FAILURE TO REPORT THE ADMINISTRATION OF AN IMMUNIZATION, VACCINE OR EMERGENCY 12 MEDICATION PURSUANT TO THIS SECTION IS A VIOLATION OF SECTION 32-1901.01, 13 SUBSECTION B, PARAGRAPH 2. THE PHARMACIST SHALL MAKE A REASONABLE EFFORT TO 14 IDENTIFY THE PERSON'S PRIMARY CARE PROVIDER OR PHYSICIAN BY ONE OR MORE OF 15 THE FOLLOWING METHODS: 16

(a) CHECKING ANY ADULT IMMUNIZATION INFORMATION SYSTEM OR VACCINE 17 REGISTRY ESTABLISHED BY THE DEPARTMENT OF HEALTH SERVICES. 18

(b) CHECKING PHARMACY RECORDS. 19 (c) REQUESTING THE INFORMATION FROM THE PERSON OR, IN THE CASE OF A 20

MINOR, THE PERSON'S PARENT OR GUARDIAN. 21 2. Report information to any adult immunization information system or 22

vaccine registry established by the department of health services. 23 3. Maintain a record of the immunization pursuant to title 12, chapter 24

13, article 7.1 and as prescribed by the board by rule. 25 4. REPORT TO THE PERSON'S IDENTIFIED PRIMARY CARE PROVIDER OR 26

PHYSICIAN, WITHIN TWENTY-FOUR HOURS OF OCCURRENCE, ANY ADVERSE REACTION THAT 27 IS REPORTED TO OR WITNESSED BY THE PHARMACIST AND THAT IS LISTED BY THE 28 VACCINE MANUFACTURER AS A CONTRAINDICATION TO FURTHER DOSES OF THE VACCINE. 29

4. 5. Participate in any federal vaccine adverse event reporting 30 system or successor database. 31

G. This section does not establish a cause of action against a 32 patient's primary care provider OR PHYSICIAN for any adverse reaction, 33 complication or negative outcome arising from the administration of any 34 immunization, vaccine or emergency medication by a pharmacist to a THE 35 patient pursuant to this section if it is administered without a prescription 36 ORDER written by the patient's primary care provider OR PHYSICIAN. 37

H. The board shall adopt rules for the administration of vaccines or 38 immunizations pursuant to this section regarding: 39

1. Protocols that are based on protocols approved by the United States 40 centers for disease control and prevention and any advisory committee 41 appointed by the board for the purpose of recommending protocols. 42

2. Record keeping RECORDKEEPING and reporting requirements. 43 3. Requirements and qualifications for pharmacist certification 44

pursuant to this section. 45

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4. Vaccine information and educational materials for those requesting 1 vaccines and immunizations. 2

5. The administration of emergency medication pursuant to this 3 section. 4

I. The department of health services, by rule, shall establish and 5 maintain a list of immunizations or vaccines that may be administered to 6 adults by a pharmacist only pursuant to a prescription order. In adopting 7 and maintaining this list, the department is exempt from the rule making 8 RULEMAKING requirements of title 41, chapter 6. The department shall adopt 9 its initial rules within six months after receipt of the recommendations of 10 the advisory committee appointed by the board and shall hold one public 11 hearing before implementing the rules and any amendments to the rules. The 12 list shall include those immunizations or vaccines listed in the United 13 States centers for disease control and prevention's recommended adult 14 immunization schedule or recommended by the United States centers for disease 15 control and prevention's health information for international travel that 16 have adverse reactions that could cause significant harm to a patient's 17 health. A pharmacist may not administer immunizations or vaccines without a 18 prescription order pursuant to this section before the department has 19 established the list pursuant to this subsection. The board may not 20 authorize a pharmacist to administer new immunizations or vaccines without a 21 prescription order pursuant to this section until the department reviews the 22 new immunizations and vaccines to determine if they should be added to the 23 list established pursuant to this subsection. 24

J. The board may appoint an advisory committee to assist the board in 25 adopting and amending rules and developing protocols relating to the 26 administration of immunizations, vaccines and emergency medications and 27 certification requirements. 28

K. A pharmacy intern who is certified by the board to administer 29 immunizations and vaccines pursuant to this section may do so only in the 30 presence and under the immediate personal supervision of a pharmacist WHO IS 31 certified as prescribed in this section. 32

L. This section does not prevent a pharmacist who administers an 33 immunization or vaccine from participating in the federal vaccines for 34 children program. 35

M. A pharmacist may not administer an immunization or vaccine to a 36 minor pursuant to subsection B or C of this section without the consent of 37 the minor's parent or guardian. 38

N. For the purposes of this section: , 39 1. "Emergency medication" means emergency epinephrine and 40

diphenhydramine AND ANTIHISTAMINES IN ACCORDANCE WITH THE UNITED STATES 41 CENTERS FOR DISEASE CONTROL AND PREVENTION IMMUNIZATION GUIDELINES. 42

2. "PRIMARY ADOLESCENT SERIES" MEANS THOSE IMMUNIZATIONS OR VACCINES 43 RECOMMENDED BY THE UNITED STATES CENTERS FOR DISEASE CONTROL AND PREVENTION 44 FOR CHILDREN STARTING AT AGE ELEVEN OR TWELVE. 45

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Sec. 4. Section 36-449.03, Arizona Revised Statutes, as amended by 1 Laws 2016, chapter 75, section 1, is amended to read: 2

36-449.03. Abortion clinics; rules; civil penalties 3 A. The director shall adopt rules for an abortion clinic's physical 4

facilities. At a minimum these rules shall prescribe standards for: 5 1. Adequate private space that is specifically designated for 6

interviewing, counseling and medical evaluations. 7 2. Dressing rooms for staff and patients. 8 3. Appropriate lavatory areas. 9 4. Areas for preprocedure hand washing. 10 5. Private procedure rooms. 11 6. Adequate lighting and ventilation for abortion procedures. 12 7. Surgical or gynecologic examination tables and other fixed 13

equipment. 14 8. Postprocedure recovery rooms that are supervised, staffed and 15

equipped to meet the patients' needs. 16 9. Emergency exits to accommodate a stretcher or gurney. 17 10. Areas for cleaning and sterilizing instruments. 18 11. Adequate areas for the secure storage of medical records and 19

necessary equipment and supplies. 20 12. The display in the abortion clinic, in a place that is conspicuous 21

to all patients, of the clinic's current license issued by the department. 22 B. The director shall adopt rules to prescribe abortion clinic 23

supplies and equipment standards, including supplies and equipment that are 24 required to be immediately available for use or in an emergency. At a 25 minimum these rules shall: 26

1. Prescribe required equipment and supplies, including medications, 27 required for the conduct, in an appropriate fashion, of any abortion 28 procedure that the medical staff of the clinic anticipates performing and for 29 monitoring the progress of each patient throughout the procedure and recovery 30 period. 31

2. Require that the number or amount of equipment and supplies at the 32 clinic is adequate at all times to assure sufficient quantities of clean and 33 sterilized durable equipment and supplies to meet the needs of each patient. 34

3. Prescribe required equipment, supplies and medications that shall 35 be available and ready for immediate use in an emergency and requirements for 36 written protocols and procedures to be followed by staff in an emergency, 37 such as the loss of electrical power. 38

4. Prescribe required equipment and supplies for required laboratory 39 tests and requirements for protocols to calibrate and maintain laboratory 40 equipment at the abortion clinic or operated by clinic staff. 41

5. Require ultrasound equipment. 42 6. Require that all equipment is safe for the patient and the staff, 43

meets applicable federal standards and is checked annually to ensure safety 44 and appropriate calibration. 45

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C. The director shall adopt rules relating to abortion clinic 1 personnel. At a minimum these rules shall require that: 2

1. The abortion clinic designate a medical director of the abortion 3 clinic who is licensed pursuant to title 32, chapter 13, 17 or 29. 4

2. Physicians performing abortions are licensed pursuant to title 32, 5 chapter 13 or 17, demonstrate competence in the procedure involved and are 6 acceptable to the medical director of the abortion clinic. 7

3. A physician is available: 8 (a) For a surgical abortion who has admitting privileges at a health 9

care institution that is classified by the director as a hospital pursuant to 10 section 36-405, subsection B and that is within thirty miles of the abortion 11 clinic. 12

(b) For a medication abortion who has admitting privileges at a health 13 care institution that is classified by the director as a hospital pursuant to 14 section 36-405, subsection B. 15

4. If a physician is not present, a registered nurse, nurse 16 practitioner, licensed practical nurse or physician assistant is present and 17 remains at the clinic when abortions are performed to provide postoperative 18 monitoring and care, or monitoring and care after inducing a medication 19 abortion, until each patient who had an abortion that day is discharged. 20

5. Surgical assistants receive training in counseling, patient 21 advocacy and the specific responsibilities of the services the surgical 22 assistants provide. 23

6. Volunteers receive training in the specific responsibilities of the 24 services the volunteers provide, including counseling and patient advocacy as 25 provided in the rules adopted by the director for different types of 26 volunteers based on their responsibilities. 27

D. The director shall adopt rules relating to the medical screening 28 and evaluation of each abortion clinic patient. At a minimum these rules 29 shall require: 30

1. A medical history, including the following: 31 (a) Reported allergies to medications, antiseptic solutions or latex. 32 (b) Obstetric and gynecologic history. 33 (c) Past surgeries. 34 2. A physical examination, including a bimanual examination estimating 35

uterine size and palpation of the adnexa. 36 3. The appropriate laboratory tests, including: 37 (a) Urine or blood tests for pregnancy performed before the abortion 38

procedure. 39 (b) A test for anemia. 40 (c) Rh typing, unless reliable written documentation of blood type is 41

available. 42 (d) Other tests as indicated from the physical examination. 43

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4. An ultrasound evaluation for all patients. The rules shall require 1 that if a person who is not a physician performs an ultrasound examination, 2 that person shall have documented evidence that the person completed a course 3 in the operation of ultrasound equipment as prescribed in rule. The 4 physician or other health care professional shall review, at the request of 5 the patient, the ultrasound evaluation results with the patient before the 6 abortion procedure is performed, including the probable gestational age of 7 the fetus. 8

5. That the physician is responsible for estimating the gestational 9 age of the fetus based on the ultrasound examination and obstetric standards 10 in keeping with established standards of care regarding the estimation of 11 fetal age as defined in rule and shall write the estimate in the patient's 12 medical history. The physician shall keep original prints of each ultrasound 13 examination of a patient in the patient's medical history file. 14

E. The director shall adopt rules relating to the abortion procedure. 15 At a minimum these rules shall require: 16

1. That medical personnel is available to all patients throughout the 17 abortion procedure. 18

2. Standards for the safe conduct of abortion procedures that conform 19 to obstetric standards in keeping with established standards of care 20 regarding the estimation of fetal age as defined in rule. 21

3. Appropriate use of local anesthesia, analgesia and sedation if 22 ordered by the physician. 23

4. The use of appropriate precautions, such as the establishment of 24 intravenous access at least for patients undergoing second or third trimester 25 abortions. 26

5. The use of appropriate monitoring of the vital signs and other 27 defined signs and markers of the patient's status throughout the abortion 28 procedure and during the recovery period until the patient's condition is 29 deemed to be stable in the recovery room. 30

6. That any medication, drug or other substance used to induce or 31 cause a medication abortion, as defined in section 36-2151, is administered 32 in compliance with the Mifeprex final printing label protocol that is 33 approved by the United States food and drug administration and in effect as 34 of December 31, 2015. 35

F. The director shall adopt rules that prescribe minimum recovery room 36 standards. At a minimum these rules shall require that: 37

1. For a surgical abortion, immediate postprocedure care, or care 38 provided after inducing a medication abortion, consists of observation in a 39 supervised recovery room for as long as the patient's condition warrants. 40

2. The clinic arrange hospitalization if any complication beyond the 41 management capability of the staff occurs or is suspected. 42

3. A licensed health professional who is trained in the management of 43 the recovery area and is capable of providing basic cardiopulmonary 44

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resuscitation and related emergency procedures remains on the premises of the 1 abortion clinic until all patients are discharged. 2

4. For a surgical abortion, a physician with admitting privileges at a 3 health care institution that is classified by the director as a hospital 4 pursuant to section 36-405, subsection B and that is within thirty miles of 5 the abortion clinic remains on the premises of the abortion clinic until all 6 patients are stable and are ready to leave the recovery room and to 7 facilitate the transfer of emergency cases if hospitalization of the patient 8 or viable fetus is necessary. A physician shall sign the discharge order and 9 be readily accessible and available until the last patient is discharged. 10

5. A physician discusses RhO(d) immune globulin with each patient for 11 whom it is indicated and assures it is offered to the patient in the 12 immediate postoperative period or that it will be available to her within 13 seventy-two hours after completion of the abortion procedure. If the patient 14 refuses, a refusal form approved by the department shall be signed by the 15 patient and a witness and included in the medical record. 16

6. Written instructions with regard to postabortion coitus, signs of 17 possible problems and general aftercare are given to each patient. Each 18 patient shall have specific instructions regarding access to medical care for 19 complications, including a telephone number to call for medical emergencies. 20

7. There is a specified minimum length of time that a patient remains 21 in the recovery room by type of abortion procedure and duration of gestation. 22

8. The physician assures that a licensed health professional from the 23 abortion clinic makes a good faith effort to contact the patient by 24 telephone, with the patient's consent, within twenty-four hours after a 25 surgical abortion to assess the patient's recovery. 26

9. Equipment and services are located in the recovery room to provide 27 appropriate emergency resuscitative and life support procedures pending the 28 transfer of the patient or viable fetus to the hospital. 29

G. The director shall adopt rules that prescribe standards for 30 follow-up visits. At a minimum these rules shall require that: 31

1. For a surgical abortion, a postabortion medical visit is offered 32 and, if requested, scheduled for three weeks after the abortion, including a 33 medical examination and a review of the results of all laboratory tests. For 34 a medication abortion, the rules shall require that a postabortion medical 35 visit is scheduled between one week and three weeks after the initial dose 36 for a medication abortion to confirm the pregnancy is completely terminated 37 and to assess the degree of bleeding. 38

2. A urine pregnancy test is obtained at the time of the follow-up 39 visit to rule out continuing pregnancy. If a continuing pregnancy is 40 suspected, the patient shall be evaluated and a physician who performs 41 abortions shall be consulted. 42

H. The director shall adopt rules to prescribe minimum abortion clinic 43 incident reporting. At a minimum these rules shall require that: 44

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1. The abortion clinic records each incident resulting in a patient's 1 or viable fetus' serious injury occurring at an abortion clinic and shall 2 report them in writing to the department within ten days after the incident. 3 For the purposes of this paragraph, "serious injury" means an injury that 4 occurs at an abortion clinic and that creates a serious risk of substantial 5 impairment of a major body organ and includes any injury or condition that 6 requires ambulance transportation of the patient. 7

2. If a patient's death occurs, other than a fetal death properly 8 reported pursuant to law, the abortion clinic reports it to the department 9 not later than the next department work day. 10

3. Incident reports are filed with the department and appropriate 11 professional regulatory boards. 12

I. The director shall adopt rules relating to enforcement of this 13 article. At a minimum, these rules shall require that: 14

1. For an abortion clinic that is not in substantial compliance with 15 this article and the rules adopted pursuant to this article or that is in 16 substantial compliance but refuses to carry out a plan of correction 17 acceptable to the department of any deficiencies that are listed on the 18 department's statement of deficiency, the department may do any of the 19 following: 20

(a) Assess a civil penalty pursuant to section 36-431.01. 21 (b) Impose an intermediate sanction pursuant to section 36-427. 22 (c) Suspend or revoke a license pursuant to section 36-427. 23 (d) Deny a license. 24 (e) Bring an action for an injunction pursuant to section 36-430. 25 2. In determining the appropriate enforcement action, the department 26

consider the threat to the health, safety and welfare of the abortion 27 clinic's patients or the general public, including: 28

(a) Whether the abortion clinic has repeated violations of statutes or 29 rules. 30

(b) Whether the abortion clinic has engaged in a pattern of 31 noncompliance. 32

(c) The type, severity and number of violations. 33 J. The department shall not release personally identifiable patient or 34

physician information. 35 K. The rules adopted by the director pursuant to this section do not 36

limit the ability of a physician or other health professional to advise a 37 patient on any health issue. 38

Sec. 5. Section 36-2153, Arizona Revised Statutes, is amended to read: 39 36-2153. Informed consent; requirements; information; website; 40

signs; violation; civil relief; statute of 41 limitations 42

A. An abortion shall not be performed or induced without the voluntary 43 and informed consent of the woman on whom the abortion is to be performed or 44 induced. Except in the case of a medical emergency and in addition to the 45

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other requirements of this chapter, consent to an abortion is voluntary and 1 informed only if all of the following are true: 2

1. At least twenty-four hours before the abortion, the physician who 3 is to perform the abortion or the referring physician has informed the woman, 4 orally and in person, of: 5

(a) The name of the physician who will perform the abortion. 6 (b) The nature of the proposed procedure or treatment. 7 (c) The immediate and long-term medical risks associated with the 8

procedure that a reasonable patient would consider material to the decision 9 of whether or not to undergo the abortion. 10

(d) Alternatives to the procedure or treatment that a reasonable 11 patient would consider material to the decision of whether or not to undergo 12 the abortion. 13

(e) The probable gestational age of the unborn child at the time the 14 abortion is to be performed. 15

(f) The probable anatomical and physiological characteristics of the 16 unborn child at the time the abortion is to be performed. 17

(g) The medical risks associated with carrying the child to term. 18 2. At least twenty-four hours before the abortion, the physician who 19

is to perform the abortion, the referring physician or a qualified physician, 20 physician assistant, nurse, psychologist or licensed behavioral health 21 professional to whom the responsibility has been delegated by either 22 physician has informed the woman, orally and in person, that: 23

(a) Medical assistance benefits may be available for prenatal care, 24 childbirth and neonatal care. 25

(b) The father of the unborn child is liable to assist in the support 26 of the child, even if he has offered to pay for the abortion. In the case of 27 rape or incest, this information may be omitted. 28

(c) Public and private agencies and services are available to assist 29 the woman during her pregnancy and after the birth of her child if she 30 chooses not to have an abortion, whether she chooses to keep the child or 31 place the child for adoption. 32

(d) It is unlawful for any person to coerce a woman to undergo an 33 abortion. 34

(e) The woman is free to withhold or withdraw her consent to the 35 abortion at any time without affecting her right to future care or treatment 36 and without the loss of any state or federally funded benefits to which she 37 might otherwise be entitled. 38

(f) The department of health services maintains a website that 39 describes the unborn child and lists the agencies that offer alternatives to 40 abortion. 41

(g) The woman has a right to review the website and that a printed 42 copy of the materials on the website will be provided to her free of charge 43 if she chooses to review these materials. 44

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(h) It may be possible to reverse the effects of a medication abortion 1 if the woman changes her mind but that time is of the essence. 2

(i) Information on and assistance with reversing the effects of a 3 medication abortion is available on the department of health services' 4 website. 5

3. The information in paragraphs 1 and 2 of this subsection is 6 provided to the woman individually and in a private room to protect her 7 privacy and to ensure that the information focuses on her individual 8 circumstances and that she has adequate opportunity to ask questions. 9

4. The woman certifies in writing before the abortion that the 10 information required to be provided pursuant to paragraphs 1 and 2 of this 11 subsection has been provided. 12

B. IF A WOMAN HAS TAKEN MIFEPRISTONE AS PART OF A TWO-DRUG REGIMEN TO 13 TERMINATE HER PREGNANCY, HAS NOT YET TAKEN THE SECOND DRUG AND CONSULTS AN 14 ABORTION CLINIC QUESTIONING HER DECISION TO TERMINATE HER PREGNANCY OR 15 SEEKING INFORMATION REGARDING THE HEALTH OF HER FETUS OR THE EFFICACY OF 16 MIFEPRISTONE ALONE TO TERMINATE A PREGNANCY, THE ABORTION CLINIC STAFF SHALL 17 INFORM THE WOMAN THAT THE USE OF MIFEPRISTONE ALONE TO END A PREGNANCY IS NOT 18 ALWAYS EFFECTIVE AND THAT SHE SHOULD IMMEDIATELY CONSULT A PHYSICIAN IF SHE 19 WOULD LIKE MORE INFORMATION. 20

B. C. If a medical emergency compels the performance of an abortion, 21 the physician shall inform the woman, before the abortion if possible, of the 22 medical indications supporting the physician's judgment that an abortion is 23 necessary to avert the woman's death or to avert substantial and irreversible 24 impairment of a major bodily function. 25

C. D. The department of health services shall establish and shall 26 annually update a website that includes a link to a printable version of all 27 materials listed on the website. The materials must be written in an easily 28 understood manner and printed in a typeface that is large enough to be 29 clearly legible. The website must include all of the following materials: 30

1. Information that is organized geographically by location and that 31 is designed to inform the woman about public and private agencies and 32 services that are available to assist a woman through pregnancy, at 33 childbirth and while her child is dependent, including adoption agencies. 34 The materials shall include a comprehensive list of the agencies, a 35 description of the services they offer and the manner in which these agencies 36 may be contacted, including the agencies' telephone numbers and website 37 addresses. 38

2. Information on the availability of medical assistance benefits for 39 prenatal care, childbirth and neonatal care. 40

3. A statement that it is unlawful for any person to coerce a woman to 41 undergo an abortion. 42

4. A statement that any physician who performs an abortion on a woman 43 without obtaining the woman's voluntary and informed consent or without 44

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affording her a private medical consultation may be liable to the woman for 1 damages in a civil action. 2

5. A statement that the father of a child is liable to assist in the 3 support of that child, even if the father has offered to pay for an abortion, 4 and that the law allows adoptive parents to pay costs of prenatal care, 5 childbirth and neonatal care. 6

6. Information that is designed to inform the woman of the probable 7 anatomical and physiological characteristics of the unborn child at two-week 8 gestational increments from fertilization to full term, including pictures or 9 drawings representing the development of unborn children at two-week 10 gestational increments and any relevant information on the possibility of the 11 unborn child's survival. The pictures or drawings must contain the 12 dimensions of the unborn child and must be realistic and appropriate for each 13 stage of pregnancy. The information provided pursuant to this paragraph must 14 be objective, nonjudgmental and designed to convey only accurate scientific 15 information about the unborn child at the various gestational ages. 16

7. Objective information that describes the methods of abortion 17 procedures commonly employed, the medical risks commonly associated with each 18 procedure, the possible detrimental psychological effects of abortion and the 19 medical risks commonly associated with carrying a child to term. 20

8. Information on the potential ability of qualified medical 21 professionals to reverse a medication abortion, including information 22 directing women where to obtain further information and assistance in 23 locating a medical professional who can aid in the reversal of a medication 24 abortion EXPLAINING THE EFFICACY OF MIFEPRISTONE TAKEN ALONE, WITHOUT A 25 FOLLOW-UP DRUG AS PART OF A TWO-DRUG REGIMEN, TO TERMINATE A PREGNANCY AND 26 ADVISING A WOMAN TO IMMEDIATELY CONTACT A PHYSICIAN IF THE WOMAN HAS TAKEN 27 ONLY MIFEPRISTONE AND QUESTIONS HER DECISION TO TERMINATE HER PREGNANCY OR 28 SEEKS INFORMATION REGARDING THE HEALTH OF HER FETUS. 29

D. E. An individual who is not a physician shall not perform a 30 surgical abortion. 31

E. F. A person shall not write or communicate a prescription for a 32 drug or drugs to induce an abortion or require or obtain payment for a 33 service provided to a patient who has inquired about an abortion or scheduled 34 an abortion until the expiration of the twenty-four-hour reflection period 35 required by subsection A of this section. 36

F. G. A person shall not intimidate or coerce in any way any person 37 to obtain an abortion. A parent, a guardian or any other person shall not 38 coerce a minor to obtain an abortion. If a minor is denied financial support 39 by the minor's parents, guardians or custodian due to the minor's refusal to 40 have an abortion performed, the minor is deemed emancipated for the purposes 41 of eligibility for public assistance benefits, except that the emancipated 42 minor may not use these benefits to obtain an abortion. 43

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G. H. An abortion clinic as defined in section 36-449.01 shall 1 conspicuously post signs that are visible to all who enter the abortion 2 clinic, that are clearly readable and that state it is unlawful for any 3 person to force a woman to have an abortion and a woman who is being forced 4 to have an abortion has the right to contact any local or state law 5 enforcement or social service agency to receive protection from any actual or 6 threatened physical, emotional or psychological abuse. The signs shall be 7 posted in the waiting room, consultation rooms and procedure rooms. 8

H. I. A person shall not require a woman to obtain an abortion as a 9 provision in a contract or as a condition of employment. 10

I. J. A physician who knowingly violates this section commits an act 11 of unprofessional conduct and is subject to license suspension or revocation 12 pursuant to title 32, chapter 13 or 17. 13

J. K. In addition to other remedies available under the common or 14 statutory law of this state, any of the following may file a civil action to 15 obtain appropriate relief for a violation of this section: 16

1. A woman on whom an abortion has been performed without her informed 17 consent as required by this section. 18

2. The father of the unborn child if THE FATHER WAS married to the 19 mother at the time she received the abortion, unless the pregnancy resulted 20 from the plaintiff's criminal conduct. 21

3. The maternal grandparents of the unborn child if the mother was not 22 at least eighteen years of age at the time of the abortion, unless the 23 pregnancy resulted from the plaintiff's criminal conduct. 24

K. L. A civil action filed pursuant to subsection J K of this 25 section shall be brought in the superior court in the county in which the 26 woman on whom the abortion was performed resides and may be based on a claim 27 that failure to obtain informed consent was a result of simple negligence, 28 gross negligence, wantonness, wilfulness, intention or any other legal 29 standard of care. Relief pursuant to subsection J K of this section 30 includes the following: 31

1. Money damages for all psychological, emotional and physical 32 injuries resulting from the violation of this section. 33

2. Statutory damages in an amount equal to five thousand dollars or 34 three times the cost of the abortion, whichever is greater. 35

3. Reasonable attorney fees and costs. 36 L. M. A civil action brought pursuant to this section must be 37

initiated within six years after the violation occurred. 38 Sec. 6. Legislative findings 39 A. The legislature finds that: 40 1. The state of Arizona has a legitimate concern for the public's 41

health and safety. Williamson v. Lee Optical, 348 U.S. 483, 486 (1955); 42 Cohen v. State, 121 Ariz. 6, 10, 588 P.2d 299, 303 (1978). 43

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2. The state of Arizona "has legitimate interests from the outset of 1 the pregnancy in protecting the health of women." Planned Parenthood of 2 Southeastern Pennsylvania v. Casey, 505 U.S. 833, 846 (1992); see also 3 Planned Parenthood Arizona, Inc. v. American Ass'n of Pro-Life Obstetricians 4 & Gynecologists, 257 P.3d 181, 194 (Ariz. App. Div. 1, 2011). More 5 specifically, Arizona "has a legitimate concern with the health of women who 6 undergo abortions." Akron v. Akron Ctr. for Reproductive Health, Inc., 462 7 U.S. 416, 428-29 (1983). 8

3. The use of mifepristone presents significant medical risks to 9 women, including but not limited to C. sordellii bacterial infection, septic 10 shock, toxic shock syndrome, adult respiratory distress syndrome from sepsis, 11 Escheria coli sepsis, group B Streptococcus septicemia, disseminated 12 intravascular coagulopathy (DIC) with heptic and renal failure, severe pelvic 13 infection and massive hemorrhage. 14

4. Abortion-inducing drugs are associated with an increased risk of 15 complications relative to surgical abortion. The risk of complications 16 increases with increasing gestational age, and, in the instance of 17 mifepristone, with failure to complete the two-step dosage process. 18

5. Section 36-449.03, subsection E, paragraph 6, Arizona Revised 19 Statutes, as added by Laws 2012, chapter 250, section 2, is preliminarily 20 enjoined. 21

6. Recent developments by the United States food and drug 22 administration have led to expanded limits for the use of abortion-inducing 23 drugs, specifically in regard to its revised regimen for the use of Mifeprex 24 (mifepristone). 25

7. Abortion providers challenging section 36-2153, subsection A, 26 paragraph 2, subdivisions (h) and (i) and subsection C, paragraph 8, Arizona 27 Revised Statutes, as added by Laws 2015, chapter 87, section 4, admit in 28 court filings that "women can carry to term after taking mifepristone alone", 29 "mifepristone was never approved for use on its own in an abortion, and it is 30 not currently used for such, because it is not sufficiently effective unless 31 used in combination with misoprostol", "mifepristone has never been —— and 32 is not now —— considered to be a sufficiently effective abortifacient on its 33 own" and "the range of continuing pregnancies after mifepristone alone may be 34 anywhere from between 20 percent and 80 percent." Supplemental Declaration 35 of Courtney Schreiber, M.D., M.P.H., Case No. CV-15-01022-PHX-SPL, FN 15, 36 ¶¶ 22, 24; Deposition of Courtney A. Schreiber, M.D., 10/1/2015, page 214. 37

B. For the reasons prescribed in subsection A of this section, the 38 legislature's purposes in enacting this legislation include: 39

1. Resolving pending litigation. 40 2. Providing time for the legislature to research and examine how to 41

best protect the health and safety of women who may choose to have a 42 medication abortion. 43

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3. Ensuring that women who may question their decision to have a 1 medication abortion after taking mifepristone alone are properly informed, 2 consistent with what abortion providers admit in court filings, that the use 3 of mifepristone alone to end a pregnancy is not always effective. 4

Sec. 7. Legislative intent 5 It is the intent of the legislature that the changes made by this act 6

to section 32-1974, Arizona Revised Statutes, allow families greater access 7 to immunizations and vaccinations, maintain and enhance collaboration between 8 pharmacists and primary care providers and affirm the importance of annual 9 well-child visits in a medical home during critical developmental ages. This 10 act recognizes the efficiencies and improved outcomes when care is delivered 11 through a medical home where a primary care provider working in collaboration 12 with the family and other providers oversees acute, chronic and preventative 13 health needs in a coordinated and comprehensive fashion. 14