6 | | - | ENROLLED |
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7 | | - | |
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8 | | - | AN ACT |
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9 | | - | |
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10 | | - | |
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11 | | - | ENTITLED An Act to revise provisions related to pharmacy and to increase fees. |
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12 | | - | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: |
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13 | | - | Section 1. That § 13-33A-4 be AMENDED: |
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14 | | - | 13-33A-4. Any school may acquire and maintain a stock of epinephrine auto - |
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15 | | - | injectors pursuant to a prescription issued by an authorized health care provider for use |
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16 | | - | in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions |
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17 | | - | of this section are not subject to the prescription requirements in chapter 36-11. |
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18 | | - | Section 2. That § 36-11-2 be AMENDED: |
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19 | | - | 36-11-2. Terms used in this chapter mean: |
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20 | | - | (1) "Biological product," as defined in 42 U.S.C. § 262(i), (January 1, 2018); |
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21 | | - | (2) "Board," the State Board of Pharmacy; |
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22 | | - | (3) "Brand name," the proprietary or registered trademark name given to a drug |
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23 | | - | product by its manufacturer, labeler, or distributor and placed on the drug or on |
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24 | | - | its container, label, or wrapping at the time of packaging; |
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25 | | - | (4) "Compounding," the preparation, mixing, assembling, packaging, or labeling of a |
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26 | | - | drug or drug device as the result of a practitioner's prescription drug order or an |
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27 | | - | initiative based on the pharmacist/patient/practitioner relationship in the course of |
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28 | | - | professional practice or for the purpose of or as an incident to research, teaching, |
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29 | | - | or chemical analysis and not for sale or dispensing. The term also includes the |
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30 | | - | preparation of drug or drug devices in anticipation of prescription drug orders based |
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31 | | - | on routine, regularly observed prescribing patterns; |
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32 | | - | (5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device |
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33 | | - | from one person to another, whether or not for a consideration; |
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34 | | - | (6) "Dispensing," the preparation and delivery of a drug to a patient or a patient's |
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35 | | - | agent pursuant to a prescription drug order in a suitable container with appropriate 25.365.19 2 1016 |
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36 | | - | HB1016 ENROLLED |
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37 | | - | labeling for subsequent administration to or use by a patient. The term includes |
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38 | | - | preparation of labels for drug devices if the labeling is related to the dosage and |
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39 | | - | administration of drugs; |
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40 | | - | (7) "Distributing," the delivery of a drug or drug device other than by administration |
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41 | | - | or dispensing; |
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42 | | - | (8) "Drug administration," the direct application of a drug or drug device by injection, |
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43 | | - | inhalation, ingestion, or any other means to the body of a patient or research |
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44 | | - | subject; |
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45 | | - | (9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, or |
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46 | | - | other product used in combination with a drug to provide effective management of |
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47 | | - | medication regimens; |
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48 | | - | (10) "Equivalent drug product," a drug product, other than a biological product, that is |
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49 | | - | considered to be therapeutically equivalent to other pharmaceutically equivalent |
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50 | | - | products as determined by the edition of Approved Drug Products with Therapeutic |
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51 | | - | Equivalence Evaluations adopted by the board through rules promulgated pursuant |
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52 | | - | to chapter 1-26; |
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53 | | - | (11) "Interchangeable biological product," a biological product that the United States |
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54 | | - | Food and Drug Administration either has licensed and determined meets the |
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55 | | - | standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), (January 1, |
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56 | | - | 2018), or has determined is therapeutically equivalent, as set forth in the edition |
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57 | | - | of Approved Drug Products with Therapeutic Equivalence Evaluations as adopted |
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58 | | - | by the board through rules promulgated pursuant to chapter 1-26; |
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59 | | - | (12) "Labeling," the process of preparing and affixing a label to any drug or drug device |
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60 | | - | container exclusive of the labeling by the manufacturer, packer, or distributor of a |
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61 | | - | nonprescription drug or commercially packaged legend drug or drug device; |
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62 | | - | (13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the |
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63 | | - | prevention, relief, or cure of diseases when used either internally or externally by |
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64 | | - | man or for animals; |
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65 | | - | (14) "Nonprescription drugs," drugs that are labeled for use by the general public in |
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66 | | - | accordance with 21 U.S.C. § 352 (January 1, 2025), and may be sold without a |
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67 | | - | prescription drug order in accordance with 21 U.S.C. § 353 (January 1, 2025). The |
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68 | | - | term does not include drugs that are required by federal law to bear the statement |
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69 | | - | "Caution: federal law prohibits dispensing without prescription," drugs intended for |
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70 | | - | human use by hypodermic injection, or animal remedies regulated by chapter 39- |
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71 | | - | 18; 25.365.19 3 1016 |
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72 | | - | HB1016 ENROLLED |
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73 | | - | (15) "Patient counseling," oral communication by the pharmacist of information to the |
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74 | | - | patient or caregiver to improve therapy by ensuring proper use of drugs and drug |
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75 | | - | devices; |
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76 | | - | (16) "Pharmaceutical care," provision of drug therapy and other pharmaceutical patient |
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77 | | - | care services intended to achieve outcomes related to curing or preventing a |
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78 | | - | disease, eliminating or reducing a patient's symptoms, or arresting or slowing a |
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79 | | - | disease process; |
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80 | | - | (17) "Pharmacist," a person licensed by the board to engage in the practice of |
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81 | | - | pharmacy; |
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82 | | - | (18) "Pharmacy," any place of business within or outside this state where drugs are |
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83 | | - | dispensed and pharmaceutical care is provided to residents of this state; |
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84 | | - | (19) "Practitioner," a person licensed, registered, or otherwise authorized by the |
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85 | | - | jurisdiction in which the person is practicing to prescribe drugs in the course of |
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86 | | - | professional practice; |
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87 | | - | (20) "Prescription drug order," a written or oral order of a practitioner for a drug or drug |
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88 | | - | device for a specific patient; |
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89 | | - | (21) "Proper name," the nonproprietary name for a biological product designated by the |
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90 | | - | United States Food and Drug Administration license for use upon each package of |
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91 | | - | the product; and |
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92 | | - | (22) "Registered pharmacy technician," a person registered by the board who is |
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93 | | - | employed by a pharmacy to assist pharmacists in the practice of pharmacy by |
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94 | | - | performing specific tasks delegated by and under the immediate personal |
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95 | | - | supervision and control of a pharmacist, as permitted by the board. |
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96 | | - | Section 3. That § 36-11-2.1 be AMENDED: |
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97 | | - | 36-11-2.1. For the purpose of this chapter, "drugs" are: |
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98 | | - | (1) Articles recognized in the official United States Pharmacopoeia or the official |
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99 | | - | National Formulary, as adopted by the board through rules promulgated pursuant |
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100 | | - | to chapter 1-26, or recognized in the official Homeopathic Pharmacopoeia of the |
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101 | | - | United States as in effect on January 1, 1993; |
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102 | | - | (2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention |
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103 | | - | of disease in humans or other animals; |
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104 | | - | (3) Articles, other than food, intended to affect the structure or any functions of the |
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105 | | - | human body; and |
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106 | | - | (4) Articles intended for use as a component of any articles specified in this section. 25.365.19 4 1016 |
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107 | | - | HB1016 ENROLLED |
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108 | | - | The term "drugs" excludes medical devices. |
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109 | | - | For the purposes of this section, "medical device" means an instrument, apparatus, |
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110 | | - | implement, machine, contrivance, implant, in vitro reagent, or other similar or related |
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111 | | - | article, including any component, part, or accessory, that is intended for use in the |
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112 | | - | diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention |
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113 | | - | of disease in humans or animals, or is intended to affect the structure or any function of |
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114 | | - | the body of humans or animals, that does not achieve any of its princi pal intended |
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115 | | - | purposes through chemical action within or on the body of humans or animals and that is |
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116 | | - | not dependent upon being metabolized for achievement of any of its principal intended |
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117 | | - | purposes. |
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118 | | - | Section 4. That § 36-11-5 be AMENDED: |
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119 | | - | 36-11-5. The board shall hold meetings for the examination of applicants for |
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120 | | - | licensure and registration, and the transaction of other business that pertains to its duties. |
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121 | | - | Special meetings of the board may be held whenever deemed necessary by a majority of |
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122 | | - | the board. Three members of the board constitutes a quorum. |
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123 | | - | Section 5. That § 36-11-13 be AMENDED: |
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124 | | - | 36-11-13. It is a Class 2 misdemeanor for any person other than a pharmacist to |
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125 | | - | engage in the practice of pharmacy, except as provided by § 36-11-14. |
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126 | | - | Section 6. That § 36-11-15 be AMENDED: |
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127 | | - | 36-11-15. Any person, other than a pharmacist, who compounds or dispenses |
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128 | | - | drugs, medicines, or poisons, or who keeps a pharmacy or store for retailing or |
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129 | | - | compounding medicines, or who takes, uses, or exhibits the title of a pharmacist, is guilty |
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130 | | - | of a Class 2 misdemeanor. |
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131 | | - | Section 7. That § 36-11-16 be AMENDED: |
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132 | | - | 36-11-16. The board shall issue a license to practice pharmacy to an individual |
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133 | | - | who: |
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134 | | - | (1) Submits an application prescribed by the board; |
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135 | | - | (2) Submits an application fee set by the board through rules promulgated in |
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136 | | - | accordance with chapter 1-26, but not exceeding thirty-five dollars; |
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137 | | - | (3) Is of good moral character and temperate habits; 25.365.19 5 1016 |
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138 | | - | HB1016 ENROLLED |
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139 | | - | (4) Is not less than eighteen years of age; |
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140 | | - | (5) Is a graduate of a college of pharmacy recognized and approved by the board; |
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141 | | - | (6) Has had the necessary experience as determined by the board in the practice of |
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142 | | - | pharmacy under a regularly licensed pharmacist in a pharmacy where physicians' |
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143 | | - | prescriptions are compounded; and |
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144 | | - | (7) Has passed an examination prescribed by the board. |
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145 | | - | The board may allow credit for suitable military and research activities in the field |
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146 | | - | of pharmacy as part of the experience requirement. |
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147 | | - | Section 8. That § 36-11-19 be AMENDED: |
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148 | | - | 36-11-19. The board may issue a license to practice pharmacy to individual who |
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149 | | - | applies to the board and submits satisfactory proof that the individual has been licensed |
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150 | | - | by examination in another state, provided that the other state required a degree of |
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151 | | - | competency at the time the individual was licensed at least equal to that required in this |
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152 | | - | state at that same time. |
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153 | | - | The board may, in determining the degree of fitness required by other states' |
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154 | | - | boards of pharmacy for granting licensure, join with other states' boards of pharmacy. |
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155 | | - | Every individual applying for licensure pursuant to this section shall pay to the board an |
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156 | | - | application fee, not to exceed one hundred fifty dollars, set by the board by rule |
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157 | | - | promulgated pursuant to chapter 1-26. |
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158 | | - | Section 9. That § 36-11-19.1 be AMENDED: |
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159 | | - | 36-11-19.1. A pharmacist may: |
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160 | | - | (1) Perform drug administration pursuant to a prescription drug order; |
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161 | | - | (2) Perform drug reviews; |
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162 | | - | (3) Perform or participate in scientific or clinical drug or drug-related research as an |
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163 | | - | investigator or in collaboration with other investigators; |
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164 | | - | (4) Interpret and apply pharmacokinetic data and other pertinent laboratory data to |
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165 | | - | design safe and effective drug dosage regimens; |
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166 | | - | (5) Participate in drug and drug device selection pursuant to a prescription drug order; |
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167 | | - | (6) Initiate or modify drug therapy by protocol or other legal authority established and |
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168 | | - | approved within a licensed health care facility or by a practitioner authorized to |
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169 | | - | prescribe drugs; and |
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170 | | - | (7) Provide information on prescription drugs, which may include advising, consulting, |
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171 | | - | and educating, as necessary or as required, patients, the public, and other health 25.365.19 6 1016 |
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172 | | - | HB1016 ENROLLED |
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173 | | - | care providers on the rational, safe and cost-effective use of drugs, including |
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174 | | - | therapeutic values, content, hazards and appropriate use. |
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175 | | - | The board shall establish standards for drug administration, in rules promulgated |
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176 | | - | pursuant to chapter 1-26, with the approval of a committee composed of two persons |
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177 | | - | appointed by the board, two persons appointed by the South Dakota Board of Nursing, |
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178 | | - | and two persons appointed by the State Board of Medical and Osteopathic Examiners. |
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179 | | - | Section 10. That § 36-11-19.5 be AMENDED: |
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180 | | - | 36-11-19.5. Each nonresident pharmacy license expires on June thirtieth following |
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181 | | - | the date of issuance. The board shall provide a renewal application to each licensee before |
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182 | | - | June first of each year. If the licensee does not submit a renewal application, accompanied |
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183 | | - | by the renewal fee, before the expiration date, the license lapses on the date of expiration. |
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184 | | - | The board shall promulgate rules, pursuant to chapter 1-26, to establish the renewal fee, |
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185 | | - | which may not exceed two hundred dollars. If the renewal application is submitted after |
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186 | | - | the expiration of the license, the board must assess a fifty-dollar late fee and may reinstate |
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187 | | - | the license. |
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188 | | - | If a majority of ownership of a licensed nonresident pharmacy changes, the new |
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189 | | - | owners must, within thirty days after the ownership change: |
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190 | | - | (1) Submit the renewal application, indicating the change of ownership; and |
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191 | | - | (2) Pay the renewal fee established by the board as provided in this section. |
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192 | | - | Section 11. That § 36-11-19.6 be AMENDED: |
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193 | | - | 36-11-19.6. The board may deny, revoke, or suspend a nonresident pharmacy |
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194 | | - | license for conduct that causes serious bodily injury or serious psychological injury to a |
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195 | | - | resident of this state, if the board has referred the matter to the regulatory or licensing |
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196 | | - | agency in the state in which the nonresident pharmacy is located and the regulatory or |
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197 | | - | licensing agency fails to initiate an investigation within forty-five days after the referral. |
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198 | | - | Any action taken to deny, revoke, or suspend a nonresident pharmacy license is a |
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199 | | - | contested case proceeding pursuant to chapter 1-26. |
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200 | | - | Section 12. That § 36-11-20 be AMENDED: |
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201 | | - | 36-11-20. The board may, in compliance with chapter 1-26, suspend, revoke, or |
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202 | | - | refuse to issue or renew a license to practice pharmacy to any person who: |
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203 | | - | (1) Is guilty of a felony or a misdemeanor involving moral turpitude; 25.365.19 7 1016 |
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204 | | - | HB1016 ENROLLED |
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205 | | - | (2) Is addicted to the use of alcoholic liquors or narcotic drugs to such an extent as to |
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206 | | - | render the person unfit to practice pharmacy with reasonable skill and safety; |
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207 | | - | (3) Procured a license by fraud or by false representation; |
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208 | | - | (4) Is permitting or engaging in the unauthorized sale of legend or controlled drugs or |
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209 | | - | substances; or |
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210 | | - | (5) The board finds to be in violation of any law, rule, or regulation governing |
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211 | | - | pharmacists. |
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212 | | - | Section 13. That § 36-11-23 be AMENDED: |
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213 | | - | 36-11-23. To renew a license to practice pharmacy, a pharmacist must, on or |
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214 | | - | before September thirtieth of each year, submit a renewal application and pay to the board |
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215 | | - | a renewal fee set by the board in rules promulgated in accordance with chapter 1-26, not |
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216 | | - | to exceed one hundred fifty dollars. Upon application and payment of the fee, the board |
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217 | | - | shall renew the license. If a pharmacist fails to apply and pay the renewal fee, the license |
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218 | | - | expires. |
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219 | | - | The board may reinstate an expired license if the individual: |
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220 | | - | (1) Applies for reinstatement; and |
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221 | | - | (2) Pays all delinquent fees, plus a fifty-dollar late fee. |
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222 | | - | Section 14. That § 36-11-25 be AMENDED: |
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223 | | - | 36-11-25. The board may issue a pharmacy intern certificate to an individual who |
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224 | | - | is gaining experience as a qualification for licensure as a pharmacist. Any pharmacy intern |
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225 | | - | issued an intern certificate shall perform the internship pursuant to rules promulgated by |
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226 | | - | the board in accordance with chapter 1-26. Nothing in this section may be construed as |
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227 | | - | giving a pharmacy intern authority to fill any prescription, except under the supervision |
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228 | | - | and in the presence of the pharmacist. |
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229 | | - | Section 15. That § 36-11-26 be AMENDED: |
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230 | | - | 36-11-26. If the board is satisfied that any pharmacist is incompetent or |
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231 | | - | disqualified to perform the duties of a pharmacist pursuant to § 36-11-20 or as |
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232 | | - | contemplated by the provisions of this chapter, it may, in compliance with chapter 1-26: |
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233 | | - | (1) Issue a reprimand to the pharmacist; |
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234 | | - | (2) Place the pharmacist on probation and supervision; 25.365.19 8 1016 |
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235 | | - | HB1016 ENROLLED |
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236 | | - | (3) Suspend the pharmacist's license until the pharmacist completes a course of |
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237 | | - | therapy, treatment, training, or any combination thereof; |
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238 | | - | (4) Suspend the pharmacist's license for a fixed period; and |
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239 | | - | (5) Revoke the pharmacist's license. |
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240 | | - | An individual may appeal a decision of the board as provided in chapter 1-26. |
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241 | | - | Section 16. That § 36-11-30 be AMENDED: |
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242 | | - | 36-11-30. A person may not open or operate a pharmacy unless the pharmacy is |
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243 | | - | licensed by the board. |
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244 | | - | A violation of this section is a Class 2 misdemeanor. Each day of violation is a |
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245 | | - | separate offense. |
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246 | | - | Section 17. That § 36-11-31 be AMENDED: |
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247 | | - | 36-11-31. Only a person that has a pharmacy license issued by the board may: |
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248 | | - | (1) Carry on, conduct, or transact business under a name that contains the term or |
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249 | | - | words "drugstore," "pharmacy," or any term implying the operation of a pharmacy; |
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250 | | - | and |
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251 | | - | (2) Advertise, describe, or refer to a place of business, in any manner, by the terms |
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252 | | - | "drugstore" or "pharmacy," or any other term or words implying the operation of |
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253 | | - | a pharmacy. |
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254 | | - | A violation of this section is a Class 2 misdemeanor. |
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255 | | - | Section 18. That § 36-11-32 be AMENDED: |
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256 | | - | 36-11-32. The board shall issue a pharmacy license to a pharmacist in good |
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257 | | - | standing, if the pharmacist: |
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258 | | - | (1) Submits a form prescribed by the board; and |
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259 | | - | (2) Pays a fee, not to exceed two hundred dollars, set by the board in rules |
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260 | | - | promulgated in accordance with chapter 1-26. |
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261 | | - | Section 19. That § 36-11-33 be AMENDED: |
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262 | | - | 36-11-33. The board may issue to a pharmacist in good standing a license to |
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263 | | - | operate a part-time pharmacy in a hospital, nursing facility, or related facility, provided |
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264 | | - | that the pharmacy services are limited to inpatients or residents of the facility. |
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265 | | - | The board may issue a license under this section if: 25.365.19 9 1016 |
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266 | | - | HB1016 ENROLLED |
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267 | | - | (1) The pharmacist submits a form prescribed by the board and pays a fee, not to |
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268 | | - | exceed two hundred dollars, set by the board in rules promulgated in accordance |
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269 | | - | with chapter 1-26; and |
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270 | | - | (2) The merchandise and fixtures of the pharmacy are owned by a person other than |
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271 | | - | the pharmacist applying for the license. |
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272 | | - | The pharmacist must comply with the provisions of this chapter and with minimum |
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273 | | - | standards as established by the board in rules promulgated pursuant to chapter 1-26. |
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274 | | - | Section 20. That § 36-11-34 be AMENDED: |
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275 | | - | 36-11-34. The board may not issue a pharmacy license to any pharmacist |
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276 | | - | applicant unless: |
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277 | | - | (1) The applicant is the owner, or part owner, of the merchandise and fixtures of the |
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278 | | - | place of business for which the pharmacy license is applied for; |
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279 | | - | (2) The application is made jointly with a pharmacist owner; or |
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280 | | - | (3) The nonpharmacist owner of the merchandise and fixtures of the place of business |
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281 | | - | for which the pharmacy license is applied for, has submitted an affidavit on a form |
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282 | | - | prescribed by the board delegating complete responsibility for the pharmaceutical |
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283 | | - | services in said place of business to the pharmacist applicant. |
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284 | | - | Section 21. That § 36-11-35 be AMENDED: |
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285 | | - | 36-11-35. Each pharmacy license expires on June thirtieth following the date of |
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286 | | - | issue. To renew a pharmacy license, the pharmacist must submit a renewal application on |
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287 | | - | or before June thirtieth on a form prescribed by the board, and pay the renewal fee set |
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288 | | - | by the board in rules promulgated in accordance with chapter 1-26, but not exceeding two |
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289 | | - | hundred dollars. If the renewal application and fee is submitted after the expiration of the |
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290 | | - | license, the board must assess a fifty-dollar late fee and may reinstate the license. |
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291 | | - | If a majority ownership of the pharmacy changes, the new owners must, within |
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292 | | - | thirty days after ownership change: |
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293 | | - | (1) Submit the renewal application, indicating the change of ownership; and |
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294 | | - | (2) Pay the renewal fee established by the board as provided in this section. |
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295 | | - | Section 22. That § 36-11-36 be AMENDED: |
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296 | | - | 36-11-36. Each pharmacy license issued by the board must be posted in a place |
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297 | | - | in the pharmacy that is viewable by the public. 25.365.19 10 1016 |
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298 | | - | HB1016 ENROLLED |
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299 | | - | Section 23. That § 36-11-37 be AMENDED: |
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300 | | - | 36-11-37. A pharmacy license may be transferred to another pharmacist, |
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301 | | - | provided an application for the transfer of the license is made upon a form prescribed by |
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302 | | - | the board and upon payment of a fifty dollar fee. The application for transfer must be filed |
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303 | | - | with the board not more than ten days after the transfer of active management is made. |
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304 | | - | If the application for transfer is received by the board after ten days, the pharmacy license |
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305 | | - | is void, and the pharmacist must reapply for the license. |
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306 | | - | Section 24. That § 36-11-38 be AMENDED: |
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307 | | - | 36-11-38. In the event of the death of the pharmacist in active management, the |
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308 | | - | pharmacy license issued to the deceased under this chapter shall, within one hundred |
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309 | | - | twenty days after the date of death or on June thirtieth, whichever is sooner, become null |
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310 | | - | and void, unless the license is transferred as provided in § 36-11-37,. |
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311 | | - | Section 25. That § 36-11-39 be AMENDED: |
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312 | | - | 36-11-39. The change of location of any pharmacy for which a license has been |
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313 | | - | issued from one municipality to another within this state, or the cessation of business by |
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314 | | - | the pharmacy, must be reported to the board within ten days from the occurrence on |
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315 | | - | forms prescribed by the board. |
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316 | | - | Section 26. That § 36-11-41 be AMENDED: |
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317 | | - | 36-11-41. A pharmacy licensed by the board must: |
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318 | | - | (1) Be equipped with the pharmaceutical instruments and utensils prescribed by the |
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319 | | - | board in rules promulgated in accordance with chapter 1-26; |
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320 | | - | (2) Possess a stock of pharmaceuticals adequate to serve the needs of the community |
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321 | | - | in which the pharmacy is located; |
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322 | | - | (3) Have on file at all times the publications and supplements of formularies and drug |
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323 | | - | information prescribed by the board, by rules promulgated pursuant to chapter 1- |
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324 | | - | 26; and |
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325 | | - | (4) Be maintained and operated in a clean and sanitary condition, free from unhealth, |
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326 | | - | foreign, or injurious contamination. |
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327 | | - | Section 27. That § 36-11-43 be AMENDED: 25.365.19 11 1016 |
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328 | | - | HB1016 ENROLLED |
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329 | | - | 36-11-43. The board may, in rules promulgated in accordance with chapter 1-26, |
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330 | | - | adopt a code of professional ethics for pharmacists in this state. The board shall consider |
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331 | | - | the recommendations of the South Dakota Pharmacists Association in adopting the code |
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332 | | - | or changes made thereto. The code may not contain any provision that would in any way |
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333 | | - | restrain, prohibit, or attempt to regulate the rights of any pharmacist employed in a |
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334 | | - | licensed pharmacy. Violation of the code of professional ethics may not be the basis for |
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335 | | - | criminal prosecution unless otherwise declared unlawful. |
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336 | | - | Section 28. That § 36-11-44 be AMENDED: |
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337 | | - | 36-11-44. Any pharmacist who permits the compounding or dispensing of |
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338 | | - | prescriptions or the vending of drugs in the pharmacist's place of business, except under |
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339 | | - | the personal supervision of a pharmacist, or any pharmacist who, while continuing in |
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340 | | - | business, makes any false representations to procure a license for the pharmacist or any |
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341 | | - | other person, is guilty of a Class 2 misdemeanor. |
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342 | | - | Section 29. That § 36-11-48 be AMENDED: |
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343 | | - | 36-11-48. The board may suspend or revoke, in accordance with chapter 1-26, |
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344 | | - | any pharmacy license issued under this chapter on the following grounds: |
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345 | | - | (1) The license was obtained by false representations made in the application therefor; |
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346 | | - | (2) The pharmacy for which the license was issued was kept open for the transaction |
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347 | | - | of business without a pharmacist in charge thereof; |
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348 | | - | (3) Conviction of a violation of any law of this state or of the United States pertaining |
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349 | | - | to the drug business or for the aiding or abetting in the violation of the law; |
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350 | | - | (4) The active management of the pharmacy was changed without the transfer, as |
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351 | | - | provided in § 36-11-37, of the license; |
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352 | | - | (5) The location of the pharmacy was changed without the change being reported as |
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353 | | - | provided in § 36-11-39; |
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354 | | - | (6) The pharmacy was kept open for the transaction of business after the pharmacist |
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355 | | - | ceased to be in active management of the pharmacy; or |
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356 | | - | (7) The minimum requirements of this chapter and the board are no longer met. |
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357 | | - | A pharmacy license may not be suspended or revoked except by a vote of three or |
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358 | | - | more members of the board. |
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359 | | - | Section 30. That § 36-11-67 be AMENDED: 25.365.19 12 1016 |
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360 | | - | HB1016 ENROLLED |
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361 | | - | 36-11-67. A pharmacist or physician licensed under chapter 36-4 who participates |
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362 | | - | in a drug utilization review program is not individually or jointly subject to, and is immune |
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363 | | - | from, claim, suit, liability, damages, or any other recourse, civil or criminal, arising from |
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364 | | - | any act or proceeding, decision, or determination undertaken, performed, or reached in |
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365 | | - | good faith and without malice when acting individually or jointly in carrying out the |
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366 | | - | responsibilities, authority, duties, powers, and privileges of the program conferred upon |
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367 | | - | them under any provisions of law or rule, g ood faith being presumed until proven |
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368 | | - | otherwise, with malice required to be shown by the complainant. |
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369 | | - | For the purposes of this section, a "drug utilization review program" is a program |
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370 | | - | operated solely or partially as a professional standards review organization whose purpose |
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371 | | - | is to: |
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372 | | - | (1) Educate pharmacists and practitioners on: |
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373 | | - | (a) Severe adverse reactions to drugs; |
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374 | | - | (b) Therapeutic appropriateness; |
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375 | | - | (c) Overutilization; |
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376 | | - | (d) Underutilization; |
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377 | | - | (e) Appropriate use of generic products; |
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378 | | - | (f) Therapeutic duplication; |
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379 | | - | (g) Drug-disease contraindications; |
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380 | | - | (h) Drug-drug interactions; |
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381 | | - | (i) Incorrect drug dosage or duration of drug treatment; |
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382 | | - | (j) Drug-allergy interactions; and |
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383 | | - | (k) Clinical abuse or misuse; and |
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384 | | - | (2) Identify and reduce the frequency of patterns of potential and actual fraud, abuse, |
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385 | | - | gross overuse, inappropriate care, or medically unnecessary care associated with |
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386 | | - | specific drugs or groups of drugs among practitioners, pharmacists, and patients. |
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387 | | - | Section 31. That § 36-11-72 be AMENDED: |
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388 | | - | 36-11-72. The board shall promulgate rules pursuant to chapter 1-26 to provide |
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389 | | - | for the regulation of telepharmacy in this state. The rules must provide for: |
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390 | | - | (1) License and renewal application requirements, including: |
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391 | | - | (a) Establishment of an initial license fee and a renewal fee, each not to exceed |
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392 | | - | two hundred fifty dollars; |
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393 | | - | (b) Procedures for the reinstatement of an expired license; and 25.365.19 13 1016 |
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394 | | - | HB1016 ENROLLED |
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395 | | - | (c) Establishment of a late fee for reinstating an expired license, not to exceed |
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396 | | - | fifty dollars; |
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397 | | - | (2) Minimum structural, security, and equipment requirements for the remote |
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398 | | - | pharmacy; |
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399 | | - | (3) Minimum staffing requirements for the central pharmacy and remote pharmacy; |
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400 | | - | (4) Record keeping requirements for the central pharmacy and remote pharmacy; |
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401 | | - | (5) Policies and procedures for the daily operation of the remote pharmacy; and |
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402 | | - | (6) Use of automated dispensing machines. |
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403 | | - | Section 32. That a NEW SECTION be added to chapter 36-11: |
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404 | | - | If the majority of ownership of a remote pharmacy changes, the new owners must, |
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405 | | - | within thirty days after the ownership change: |
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406 | | - | (1) Submit the renewal application prescribed by the board, as provided in § 36-11- |
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407 | | - | 72, indicating the change of ownership; and |
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408 | | - | (2) Pay the renewal fee established by the board, as provided in § 36-11-72. |
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409 | | - | Section 33. That § 36-11A-8 be AMENDED: |
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410 | | - | 36-11A-8. To apply for a wholesale or other drug distributor license, a person |
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411 | | - | must submit an application on a form provided by the board and pay an annual license |
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412 | | - | fee set by the board, not to exceed five hundred dollars. |
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413 | | - | All financial statements or related information submitted by applicants must be |
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414 | | - | treated as confidential materials. |
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415 | | - | Section 34. That § 36-11A-13 be AMENDED: |
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416 | | - | 36-11A-13. Each wholesale drug distributor license expires on December thirty- |
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417 | | - | first following the date of issuance. The board shall provide an application for license |
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418 | | - | renewal to each licensee before December first of each year. To renew a license, the |
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419 | | - | licensee shall submit the renewal application and pay the annual license fee set by the |
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420 | | - | board as provided in § 36-11A-8. If application for renewal of the license accompanied by |
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421 | | - | the annual license fee is not made before the expiration date, the existing license lapses |
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422 | | - | on the date of expiration. If the board receives a renewal application and fee for an expired |
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423 | | - | license, the board must assess a fifty-dollar late fee and may reinstate the license. |
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424 | | - | If the majority of ownership of a licensed facility changes, the new owners must, |
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425 | | - | within thirty days after the ownership change: 25.365.19 14 1016 |
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426 | | - | HB1016 ENROLLED |
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427 | | - | (1) Submit a renewal application, indicating the change of ownership; and |
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428 | | - | (2) Pay a fee equal to the annual license fee. |
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429 | | - | Section 35. That § 36-11-3 be REPEALED. |
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430 | | - | Section 36. That § 36-11-6 be REPEALED. |
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431 | | - | Section 37. That § 36-11-17 be REPEALED. |
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432 | | - | Section 38. That § 36-11-18 be REPEALED. |
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433 | | - | Section 39. That § 36-11-22 be REPEALED. |
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434 | | - | Section 40. That § 36-11-28 be REPEALED. |
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435 | | - | Section 41. That § 36-11-29 be REPEALED. |
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436 | | - | Section 42. That § 36-11-40 be REPEALED. |
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437 | | - | Section 43. That § 36-11-42 be REPEALED. |
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438 | | - | Section 44. That § 36-11-49 be REPEALED. |
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439 | | - | Section 45. That § 36-11A-4.2 be REPEALED. |
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440 | | - | Section 46. No later than September 30, 2025, the Board of Pharmacy shall, pursuant to |
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441 | | - | chapter 1-26, provide for and file with the secretary of state, the amendment of ARSD |
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442 | | - | 20:67:02:01, as set forth below: |
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443 | | - | 20:67:02:01. Application and fee. A wholesale or other distributor must |
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444 | | - | apply each year to the board, electronically or on a form supplied by the board, for a |
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445 | | - | license to engage in the distribution of prescription drugs. Each application must be |
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446 | | - | accompanied by a license fee of five hundred dollars. |
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447 | | - | Source: 18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May |
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448 | | - | 26, 1998; 45 SDR 86, effective December 24, 2018. |
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449 | | - | General Authority: SDCL 36-11A-14. |
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450 | | - | Law Implemented: SDCL 36-11A-7, 36-11A-8. 25.365.19 15 1016 |
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451 | | - | HB1016 ENROLLED |
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452 | | - | An Act to revise provisions related to pharmacy and to increase fees. |
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453 | | - | |
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454 | | - | |
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455 | | - | |
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456 | | - | |
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457 | | - | I certify that the attached Act originated in |
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458 | | - | the: |
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459 | | - | |
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460 | | - | House as Bill No. 1016 |
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461 | | - | |
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462 | | - | |
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463 | | - | |
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464 | | - | Chief Clerk |
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465 | | - | |
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466 | | - | |
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467 | | - | |
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468 | | - | |
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469 | | - | Speaker of the House |
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470 | | - | |
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471 | | - | Attest: |
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472 | | - | |
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473 | | - | |
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474 | | - | |
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475 | | - | |
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476 | | - | Chief Clerk |
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477 | | - | |
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478 | | - | |
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479 | | - | |
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480 | | - | |
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481 | | - | President of the Senate |
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482 | | - | |
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483 | | - | Attest: |
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| 6 | + | SENATE ENGROSSED |
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491 | | - | |
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492 | | - | |
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493 | | - | House Bill No. 1016 |
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494 | | - | File No. ____ |
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495 | | - | Chapter No. ______ |
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496 | | - | |
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497 | | - | |
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498 | | - | |
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499 | | - | Received at this Executive Office |
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500 | | - | this _____ day of _____________, |
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501 | | - | |
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502 | | - | 2025 at ____________M. |
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503 | | - | |
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504 | | - | |
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505 | | - | |
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506 | | - | By |
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507 | | - | for the Governor |
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508 | | - | |
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509 | | - | |
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510 | | - | The attached Act is hereby |
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511 | | - | approved this ________ day of |
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512 | | - | ______________, A.D., 2025 |
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513 | | - | |
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514 | | - | |
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515 | | - | |
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516 | | - | |
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517 | | - | |
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518 | | - | Governor |
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519 | | - | |
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520 | | - | STATE OF SOUTH DAKOTA , |
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521 | | - | ss. |
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522 | | - | Office of the Secretary of State |
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523 | | - | |
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524 | | - | |
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525 | | - | Filed ____________, 2025 |
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526 | | - | at _________ o'clock __M. |
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527 | | - | |
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528 | | - | |
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529 | | - | |
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530 | | - | |
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531 | | - | |
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532 | | - | Secretary of State |
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533 | | - | |
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534 | | - | |
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535 | | - | |
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536 | | - | By |
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537 | | - | Asst. Secretary of State |
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538 | | - | |
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539 | | - | |
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| 15 | + | Underscores indicate new language. |
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| 16 | + | Overstrikes indicate deleted language. |
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| 17 | + | An Act to revise provisions related to pharmacy and to increase fees. 1 |
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| 18 | + | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: 2 |
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| 19 | + | Section 1. That § 13-33A-4 be AMENDED: 3 |
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| 20 | + | 13-33A-4. Any school may acquire and maintain a stock of epinephrine auto -4 |
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| 21 | + | injectors pursuant to a prescription issued by an authorized health care provider for use 5 |
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| 22 | + | in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions 6 |
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| 23 | + | of this section are not subject to the prescription requirements in subdivision 36-11-2(21) 7 |
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| 24 | + | chapter 36-11. 8 |
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| 25 | + | Section 2. That § 36-11-2 be AMENDED: 9 |
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| 26 | + | 36-11-2. Terms used in this chapter mean: 10 |
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| 27 | + | (1) "Association," the South Dakota Pharmacists Association; 11 |
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| 28 | + | (2) "Biological product," as defined in 42 U.S.C. § 262(i), as of (January 1, 2018); 12 |
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| 29 | + | (3)(2) "Board," or "board of pharmacy," the State Board of Pharmacy in South Dakota; 13 |
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| 30 | + | (4)(3) "Brand name," the proprietary or registered trademark name given to a drug 14 |
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| 31 | + | product by its manufacturer, labeler, or distributor and placed on the drug or on 15 |
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| 32 | + | its container, label, or wrapping at the time of packaging; 16 |
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| 33 | + | (5) "Chemicals," the chemical materials or medicine; 17 |
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| 34 | + | (6)(4) "Compounding," the preparation, mixing, assembling, packaging , or labeling of a 18 |
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| 35 | + | drug or drug device as the result of a practitioner's prescription drug order or an 19 |
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| 36 | + | initiative based on the pharmacist/patient/practitioner relationship in the course of 20 |
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| 37 | + | professional practice or for the purpose of or as an incident to research, teaching, 21 |
---|
| 38 | + | or chemical analysis and not for sale or dispensing. The term also includes the 22 |
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| 39 | + | preparation of drug or drug devices in anticipation of prescription drug orders based 23 |
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| 40 | + | on routine, regularly observed prescribing patterns; 24 25.365.18 2 1016 |
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| 41 | + | Underscores indicate new language. |
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| 42 | + | Overstrikes indicate deleted language. |
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| 43 | + | (7)(5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device 1 |
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| 44 | + | from one person to another, whether or not for a consideration; 2 |
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| 45 | + | (8)(6) "Dispense" or "Dispensing," the preparation and delivery of a drug to a patient or 3 |
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| 46 | + | a patient's agent pursuant to a prescription drug order in a suitable container with 4 |
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| 47 | + | appropriate labeling for subsequent administration to or use by a patient. The term 5 |
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| 48 | + | includes preparation of labels for drug devices if the labeling is related to the 6 |
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| 49 | + | dosage and administration of drugs; 7 |
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| 50 | + | (9)(7) "Distributing," the delivery of a drug or drug device other than by administration 8 |
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| 51 | + | or dispensing; 9 |
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| 52 | + | (10)(8) "Drug administration," the direct application of a drug or drug device by 10 |
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| 53 | + | injection, inhalation, ingestion, or any other means to the body of a patient or 11 |
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| 54 | + | research subject; 12 |
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| 55 | + | (11)(9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, 13 |
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| 56 | + | or other product used in combination with a drug to provide effective management 14 |
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| 57 | + | of medication regimens; 15 |
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| 58 | + | (12) "Drug utilization review program," any program operated solely or partially as a 16 |
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| 59 | + | professional standards review organization whose purpose is to educate 17 |
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| 60 | + | pharmacists and practitioners on severe adverse reactions to drugs, therapeutic 18 |
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| 61 | + | appropriateness, overutilization and underutilization, appropriate use of generic 19 |
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| 62 | + | products, therapeutic duplication, drug-disease contraindications, drug-drug 20 |
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| 63 | + | interactions, incorrect drug dosage or duration of drug treatment, drug -allergy 21 |
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| 64 | + | interactions and clinical abuse or misuse, as well as to identify and reduce the 22 |
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| 65 | + | frequency of patterns of potential and actual fraud, abuse, gross overuse, 23 |
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| 66 | + | inappropriate care or medically unnecessary care associated with specific drugs or 24 |
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| 67 | + | groups of drugs among practitioners, pharmacists and patients; 25 |
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| 68 | + | (13)(10) "Equivalent drug product," a drug product, other than a biological product, that 26 |
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| 69 | + | is considered to be therapeutically equivalent to other pharmaceutically equivalent 27 |
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| 70 | + | products as determined by the latest edition of Approved Drug Products with 28 |
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| 71 | + | Therapeutic Equivalence Evaluations, as adopted by the board through rules 29 |
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| 72 | + | promulgated pursuant to chapter 1-26; 30 |
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| 73 | + | (14)(11) "Interchangeable biological product," a biological product that the U.S. United 31 |
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| 74 | + | States Food and Drug Administration either has licensed and determined meets the 32 |
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| 75 | + | standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), as of (January 33 |
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| 76 | + | 1, 2018), or has determined is therapeutically equivalent, as set forth in the latest 34 |
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| 77 | + | edition of, or any supplement to, the Food and Drug Administration's Approved 35 25.365.18 3 1016 |
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| 78 | + | Underscores indicate new language. |
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| 79 | + | Overstrikes indicate deleted language. |
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| 80 | + | Drug Products with Therapeutic Equivalence Evaluations publication as adopted by 1 |
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| 81 | + | the board through rules promulgated pursuant to chapter 1-26; 2 |
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| 82 | + | (15)(12) "Labeling," the process of preparing and affixing a label to any drug or drug 3 |
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| 83 | + | device container exclusive of the labeling by the manufacturer, packer , or 4 |
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| 84 | + | distributor of a nonprescription drug or commercially packaged legend drug or drug 5 |
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| 85 | + | device; 6 |
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| 86 | + | (16) "Medical device," an instrument, apparatus, implement, machine, contrivance, 7 |
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| 87 | + | implant, in vitro reagent or other similar or related article, including any 8 |
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| 88 | + | component, part or accessory, that is intended for use in the diagnosis of disease 9 |
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| 89 | + | or other conditions or in the cure, mitigation, treatment or prevention of disease 10 |
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| 90 | + | in man or other animals or is intended to affect the structure or any function of the 11 |
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| 91 | + | body of man or other animals, that does not achieve any of its principal intended 12 |
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| 92 | + | purposes through chemical action within or on the body of man or other animals 13 |
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| 93 | + | and that is not dependent upon being metabolized for achievement of any of its 14 |
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| 94 | + | principal intended purposes; 15 |
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| 95 | + | (17)(13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the 16 |
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| 96 | + | prevention, relief, or cure of diseases when used either internally or externally by 17 |
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| 97 | + | man or for animals; 18 |
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| 98 | + | (18)(14) "Nonprescription drugs," drugs that are labeled for use by the general public in 19 |
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| 99 | + | accordance with § 502 of the Federal Food, Drug and Cosmetic Act as amended 20 |
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| 100 | + | through January 1, 1997, 21 U.S.C. § 352 (January 1, 2025), and may be sold 21 |
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| 101 | + | without a prescription drug order in accordance with § 503 of the Federal Food, 22 |
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| 102 | + | Drug and Cosmetic Act as amended through January 1, 1997 21 U.S.C. § 353 23 |
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| 103 | + | (January 1, 2025). The term does not include drugs which that are required by 24 |
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| 104 | + | federal law to bear the statement, "Caution: federal law prohibits dispensing 25 |
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| 105 | + | without prescription," drugs intended for human use by hypodermic injection, or 26 |
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| 106 | + | animal remedies regulated by chapter 39-18; 27 |
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| 107 | + | (19)(15) "Patient counseling," oral communication by the pharmacist of information to 28 |
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| 108 | + | the patient or caregiver, as defined in rules promulgated pursuant to chapter 1-26, 29 |
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| 109 | + | to improve therapy by ensuring proper use of drugs and drug devices; 30 |
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| 110 | + | (20)(16) "Pharmaceutical care," provision of drug therapy and other pharmaceutical 31 |
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| 111 | + | patient care services intended to achieve outcomes related to cure curing or 32 |
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| 112 | + | prevention of preventing a disease, elimination eliminating or reduction of reducing 33 |
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| 113 | + | a patient's symptoms, or arresting or slowing of a disease process; 34 25.365.18 4 1016 |
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| 114 | + | Underscores indicate new language. |
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| 115 | + | Overstrikes indicate deleted language. |
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| 116 | + | (21)(17) "Pharmacist," a person licensed by the board to engage in the practice of 1 |
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| 117 | + | pharmacy; 2 |
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| 118 | + | (22)(18) "Pharmacy," any place of business within or outside this state licensed by the 3 |
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| 119 | + | board where drugs are dispensed and pharmaceutical care is provided to residents 4 |
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| 120 | + | of this state; 5 |
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| 121 | + | (23)(19) "Practitioner," a person licensed, registered, or otherwise authorized by the 6 |
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| 122 | + | jurisdiction in which the person is practicing to prescribe drugs in the course of 7 |
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| 123 | + | professional practice; 8 |
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| 124 | + | (24)(20) "Prescription drug order," a written or oral order of a practitioner for a drug or 9 |
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| 125 | + | drug device for a specific patient; 10 |
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| 126 | + | (25)(21) "Proper name," the nonproprietary name for a biological product designated by 11 |
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| 127 | + | the U.S. United States Food and Drug Administration license for use upon each 12 |
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| 128 | + | package of the product; and 13 |
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| 129 | + | (26)(22) "Registered pharmacy technician," a person registered by the board who is 14 |
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| 130 | + | employed by a pharmacy to assist licensed pharmacists in the practice of pharmacy 15 |
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| 131 | + | by performing specific tasks delegated by and under the immediate personal 16 |
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| 132 | + | supervision and control of a licensed pharmacist, as permitted by the board; 17 |
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| 133 | + | (27) "Retail place of business," any place where merchandise is sold at retail and from 18 |
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| 134 | + | which original packages of nonprescription drugs are sold or taken to be sold at 19 |
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| 135 | + | retail; 20 |
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| 136 | + | (28) "Reverse distributor," any person or business registered with the Drug Enforcement 21 |
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| 137 | + | Administration that accepts drug products from vendors and returns the drug 22 |
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| 138 | + | products to manufacturers for credit or destruction. 23 |
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| 139 | + | Section 3. That § 36-11-2.1 be AMENDED: 24 |
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| 140 | + | 36-11-2.1. Drugs For the purpose of this chapter, "drugs" are defined as follows: 25 |
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| 141 | + | (1) Articles recognized in the official United States Pharmacopoeia or the official 26 |
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| 142 | + | National Formulary, as adopted by the board of pharmacy through rules 27 |
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| 143 | + | promulgated pursuant to chapter 1-26, or recognized in the official Homeopathic 28 |
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| 144 | + | Pharmacopoeia of the United States as in effect on January 1, 1993; 29 |
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| 145 | + | (2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention 30 |
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| 146 | + | of disease in humans or other animals; 31 |
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| 147 | + | (3) Articles (, other than food), intended to affect the structure or any functions of the 32 |
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| 148 | + | human body; and 33 |
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| 149 | + | (4) Articles intended for use as a component of any articles specified in this section. 34 25.365.18 5 1016 |
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| 150 | + | Underscores indicate new language. |
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| 151 | + | Overstrikes indicate deleted language. |
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| 152 | + | The term "drugs" excludes medical devices. 1 |
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| 153 | + | For the purposes of this section, "medical device" means an instrument, apparatus, 2 |
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| 154 | + | implement, machine, contrivance, implant, in vitro reagent, or other similar or related 3 |
---|
| 155 | + | article, including any component, part, or accessory, that is intended for use in the 4 |
---|
| 156 | + | diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention 5 |
---|
| 157 | + | of disease in humans or animals, or is intended to affect the structure or any function of 6 |
---|
| 158 | + | the body of humans or animals, that does not achieve any of its principal intended 7 |
---|
| 159 | + | purposes through chemical action within or on the body of humans or animals and that is 8 |
---|
| 160 | + | not dependent upon being metabolized for achievement of any of its principal intended 9 |
---|
| 161 | + | purposes. 10 |
---|
| 162 | + | Section 4. That § 36-11-5 be AMENDED: 11 |
---|
| 163 | + | 36-11-5. The Board of Pharmacy board shall hold meetings for the examination of 12 |
---|
| 164 | + | applicants for licensure and registration, and the transaction of such other business as 13 |
---|
| 165 | + | shall pertain that pertains to its duties. Special meetings of the board may be held 14 |
---|
| 166 | + | whenever it shall be deemed necessary by a majority of the members thereof board. Two 15 |
---|
| 167 | + | Three members of such the board shall constitute constitutes a quorum. 16 |
---|
| 168 | + | Section 5. That § 36-11-13 be AMENDED: 17 |
---|
| 169 | + | 36-11-13. It is a Class 2 misdemeanor for any person other than a pharmacist 18 |
---|
| 170 | + | registered under the laws of South Dakota to engage in the practice of pharmacy, except 19 |
---|
| 171 | + | as provided by § 36-11-14. 20 |
---|
| 172 | + | Section 6. That § 36-11-15 be AMENDED: 21 |
---|
| 173 | + | 36-11-15. Any person, other than a registered pharmacist, who compounds or 22 |
---|
| 174 | + | dispenses drugs, medicines, or poisons, or who keeps a pharmacy or store for retailing or 23 |
---|
| 175 | + | compounding medicines, or who takes, uses , or exhibits the title of a registered 24 |
---|
| 176 | + | pharmacist, is guilty of a Class 2 misdemeanor. 25 |
---|
| 177 | + | Section 7. That § 36-11-16 be AMENDED: 26 |
---|
| 178 | + | 36-11-16. Any person of The board shall issue a license to practice pharmacy to 27 |
---|
| 179 | + | an individual who: 28 |
---|
| 180 | + | (1) Submits an application prescribed by the board; 29 25.365.18 6 1016 |
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| 181 | + | Underscores indicate new language. |
---|
| 182 | + | Overstrikes indicate deleted language. |
---|
| 183 | + | (2) Submits an application fee set by the board through rules promulgated in 1 |
---|
| 184 | + | accordance with chapter 1-26, but not exceeding thirty-five dollars; 2 |
---|
| 185 | + | (3) Is of good moral character and temperate habits,; 3 |
---|
| 186 | + | (4) Is not less than eighteen years of age, who is; 4 |
---|
| 187 | + | (5) Is a graduate of a college of pharmacy recognized and approved by the board, and 5 |
---|
| 188 | + | who has ; 6 |
---|
| 189 | + | (6) Has had the necessary experience as determined by the board in the practice of 7 |
---|
| 190 | + | pharmacy under a regularly licensed pharmacist in a pharmacy where physicians' 8 |
---|
| 191 | + | prescriptions are compounded and who shall pass a satisfactory; and 9 |
---|
| 192 | + | (7) Has passed an examination prescribed by the State Board of Pharmacy, shall be 10 |
---|
| 193 | + | entitled to a certificate of registration as a licensed pharmacist board. 11 |
---|
| 194 | + | The board shall have the authority to may allow credit for suitable military and 12 |
---|
| 195 | + | research activities in the field of pharmacy as part of the experience requirement. 13 |
---|
| 196 | + | Section 8. That § 36-11-19 be AMENDED: 14 |
---|
| 197 | + | 36-11-19. The Board of Pharmacy board may in its discretion grant certificates of 15 |
---|
| 198 | + | registration to such persons as shall furnish with their applications issue a license to 16 |
---|
| 199 | + | practice pharmacy to individual who applies to the board and submits satisfactory proof 17 |
---|
| 200 | + | that they have the individual has been registered licensed by examination in some other 18 |
---|
| 201 | + | another state;, provided that such the other state required a degree of competency at the 19 |
---|
| 202 | + | time such person the individual was licensed at least equal to that required of licentiates 20 |
---|
| 203 | + | in this state at that same time. 21 |
---|
| 204 | + | The State Board of Pharmacy, in order to be informed, board may, in determining 22 |
---|
| 205 | + | the degree of fitness required by the several other states' boards of pharmacy for granting 23 |
---|
| 206 | + | license and reciprocal registration licensure, join with other states' boards of pharmacy. 24 |
---|
| 207 | + | Every person individual applying for registration licensure pursuant to this section shall 25 |
---|
| 208 | + | pay to the board upon an application a fee, not to exceed one hundred fifty dollars, set by 26 |
---|
| 209 | + | the board by rule promulgated pursuant to chapter 1-26. 27 |
---|
| 210 | + | Section 9. That § 36-11-19.1 be AMENDED: 28 |
---|
| 211 | + | 36-11-19.1. Registered pharmacists A pharmacist may: 29 |
---|
| 212 | + | (1) Perform drug administration pursuant to a prescription drug order. The Board of 30 |
---|
| 213 | + | Pharmacy shall establish standards for drug administration pursuant to chapter 1-31 |
---|
| 214 | + | 26 with the approval of a committee composed of two persons appointed by the 32 25.365.18 7 1016 |
---|
| 215 | + | Underscores indicate new language. |
---|
| 216 | + | Overstrikes indicate deleted language. |
---|
| 217 | + | Board of Pharmacy, two persons appointed by the Board of Nursing and two 1 |
---|
| 218 | + | persons appointed by the Board of Medical and Osteopathic Examiners ; 2 |
---|
| 219 | + | (2) Perform drug reviews; 3 |
---|
| 220 | + | (3) Perform or participate in scientific or clinical drug or drug-related research as an 4 |
---|
| 221 | + | investigator or in collaboration with other investigators; 5 |
---|
| 222 | + | (4) Interpret and apply pharmacokinetic data and other pertinent laboratory data to 6 |
---|
| 223 | + | design safe and effective drug dosage regimens; 7 |
---|
| 224 | + | (5) Participate in drug and drug device selection pursuant to a prescription drug order; 8 |
---|
| 225 | + | (6) Initiate or modify drug therapy by protocol or other legal authority established and 9 |
---|
| 226 | + | approved within a licensed health care facility or by a practitioner authorized to 10 |
---|
| 227 | + | prescribe drugs; and 11 |
---|
| 228 | + | (7) Provide information on prescription drugs, which may include advising, consulting, 12 |
---|
| 229 | + | and educating, as necessary or as required, patients, the public, and other health 13 |
---|
| 230 | + | care providers on the rational, safe and cost-effective use of drugs, including 14 |
---|
| 231 | + | therapeutic values, content, hazards and appropriate use. 15 |
---|
| 232 | + | The board shall establish standards for drug administration, in rules promulgated 16 |
---|
| 233 | + | pursuant to chapter 1-26, with the approval of a committee composed of two persons 17 |
---|
| 234 | + | appointed by the board, two persons appointed by the South Dakota Board of Nursing, 18 |
---|
| 235 | + | and two persons appointed by the State Board of Medical and Osteopathic Examiners. 19 |
---|
| 236 | + | Section 10. That § 36-11-19.5 be AMENDED: 20 |
---|
| 237 | + | 36-11-19.5. Each nonresident pharmacy license expires on June thirtieth following 21 |
---|
| 238 | + | the date of issue issuance. The board shall mail an provide a renewal application for license 22 |
---|
| 239 | + | renewal to each licensee before June first of each year. If the licensee does not submit a 23 |
---|
| 240 | + | renewal application for renewal of the license, accompanied by the annual license the 24 |
---|
| 241 | + | renewal fee is not made, before the expiration date, the existing license lapses on the 25 |
---|
| 242 | + | date of expiration. The board shall promulgate rules, pursuant to chapter 1-26, to establish 26 |
---|
| 243 | + | the renewal fee, which may not exceed two hundred dollars. If the renewal application is 27 |
---|
| 244 | + | submitted after the expiration of the license, the board must assess a fifty-dollar late fee 28 |
---|
| 245 | + | and may reinstate the license. 29 |
---|
| 246 | + | If a majority of ownership of a licensed nonresident pharmacy changes, the new 30 |
---|
| 247 | + | owners must, within thirty days after the ownership change: 31 |
---|
| 248 | + | (1) Submit the renewal application, indicating the change of ownership; and 32 |
---|
| 249 | + | (2) Pay the renewal fee established by the board as provided in this section. 33 25.365.18 8 1016 |
---|
| 250 | + | Underscores indicate new language. |
---|
| 251 | + | Overstrikes indicate deleted language. |
---|
| 252 | + | Section 11. That § 36-11-19.6 be AMENDED: 1 |
---|
| 253 | + | 36-11-19.6. The board may deny, revoke, or suspend a nonresident pharmacy 2 |
---|
| 254 | + | registration license for conduct which that causes serious bodily injury or serious 3 |
---|
| 255 | + | psychological injury to a resident of this state, if the board has referred the matter to the 4 |
---|
| 256 | + | regulatory or licensing agency in the state in which the nonresident pharmacy is located 5 |
---|
| 257 | + | and the regulatory or licensing agency fails to initiate an investigation within forty-five 6 |
---|
| 258 | + | days after the referral. 7 |
---|
| 259 | + | Any action taken to deny, revoke, or suspend a nonresident pharmacy registration 8 |
---|
| 260 | + | license is a contested case proceeding pursuant to chapter 1-26. 9 |
---|
| 261 | + | Section 12. That § 36-11-20 be AMENDED: 10 |
---|
| 262 | + | 36-11-20. The Board of Pharmacy board may, in compliance with chapter 1-26, 11 |
---|
| 263 | + | suspend, revoke, or refuse to grant issue or renew a license or certificate of registration 12 |
---|
| 264 | + | to practice pharmacy to any person who: 13 |
---|
| 265 | + | (1) Is guilty of a felony or a misdemeanor involving moral turpitude, or who is; 14 |
---|
| 266 | + | (2) Is addicted to the use of alcoholic liquors or narcotic drugs to such an extent as to 15 |
---|
| 267 | + | render him the person unfit to practice pharmacy with reasonable skill and safety; 16 |
---|
| 268 | + | and the board may, in compliance with chapter 1-26, revoke a license for like 17 |
---|
| 269 | + | cause, or any license which has been procured 18 |
---|
| 270 | + | (3) Procured a license by fraud or by false representation. Any license or registration, 19 |
---|
| 271 | + | or renewal thereof, obtained through fraud or by any fraudulent or false 20 |
---|
| 272 | + | representations shall be void. The board may suspend, revoke or refuse to grant a 21 |
---|
| 273 | + | license or certificate of registration to any person; 22 |
---|
| 274 | + | (4) Is permitting or engaging in the unauthorized sale of legend or controlled drugs or 23 |
---|
| 275 | + | substances or who the; or 24 |
---|
| 276 | + | (5) The board finds to be in violation of any law, rule, or regulation governing 25 |
---|
| 277 | + | pharmacists. 26 |
---|
| 278 | + | Section 13. That § 36-11-23 be AMENDED: 27 |
---|
| 279 | + | 36-11-23. Each To renew a license to practice pharmacy, a pharmacist shall must 28 |
---|
| 280 | + | annually by October first, on or before September thirtieth of each year, submit a renewal 29 |
---|
| 281 | + | application and pay to the board a registry renewal fee to be fixed set by the board in 30 |
---|
| 282 | + | compliance rules promulgated in accordance with chapter 1-26, not to exceed one hundred 31 |
---|
| 283 | + | fifty dollars. Upon application and payment of the fee by a pharmacist, the Board of 32 25.365.18 9 1016 |
---|
| 284 | + | Underscores indicate new language. |
---|
| 285 | + | Overstrikes indicate deleted language. |
---|
| 286 | + | Pharmacy, the board shall renew the pharmacist's certificate of registration. Any license. 1 |
---|
| 287 | + | If a pharmacist who fails to apply and pay the renewal fee by the due date is subject to 2 |
---|
| 288 | + | suspension of certificate by the board in compliance with chapter 1-26. Any suspended 3 |
---|
| 289 | + | certificate may be reinstated, the license expires. 4 |
---|
| 290 | + | The board may reinstate an expired license if the individual: 5 |
---|
| 291 | + | (1) Applies for reinstatement; and 6 |
---|
| 292 | + | (2) Pays all delinquent fees have been paid, plus a penalty of twenty- five dollars, and 7 |
---|
| 293 | + | the Board of Pharmacy has approved the application for reinstatement, plus a fifty-8 |
---|
| 294 | + | dollar late fee. 9 |
---|
| 295 | + | Section 14. That § 36-11-25 be AMENDED: 10 |
---|
| 296 | + | 36-11-25. Pharmacy The board may issue a pharmacy intern certificates may be 11 |
---|
| 297 | + | issued by the Board of Pharmacy certificate to persons an individual who are is gaining 12 |
---|
| 298 | + | experience as a qualification for licensure as a registered pharmacist. Any pharmacy intern 13 |
---|
| 299 | + | granted issued an intern certificate shall perform his the internship pursuant to regulations 14 |
---|
| 300 | + | which shall be rules promulgated by the Board of Pharmacy board in accordance with 15 |
---|
| 301 | + | chapter 1-26. Nothing in this section shall may be construed as giving such a pharmacy 16 |
---|
| 302 | + | intern authority to fill any prescription, except under the supervision and in the presence 17 |
---|
| 303 | + | of the registered pharmacist. 18 |
---|
| 304 | + | Section 15. That § 36-11-26 be AMENDED: 19 |
---|
| 305 | + | 36-11-26. If the Board of Pharmacy board is satisfied that any person holding a 20 |
---|
| 306 | + | certificate of registration pharmacist is for any reason incompetent or disqualified to 21 |
---|
| 307 | + | perform the duties of a registered pharmacist pursuant to § 36-11-20 or as contemplated 22 |
---|
| 308 | + | by the provisions of this chapter, it may, in compliance with § 36-11-28 chapter 1-26: 23 |
---|
| 309 | + | (1) Issue a reprimand to the registrant pharmacist; 24 |
---|
| 310 | + | (2) Place the registrant pharmacist on probation and supervision; 25 |
---|
| 311 | + | (3) Suspend the registrant's certificate pharmacist's license until he the pharmacist 26 |
---|
| 312 | + | completes a course of therapy, treatment, training, or any combination thereof; 27 |
---|
| 313 | + | (4) Suspend the registrant's certificate pharmacist's license for a fixed period; and 28 |
---|
| 314 | + | (5) Revoke the registrant's certificate pharmacist's license. 29 |
---|
| 315 | + | An individual may appeal a decision of the board as provided in chapter 1-26. 30 |
---|
| 316 | + | Section 16. That § 36-11-30 be AMENDED: 31 25.365.18 10 1016 |
---|
| 317 | + | Underscores indicate new language. |
---|
| 318 | + | Overstrikes indicate deleted language. |
---|
| 319 | + | 36-11-30. No A person may not open or operate a pharmacy shall open or be kept 1 |
---|
| 320 | + | open for transaction of business until it has been registered and a permit issued unless 2 |
---|
| 321 | + | the pharmacy is licensed by the State Board of Pharmacy board. 3 |
---|
| 322 | + | A violation of this section is a Class 2 misdemeanor. Each day of violation is a 4 |
---|
| 323 | + | separate offense. 5 |
---|
| 324 | + | Section 17. That § 36-11-31 be AMENDED: 6 |
---|
| 325 | + | 36-11-31. No Only a person, copartnership or corporation that has a pharmacy 7 |
---|
| 326 | + | license issued by the board may carry: 8 |
---|
| 327 | + | (1) Carry on, conduct, or transact business under a name which that contains as a part 9 |
---|
| 328 | + | thereof the term or words "drug department," "drugstore," or "pharmacy," or any 10 |
---|
| 329 | + | term implying the operation of a pharmacy or drugstore, or in any manner by 11 |
---|
| 330 | + | advertisement, circular, poster, sign or otherwise describe; and 12 |
---|
| 331 | + | (2) Advertise, describe, or refer to a place of business, in any manner, by the terms 13 |
---|
| 332 | + | "drugstore" or "pharmacy," or any other term or words which may be applied to 14 |
---|
| 333 | + | establishments where drugs, medicines, and poisons are usually dispensed or 15 |
---|
| 334 | + | distributed, unless the place of business so conducted is a pharmacy duly 16 |
---|
| 335 | + | authorized and registered by the State Board of Pharmacy implying the operation 17 |
---|
| 336 | + | of a pharmacy. 18 |
---|
| 337 | + | A violation of this section is a Class 2 misdemeanor. 19 |
---|
| 338 | + | Section 18. That § 36-11-32 be AMENDED: 20 |
---|
| 339 | + | 36-11-32. Upon The board shall issue a pharmacy license to a pharmacist in good 21 |
---|
| 340 | + | standing, if the pharmacist: 22 |
---|
| 341 | + | (1) Submits a form prescribed by the State Board of Pharmacy board; and the payment 23 |
---|
| 342 | + | of 24 |
---|
| 343 | + | (2) Pays a fee, not to exceed two hundred dollars, set by the Board of Pharmacy board 25 |
---|
| 344 | + | in rules promulgated in accordance with chapter 1-26, the State Board of Pharmacy 26 |
---|
| 345 | + | shall issue to pharmacists in good standing, registered under the laws of this state, 27 |
---|
| 346 | + | a permit to conduct a pharmacy. 28 |
---|
| 347 | + | Section 19. That § 36-11-33 be AMENDED: 29 |
---|
| 348 | + | 36-11-33. The Board of Pharmacy board may issue to pharmacists a pharmacist 30 |
---|
| 349 | + | in good standing a permit license to conduct operate a part-time, limited, or conditional 31 25.365.18 11 1016 |
---|
| 350 | + | Underscores indicate new language. |
---|
| 351 | + | Overstrikes indicate deleted language. |
---|
| 352 | + | pharmacy in hospitals a hospital, nursing homes facility, or related facilities facility, 1 |
---|
| 353 | + | provided that the pharmacy services are limited to patients inpatients or residents of the 2 |
---|
| 354 | + | facility. 3 |
---|
| 355 | + | A permit to conduct a pharmacy, the The board may issue a license under this 4 |
---|
| 356 | + | section if: 5 |
---|
| 357 | + | (1) The pharmacist submits a form prescribed by the board and pays a fee, not to 6 |
---|
| 358 | + | exceed two hundred dollars, set by the board in rules promulgated in accordance 7 |
---|
| 359 | + | with chapter 1-26; and 8 |
---|
| 360 | + | (2) The merchandise and fixtures of which the pharmacy are owned by a person, firm, 9 |
---|
| 361 | + | or corporation other than a registered the pharmacist, upon said registered 10 |
---|
| 362 | + | pharmacist making application for a permit hereunder, may be issued and granted 11 |
---|
| 363 | + | to the said registered pharmacist, on compliance applying for the license. 12 |
---|
| 364 | + | The pharmacist must comply with the provisions of this chapter, and with minimum 13 |
---|
| 365 | + | standards as established by the board in rules promulgated pursuant to chapter 1-26. 14 |
---|
| 366 | + | Section 20. That § 36-11-34 be AMENDED: 15 |
---|
| 367 | + | 36-11-34. No permit to conduct The board may not issue a pharmacy shall be 16 |
---|
| 368 | + | issued license to any pharmacist applicant unless such pharmacist: 17 |
---|
| 369 | + | (1) The applicant is the owner, or part owner, of the merchandise and fixtures of the 18 |
---|
| 370 | + | place of business for which such the pharmacy registration license is applied for, 19 |
---|
| 371 | + | or unless; 20 |
---|
| 372 | + | (2) The application is made jointly with a registered pharmacist owner,; or unless the 21 |
---|
| 373 | + | (3) The nonpharmacist owner of the merchandise and fixtures of the place of business 22 |
---|
| 374 | + | for which the pharmacy registration license is applied for, has made submitted an 23 |
---|
| 375 | + | affidavit on a form prescribed by the state board of pharmacy delegating complete 24 |
---|
| 376 | + | responsibility for the pharmaceutical services in said place of business to the 25 |
---|
| 377 | + | pharmacist applicant. 26 |
---|
| 378 | + | Section 21. That § 36-11-35 be AMENDED: 27 |
---|
| 379 | + | 36-11-35. Each permit for a pharmacy shall constitute and signify a legal 28 |
---|
| 380 | + | registration for the pharmacy to which it applies, and shall expire pharmacy license expires 29 |
---|
| 381 | + | on the last day of June thirtieth following the date of issue. To renew a pharmacy license, 30 |
---|
| 382 | + | the pharmacist must submit a renewal application on or before June thirtieth on a form 31 |
---|
| 383 | + | prescribed by the board, and pay the renewal fee set by the board in rules promulgated 32 |
---|
| 384 | + | in accordance with chapter 1-26, but not exceeding two hundred dollars. If the renewal 33 25.365.18 12 1016 |
---|
| 385 | + | Underscores indicate new language. |
---|
| 386 | + | Overstrikes indicate deleted language. |
---|
| 387 | + | application and fee is submitted after the expiration of the license, the board must assess 1 |
---|
| 388 | + | a fifty-dollar late fee and may reinstate the license. 2 |
---|
| 389 | + | If a majority ownership of the pharmacy changes, the new owners must, within 3 |
---|
| 390 | + | thirty days after ownership change: 4 |
---|
| 391 | + | (1) Submit the renewal application, indicating the change of ownership; and 5 |
---|
| 392 | + | (2) Pay the renewal fee established by the board as provided in this section. 6 |
---|
| 393 | + | Section 22. That § 36-11-36 be AMENDED: 7 |
---|
| 394 | + | 36-11-36. Each permit for a pharmacy, together with a certificate naming the 8 |
---|
| 395 | + | pharmacist actively conducting said pharmacy, license issued by the State Board of 9 |
---|
| 396 | + | Pharmacy, which shall be a part of said permit, shall board must be exposed posted in a 10 |
---|
| 397 | + | conspicuous place in the pharmacy to which it applies that is viewable by the public. 11 |
---|
| 398 | + | Section 23. That § 36-11-37 be AMENDED: 12 |
---|
| 399 | + | 36-11-37. Each permit for a A pharmacy license may be transferred to another 13 |
---|
| 400 | + | pharmacist in good standing and registered under the laws of this state without the 14 |
---|
| 401 | + | payment of an additional fee;, provided an application for the transfer of said permit the 15 |
---|
| 402 | + | license is made upon a form prescribed by the State Board of Pharmacy board and upon 16 |
---|
| 403 | + | payment of a fifty dollar fee. The application for transfer must be filed with the secretary 17 |
---|
| 404 | + | thereof board not less more than ten days before after the transfer of such active 18 |
---|
| 405 | + | management is made. If the application for transfer is received by the board after ten 19 |
---|
| 406 | + | days, the pharmacy license is void, and the pharmacist must reapply for the license. 20 |
---|
| 407 | + | Section 24. That § 36-11-38 be AMENDED: 21 |
---|
| 408 | + | 36-11-38. In the event of the death of the pharmacist permittee in active 22 |
---|
| 409 | + | management, the pharmacy permit license issued to the deceased under this chapter 23 |
---|
| 410 | + | shall, within one hundred twenty days after the date of death of such permittee or on June 24 |
---|
| 411 | + | thirtieth, whichever is sooner, become null and void, unless transfer thereof, the license 25 |
---|
| 412 | + | is transferred as provided in § 36-11-37, shall have been made within the said one 26 |
---|
| 413 | + | hundred twenty day period. 27 |
---|
| 414 | + | Section 25. That § 36-11-39 be AMENDED: 28 |
---|
| 415 | + | 36-11-39. The change of location of any pharmacy for which a permit license has 29 |
---|
| 416 | + | been issued from one municipality to another within this state , any change in the 30 25.365.18 13 1016 |
---|
| 417 | + | Underscores indicate new language. |
---|
| 418 | + | Overstrikes indicate deleted language. |
---|
| 419 | + | ownership of such pharmacy, or the cessation of business by such the pharmacy shall, 1 |
---|
| 420 | + | must be reported to the State Board of Pharmacy board within ten days from such the 2 |
---|
| 421 | + | occurrence on forms prescribed by the State Board of Pharmacy board. 3 |
---|
| 422 | + | Section 26. That § 36-11-41 be AMENDED: 4 |
---|
| 423 | + | 36-11-41. No permit may be issued under 36-11-32 unlessA pharmacy licensed 5 |
---|
| 424 | + | by the board must: 6 |
---|
| 425 | + | (1) The pharmacy is Be equipped with the pharmaceutical instruments and utensils 7 |
---|
| 426 | + | prescribed by the State Board of Pharmacy, and shall possess board in rules 8 |
---|
| 427 | + | promulgated in accordance with chapter 1-26; 9 |
---|
| 428 | + | (2) Possess a stock of pharmaceuticals adequate to serve the needs of the community 10 |
---|
| 429 | + | in which the pharmacy is located; and 11 |
---|
| 430 | + | (2)(3) The pharmacy has Have on file at all times the publications and supplements of 12 |
---|
| 431 | + | formularies and drug information prescribed by the board, by rules promulgated 13 |
---|
| 432 | + | pursuant to chapter 1-26; and 14 |
---|
| 433 | + | (4) Be maintained and operated in a clean and sanitary condition, free from unhealth, 15 |
---|
| 434 | + | foreign, or injurious contamination. 16 |
---|
| 435 | + | Section 27. That § 36-11-43 be AMENDED: 17 |
---|
| 436 | + | 36-11-43. The Board of Pharmacy board may, in the manner provided by rules 18 |
---|
| 437 | + | promulgated in accordance with chapter 1-26, adopt a code of professional ethics for 19 |
---|
| 438 | + | pharmacists in this state in the practice of their profession. In adopting such code, or any 20 |
---|
| 439 | + | amendments thereafter, the. The board will shall consider the recommendations of the 21 |
---|
| 440 | + | South Dakota Pharmacists Association and the vote of its members, provided however, 22 |
---|
| 441 | + | that any such in adopting the code or changes made thereto. The code so adopted shall 23 |
---|
| 442 | + | at no time may not contain any provision that would in any way restrain, prohibit, or 24 |
---|
| 443 | + | attempt to regulate the rights of any pharmacist to be employed in any a licensed 25 |
---|
| 444 | + | pharmacy holding a valid pharmacy permit. Violation of the code of professional ethics 26 |
---|
| 445 | + | shall may not be the basis for criminal prosecution unless otherwise declared unlawful. 27 |
---|
| 446 | + | Section 28. That § 36-11-44 be AMENDED: 28 |
---|
| 447 | + | 36-11-44. Any registered pharmacist who permits the compounding or dispensing 29 |
---|
| 448 | + | of prescriptions or the vending of drugs or poisons in his store or in the pharmacist's place 30 |
---|
| 449 | + | of business, except under the personal supervision of a registered pharmacist, or any 31 25.365.18 14 1016 |
---|
| 450 | + | Underscores indicate new language. |
---|
| 451 | + | Overstrikes indicate deleted language. |
---|
| 452 | + | pharmacist who, while continuing in business, makes any false representations to procure 1 |
---|
| 453 | + | registration for himself a license for the pharmacist or any other person, is guilty of a 2 |
---|
| 454 | + | Class 2 misdemeanor. 3 |
---|
| 455 | + | Section 29. That § 36-11-48 be AMENDED: 4 |
---|
| 456 | + | 36-11-48. The State Board of Pharmacy board may suspend or revoke , in 5 |
---|
| 457 | + | accordance with chapter 1-26, any permit obtained pharmacy license issued under this 6 |
---|
| 458 | + | chapter on the following grounds: 7 |
---|
| 459 | + | (1) The license was obtained by false representations made in the application therefor, 8 |
---|
| 460 | + | or when the; 9 |
---|
| 461 | + | (2) The pharmacy for which the permit shall be license was issued is was kept open 10 |
---|
| 462 | + | for the transaction of business without a registered pharmacist in charge thereof, 11 |
---|
| 463 | + | or upon conviction; 12 |
---|
| 464 | + | (3) Conviction of a violation of any law of this state or of the United States pertaining 13 |
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| 465 | + | to the drug business or for the aiding or abetting in the violation of any such the 14 |
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| 466 | + | law; 15 |
---|
| 467 | + | (4) The active management of the pharmacy was changed without the transfer, as 16 |
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| 468 | + | provided in § 36-11-37, of the license; 17 |
---|
| 469 | + | (5) The location of the pharmacy was changed without the change being reported as 18 |
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| 470 | + | provided in § 36-11-39; 19 |
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| 471 | + | (6) The pharmacy was kept open for the transaction of business after the pharmacist 20 |
---|
| 472 | + | ceased to be in active management of the pharmacy; or 21 |
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| 473 | + | (7) The minimum requirements of this chapter and the board are no longer met . 22 |
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| 474 | + | A pharmacy license may not be suspended or revoked except by a vote of three or 23 |
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| 475 | + | more members of the board. 24 |
---|
| 476 | + | Section 30. That § 36-11-67 be AMENDED: 25 |
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| 477 | + | 36-11-67. Pharmacists licensed under this chapter A pharmacist or physicians 26 |
---|
| 478 | + | physician licensed under chapter 36-4 who participate on participates in a drug utilization 27 |
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| 479 | + | review program as defined in § 36-11-2 are is not individually or jointly not subject to, 28 |
---|
| 480 | + | and are is immune from, claim, suit, liability, damages, or any other recourse, civil or 29 |
---|
| 481 | + | criminal, arising from any act or proceeding, decision, or determination undertaken, 30 |
---|
| 482 | + | performed, or reached in good faith and without malice when acting individually or jointly 31 |
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| 483 | + | in carrying out the responsibilities, authority, duties, powers, and privileges of the 32 25.365.18 15 1016 |
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| 484 | + | Underscores indicate new language. |
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| 485 | + | Overstrikes indicate deleted language. |
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| 486 | + | program conferred upon them under any provisions of law or rule, good faith being 1 |
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| 487 | + | presumed until proven otherwise, with malice required to be shown by the complainant. 2 |
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| 488 | + | For the purposes of this section, a "drug utilization review program" is a program 3 |
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| 489 | + | operated solely or partially as a professional standards review organization whose purpose 4 |
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| 490 | + | is to: 5 |
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| 491 | + | (1) Educate pharmacists and practitioners on: 6 |
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| 492 | + | (a) Severe adverse reactions to drugs; 7 |
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| 493 | + | (b) Therapeutic appropriateness; 8 |
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| 494 | + | (c) Overutilization; 9 |
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| 495 | + | (d) Underutilization; 10 |
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| 496 | + | (e) Appropriate use of generic products; 11 |
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| 497 | + | (f) Therapeutic duplication; 12 |
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| 498 | + | (g) Drug-disease contraindications; 13 |
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| 499 | + | (h) Drug-drug interactions; 14 |
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| 500 | + | (i) Incorrect drug dosage or duration of drug treatment; 15 |
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| 501 | + | (j) Drug-allergy interactions; and 16 |
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| 502 | + | (k) Clinical abuse or misuse; and 17 |
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| 503 | + | (2) Identify and reduce the frequency of patterns of potential and actual fraud, abuse, 18 |
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| 504 | + | gross overuse, inappropriate care, or medically unnecessary care associated with 19 |
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| 505 | + | specific drugs or groups of drugs among practitioners, pharmacists, and patients. 20 |
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| 506 | + | Section 31. That § 36-11-72 be AMENDED: 21 |
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| 507 | + | 36-11-72. The board shall promulgate rules pursuant to chapter 1-26 to provide 22 |
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| 508 | + | for the regulation of telepharmacy in the this state. The rules shall include must provide 23 |
---|
| 509 | + | for: 24 |
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| 510 | + | (1) License and renewal application requirements, including establishment: 25 |
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| 511 | + | (a) Establishment of an annual initial license fee and a renewal fee, each not to 26 |
---|
| 512 | + | exceed two hundred fifty dollars; 27 |
---|
| 513 | + | (b) Procedures for the reinstatement of an expired license; and 28 |
---|
| 514 | + | (c) Establishment of a late fee for reinstating an expired license, not to exceed 29 |
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| 515 | + | fifty dollars; 30 |
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| 516 | + | (2) Minimum structural, security, and equipment requirements for the remote 31 |
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| 517 | + | pharmacy; 32 |
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| 518 | + | (3) Minimum staffing requirements for the central pharmacy and remote pharmacy; 33 |
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| 519 | + | (4) Record keeping requirements for the central pharmacy and remote pharmacy; 34 25.365.18 16 1016 |
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| 520 | + | Underscores indicate new language. |
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| 521 | + | Overstrikes indicate deleted language. |
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| 522 | + | (5) Establishment of policies Policies and procedures for the daily operation of the 1 |
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| 523 | + | remote pharmacy; and 2 |
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| 524 | + | (6) Use of automated dispensing machines. 3 |
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| 525 | + | Section 32. That a NEW SECTION be added to chapter 36-11: 4 |
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| 526 | + | If the majority of ownership of a remote pharmacy changes, the new owners must, 5 |
---|
| 527 | + | within thirty days after the ownership change: 6 |
---|
| 528 | + | (1) Submit the renewal application prescribed by the board, as provided in § 36-11-7 |
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| 529 | + | 72, indicating the change of ownership; and 8 |
---|
| 530 | + | (2) Pay the renewal fee established by the board, as provided in § 36-11-72. 9 |
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| 531 | + | Section 33. That § 36-11A-8 be AMENDED: 10 |
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| 532 | + | 36-11A-8. An applicant for licensure as a To apply for a wholesale or other drug 11 |
---|
| 533 | + | distributor shall apply annually to the board license, a person must submit an application 12 |
---|
| 534 | + | on a form provided by the board. The application shall be accompanied by a and pay an 13 |
---|
| 535 | + | annual license fee set by the board. The fee may not exceed two , not to exceed five 14 |
---|
| 536 | + | hundred fifty dollars. 15 |
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| 537 | + | All financial statements or related information submitted by applicants shall must 16 |
---|
| 538 | + | be treated as confidential materials. 17 |
---|
| 539 | + | Section 34. That § 36-11A-13 be AMENDED: 18 |
---|
| 540 | + | 36-11A-13. Each wholesale drug distributor license expires on December thirty-19 |
---|
| 541 | + | first following the date of issue issuance. The board shall provide an application for license 20 |
---|
| 542 | + | renewal to each licensee before December first of each year. To renew a license, the 21 |
---|
| 543 | + | licensee shall submit the renewal application and pay the annual license fee set by the 22 |
---|
| 544 | + | board as provided in § 36-11A-8. If application for renewal of the license accompanied by 23 |
---|
| 545 | + | the annual license fee is not made before the expiration date, the existing license lapses 24 |
---|
| 546 | + | on the date of expiration. If the board receives a renewal application and fee for an expired 25 |
---|
| 547 | + | license, the board must assess a fifty-dollar late fee and may reinstate the license. 26 |
---|
| 548 | + | If the majority of ownership of a licensed facility changes, the new owners must, 27 |
---|
| 549 | + | within thirty days after the ownership change: 28 |
---|
| 550 | + | (1) Submit a renewal application, indicating the change of ownership; and 29 |
---|
| 551 | + | (2) Pay a fee equal to the annual license fee. 30 |
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| 552 | + | Section 35. That § 36-11-3 be REPEALED. 31 25.365.18 17 1016 |
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| 553 | + | Underscores indicate new language. |
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| 554 | + | Overstrikes indicate deleted language. |
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| 555 | + | Those registered pharmacists of this state electing to participate shall constitute 1 |
---|
| 556 | + | an association under the name and title of the South Dakota Pharmacists Association. The 2 |
---|
| 557 | + | purpose of the association is to serve as the state professional society of pharmacists 3 |
---|
| 558 | + | which represents the profession of pharmacy, enhances the public's awareness of 4 |
---|
| 559 | + | pharmacy, and serves the best interest of public health and pharmacy. The South Dakota 5 |
---|
| 560 | + | Pharmacists Association shall be conducted as a nonprofit corporation pursuant to the 6 |
---|
| 561 | + | terms of its articles of incorporation. The members of the association who have secured a 7 |
---|
| 562 | + | current annual certificate of registration to practice pharmacy in this state and who have 8 |
---|
| 563 | + | elected to participate in the association are entitled to all of the rights and privileges of 9 |
---|
| 564 | + | the association and may vote, serve as an officer or director of the association, and 10 |
---|
| 565 | + | participate in all of the meetings of the association. The association shall hold an annual 11 |
---|
| 566 | + | meeting at such time and place as it determines. 12 |
---|
| 567 | + | Section 36. That § 36-11-6 be REPEALED. 13 |
---|
| 568 | + | The board may, upon receipt, pay to the South Dakota Pharmacists Association 14 |
---|
| 569 | + | eighty percent of all fees the board receives for renewals of certificates of registration as 15 |
---|
| 570 | + | a pharmacist. The association shall use the funds for the following association activities to 16 |
---|
| 571 | + | benefit the public and the profession: continuing education, matters related to registration 17 |
---|
| 572 | + | standards for pharmacists, professional service standards, and general operating 18 |
---|
| 573 | + | expenses related to the activities enumerated in this section. The association shall also 19 |
---|
| 574 | + | use funds received to pay any legislated assessment to support a diversion program for 20 |
---|
| 575 | + | chemically impaired pharmacists. Expenditures of funds shall be approved by the 21 |
---|
| 576 | + | president and treasurer of the association. The association shall annually file in the office 22 |
---|
| 577 | + | of the board an itemized statement of the receipts of the association and disbursements 23 |
---|
| 578 | + | from the receipts. 24 |
---|
| 579 | + | Section 37. That § 36-11-17 be REPEALED. 25 |
---|
| 580 | + | Every person initially applying for a certificate of registration with the Board of 26 |
---|
| 581 | + | Pharmacy as a registered pharmacist shall pay to the board with the application a fee, not 27 |
---|
| 582 | + | to exceed thirty-five dollars, set by the board by rule promulgated pursuant to chapter 1-28 |
---|
| 583 | + | 26. 29 |
---|
| 584 | + | Section 38. That § 36-11-18 be REPEALED. 30 25.365.18 18 1016 |
---|
| 585 | + | Underscores indicate new language. |
---|
| 586 | + | Overstrikes indicate deleted language. |
---|
| 587 | + | It shall be the duty of the Board of Pharmacy to examine all applications for 1 |
---|
| 588 | + | registration submitted in due form as provided in the rules and regulations of the board 2 |
---|
| 589 | + | and to grant certificates of registration to such persons as may be entitled to the same 3 |
---|
| 590 | + | under the provisions of this chapter. 4 |
---|
| 591 | + | Section 39. That § 36-11-22 be REPEALED. 5 |
---|
| 592 | + | The Board of Pharmacy shall keep a record of registration in which shall be entered 6 |
---|
| 593 | + | the names and places of business of all persons registered under this chapter which 7 |
---|
| 594 | + | records shall also specify such facts as such persons shall claim to justify their registration. 8 |
---|
| 595 | + | Section 40. That § 36-11-28 be REPEALED. 9 |
---|
| 596 | + | A certificate of registration as a pharmacist shall not be revoked or suspended 10 |
---|
| 597 | + | except after hearing before the Board of Pharmacy at which a majority of its members are 11 |
---|
| 598 | + | present and in compliance with chapter 1-26. 12 |
---|
| 599 | + | Section 41. That § 36-11-29 be REPEALED. 13 |
---|
| 600 | + | An appeal from the decision of the Board of Pharmacy may be taken as provided 14 |
---|
| 601 | + | by chapter 1-26. 15 |
---|
| 602 | + | Section 42. That § 36-11-40 be REPEALED. 16 |
---|
| 603 | + | Any permit issued under the provisions of § 36-11-32 shall be void if the active 17 |
---|
| 604 | + | management of any pharmacy is changed without the transfer, as provided in § 36-11-18 |
---|
| 605 | + | 37, of the permit therefor, or if the location of said pharmacy is changed without the same 19 |
---|
| 606 | + | being reported as provided in § 36-11-39, or if the pharmacy is kept open for business 20 |
---|
| 607 | + | after the permittee has ceased to be in active management of said pharmacy, and 21 |
---|
| 608 | + | whenever the minimum requirements of this chapter and the Board of Pharmacy are no 22 |
---|
| 609 | + | longer met. 23 |
---|
| 610 | + | Section 43. That § 36-11-42 be REPEALED. 24 |
---|
| 611 | + | Any permit issued under the provisions of § 36-11-32 shall be void and subject to 25 |
---|
| 612 | + | cancellation by the State Board of Pharmacy, unless such pharmacy is maintained and 26 |
---|
| 613 | + | operated in a clean and sanitary condition, free from unhealthful, foreign, or injurious 27 |
---|
| 614 | + | contamination. 28 25.365.18 19 1016 |
---|
| 615 | + | Underscores indicate new language. |
---|
| 616 | + | Overstrikes indicate deleted language. |
---|
| 617 | + | Section 44. That § 36-11-49 be REPEALED. 1 |
---|
| 618 | + | Before any permit for a pharmacy shall be revoked chapter 1-26 shall be complied 2 |
---|
| 619 | + | with. Two members of the board shall constitute a quorum and no permit shall be revoked 3 |
---|
| 620 | + | except by a vote of two or more members of the State Board of Pharmacy. 4 |
---|
| 621 | + | Section 45. That § 36-11A-4.2 be REPEALED. 5 |
---|
| 622 | + | No outsourcing facility engaged in compounding of nonpatient specific sterile and 6 |
---|
| 623 | + | nonsterile drugs may become licensed by the board without first obtaining a registration 7 |
---|
| 624 | + | and inspection by the United States Food and Drug Administration, and paying the license 8 |
---|
| 625 | + | fee set by the board in rules promulgated pursuant to chapter 1-26. The fee may not 9 |
---|
| 626 | + | exceed two hundred dollars. 10 |
---|
| 627 | + | Section 46. No later than September 30, 2025, the Board of Pharmacy shall, pursuant to 11 |
---|
| 628 | + | chapter 1-26, provide for and file with the secretary of state, the amendment of ARSD 12 |
---|
| 629 | + | 20:67:02:01, as set forth below: 13 |
---|
| 630 | + | 20:67:02:01. Application and fee. A wholesale or other distributor must 14 |
---|
| 631 | + | apply each year to the board, electronically or on a form supplied by the secretary of the 15 |
---|
| 632 | + | board, for a license to engage in the distribution of prescription drugs. Each application 16 |
---|
| 633 | + | shall must be accompanied by a license fee of $200 five hundred dollars. 17 |
---|
| 634 | + | Source: 18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May 18 |
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| 635 | + | 26, 1998; 45 SDR 86, effective December 24, 2018. 19 |
---|
| 636 | + | General Authority: SDCL 36-11A-14(1),(6). 20 |
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| 637 | + | Law Implemented: SDCL 36-11A-7, 36-11A-8. 21 |
---|