1 | 1 | | 25 LC 46 1151 |
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2 | 2 | | Senate Bill 314 |
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3 | 3 | | By: Senators Esteves of the 35th, Jones II of the 22nd, Jackson of the 41st, Parent of the 44th, |
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4 | 4 | | McLaurin of the 14th and others |
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5 | 5 | | A BILL TO BE ENTITLED |
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6 | 6 | | AN ACT |
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7 | 7 | | To amend Title 31 of the Official Code of Georgia Annotated, relating to health, so as to |
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8 | 8 | | 1 |
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9 | 9 | | provide for the establishment of a wholesale prescription drug importation program and the2 |
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10 | 10 | | procedures for implementing such program; to provide for definitions; to provide for related3 |
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11 | 11 | | matters; to provide for contingent effectiveness upon appropriation of funds; to provide for4 |
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12 | 12 | | a short title; to provide for a legislative finding; to repeal conflicting laws; and for other5 |
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13 | 13 | | purposes.6 |
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14 | 14 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:7 |
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15 | 15 | | SECTION 1.8 |
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16 | 16 | | This Act shall be known and may be cited as the "Wholesale Prescription Drug Importation9 |
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17 | 17 | | Act."10 |
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18 | 18 | | SECTION 2.11 |
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19 | 19 | | The General Assembly finds that access to affordable medications is a public health issue12 |
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20 | 20 | | that impacts many Georgians and the establishment of a wholesale prescription drug13 |
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21 | 21 | | importation program can serve as a solution to thousands of those Georgians and may14 |
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22 | 22 | | provide them with the opportunity to obtain life-saving and life-preserving medications.15 |
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23 | 23 | | S. B. 314 |
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24 | 24 | | - 1 - 25 LC 46 1151 |
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25 | 25 | | SECTION 3. |
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26 | 26 | | 16 |
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27 | 27 | | Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by adding17 |
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28 | 28 | | a new chapter to read as follows:18 |
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29 | 29 | | "CHAPTER 8A |
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30 | 30 | | 19 |
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31 | 31 | | 31-8A-1.20 |
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32 | 32 | | As used in this chapter, the term:21 |
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33 | 33 | | (1) 'Canadian supplier' means a manufacturer, wholesale distributor, or pharmacy that22 |
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34 | 34 | | is appropriately licensed or permitted under Canadian federal or provincial laws and rules23 |
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35 | 35 | | to manufacture, distribute, or dispense prescription drugs.24 |
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36 | 36 | | (2) 'Commissioner' means the commissioner of community health.25 |
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37 | 37 | | (3) 'Department' means the Department of Community Health.26 |
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38 | 38 | | (4) 'Division' means the division within the Department of Community Health that27 |
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39 | 39 | | administers the wholesale prescription drug importation program.28 |
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40 | 40 | | (5) 'Health benefit plan' means a policy, contract, certificate, or agreement entered into,29 |
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41 | 41 | | offered by, or issued by an insurer to provide, deliver, arrange for, pay for, or reimburse30 |
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42 | 42 | | any of the costs of healthcare services.31 |
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43 | 43 | | (6) 'Healthcare provider' means any of the following who provide medical, dental, or32 |
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44 | 44 | | other health related diagnoses, care, or treatment:33 |
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45 | 45 | | (A) Dentists and dental hygienists licensed under Chapter 11 of Title 43;34 |
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46 | 46 | | (B) Optometrists licensed under Chapter 30 of Title 43;35 |
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47 | 47 | | (C) Pharmacists licensed under Chapter 4 of Title 26;36 |
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48 | 48 | | (D) Physician assistants licensed under Chapter 34 of Title 43;37 |
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49 | 49 | | (E) Physicians licensed to practice medicine under Chapter 34 of Title 43; and38 |
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50 | 50 | | (F) Registered nurses and licensed practical nurses licensed under Chapter 26 of39 |
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51 | 51 | | Title 43.40 |
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52 | 52 | | S. B. 314 |
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53 | 53 | | - 2 - 25 LC 46 1151 |
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54 | 54 | | (7) 'Prescription drug wholesaler' means an entity licensed by the State Board of41 |
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55 | 55 | | Pharmacy as a wholesale distributor under Chapter 4 of Title 26 that contracts with this42 |
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56 | 56 | | state to import prescription drugs into this state under the program.43 |
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57 | 57 | | (8) 'Program' means the wholesale prescription drug importation program established44 |
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58 | 58 | | under this chapter.45 |
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59 | 59 | | 31-8A-2.46 |
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60 | 60 | | (a) The department, in consultation with the State Board of Pharmacy and interested47 |
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61 | 61 | | parties, shall design and establish a wholesale prescription drug importation program that48 |
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62 | 62 | | complies with the applicable requirements of 21 U.S.C. Section 384 and in conformity with49 |
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63 | 63 | | applicable federal regulations. The purpose of such drug importation program shall be to50 |
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64 | 64 | | provide better access to prescription drugs and a significant reduction in prescription drug51 |
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65 | 65 | | costs for patients in this state.52 |
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66 | 66 | | (b) The division shall implement the program by:53 |
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67 | 67 | | (1) Contracting with one or more prescription drug wholesalers and Canadian suppliers54 |
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68 | 68 | | to import prescription drugs and provide prescription drug cost savings to consumers in55 |
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69 | 69 | | this state;56 |
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70 | 70 | | (2) Developing a registration process for health benefit plans, healthcare providers, and57 |
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71 | 71 | | pharmacies to obtain and dispense prescription drugs imported under the program;58 |
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72 | 72 | | (3) Developing a list of prescription drugs, including the prices of those drugs, that meet59 |
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73 | 73 | | the requirements of Code Section 31-8A-3 and publishing the list on the department's60 |
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74 | 74 | | public website;61 |
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75 | 75 | | (4) Establishing an outreach and marketing plan to generate program awareness;62 |
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76 | 76 | | (5) Establishing and administering a telephone call center or electronic portal to provide63 |
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77 | 77 | | information about the program;64 |
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78 | 78 | | S. B. 314 |
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79 | 79 | | - 3 - 25 LC 46 1151 |
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80 | 80 | | (6) Ensuring the program and the prescription drug wholesalers that contract with this65 |
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81 | 81 | | state in accordance with this chapter comply with the tracking, tracing, verification, and66 |
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82 | 82 | | identification requirements of 21 U.S.C. Section 360eee-1;67 |
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83 | 83 | | (7) Prohibiting the distribution, dispensing, or sale of prescription drugs imported under68 |
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84 | 84 | | this chapter outside the boundaries of this state;69 |
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85 | 85 | | (8) Ensuring that the program meets the requirements of 21 U.S.C. Section 384; 70 |
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86 | 86 | | (9) Consulting with the State Board of Pharmacy and other interested parties; and71 |
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87 | 87 | | (10) Performing any other duties the commissioner determines necessary to implement72 |
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88 | 88 | | the program.73 |
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89 | 89 | | 31-8A-3.74 |
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90 | 90 | | A prescription drug may be imported into this state under the program only if the drug:75 |
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91 | 91 | | (1) Meets the United States Food and Drug Administration's standards related to76 |
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92 | 92 | | prescription drug safety, effectiveness, misbranding, and adulteration;77 |
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93 | 93 | | (2) Does not violate any federal patent laws through its importation;78 |
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94 | 94 | | (3) Is expected to generate cost savings for consumers; and79 |
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95 | 95 | | (4) Is not:80 |
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96 | 96 | | (A) Listed as a controlled substance under state or federal law;81 |
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97 | 97 | | (B) A biological product, as defined in subsection (i) of Section 351 of the federal82 |
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98 | 98 | | Public Health Service Act, 42 U.S.C. Section 262, as of January 1, 2025;83 |
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99 | 99 | | (C) An infused drug;84 |
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100 | 100 | | (D) An intravenously injected drug;85 |
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101 | 101 | | (E) A drug that is inhaled during surgery; or86 |
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102 | 102 | | (F) A parenteral drug.87 |
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103 | 103 | | S. B. 314 |
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104 | 104 | | - 4 - 25 LC 46 1151 |
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105 | 105 | | 31-8A-4.88 |
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106 | 106 | | The division, in consultation with this state's Attorney General, shall identify and monitor89 |
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107 | 107 | | any potential anticompetitive activities in industries affected by the program.90 |
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108 | 108 | | 31-8A-5.91 |
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109 | 109 | | The commissioner shall promulgate rules and regulations to effectively audit a prescription92 |
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110 | 110 | | drug wholesaler participating in the program.93 |
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111 | 111 | | 31-8A-6.94 |
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112 | 112 | | No later than December 1 of each year, the department shall submit a report to the95 |
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113 | 113 | | Governor and the General Assembly regarding the operation of the program during the96 |
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114 | 114 | | preceding fiscal year, including:97 |
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115 | 115 | | (1) Which prescription drugs and Canadian suppliers are included in the program;98 |
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116 | 116 | | (2) The number of health benefit plans, healthcare providers, and pharmacies99 |
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117 | 117 | | participating in the program;100 |
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118 | 118 | | (3) The number of prescriptions dispensed through the program;101 |
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119 | 119 | | (4) The estimated cost savings to consumers, health benefit plans, employers, and this102 |
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120 | 120 | | state since the establishment of the program and during the preceding fiscal year;103 |
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121 | 121 | | (5) Information regarding the implementation of the audit referenced in this chapter; and104 |
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122 | 122 | | (6) Any other information the Governor, General Assembly, or department considers105 |
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123 | 123 | | necessary.106 |
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124 | 124 | | 31-8A-7.107 |
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125 | 125 | | The commissioner shall adopt any rules and regulations necessary to implement this108 |
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126 | 126 | | chapter.109 |
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127 | 127 | | S. B. 314 |
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128 | 128 | | - 5 - 25 LC 46 1151 |
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129 | 129 | | 31-8A-8.110 |
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130 | 130 | | If, before implementing any provision of this chapter, the department, the Board of111 |
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131 | 131 | | Pharmacy, or any state agency determines that a waiver or authorization from a federal112 |
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132 | 132 | | agency is necessary for implementation of any portion of this chapter, the agency affected113 |
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133 | 133 | | shall request the waiver or authorization and may delay implementing the provisions of this114 |
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134 | 134 | | chapter until the waiver or authorization is granted."115 |
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135 | 135 | | SECTION 4.116 |
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136 | 136 | | This Act shall become effective on July 1, 2026, only if funds are specifically appropriated117 |
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137 | 137 | | for the purposes of this Act in an appropriations Act before such date which makes specific118 |
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138 | 138 | | reference to this Act and such funds so appropriated have become available for expenditure. 119 |
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139 | 139 | | SECTION 5. 120 |
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140 | 140 | | All laws and parts of laws in conflict with this Act are repealed.121 |
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141 | 141 | | S. B. 314 |
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142 | 142 | | - 6 - |
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