Georgia 2025-2026 Regular Session

Georgia Senate Bill SB314 Compare Versions

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11 25 LC 46 1151
22 Senate Bill 314
33 By: Senators Esteves of the 35th, Jones II of the 22nd, Jackson of the 41st, Parent of the 44th,
44 McLaurin of the 14th and others
55 A BILL TO BE ENTITLED
66 AN ACT
77 To amend Title 31 of the Official Code of Georgia Annotated, relating to health, so as to
88 1
99 provide for the establishment of a wholesale prescription drug importation program and the2
1010 procedures for implementing such program; to provide for definitions; to provide for related3
1111 matters; to provide for contingent effectiveness upon appropriation of funds; to provide for4
1212 a short title; to provide for a legislative finding; to repeal conflicting laws; and for other5
1313 purposes.6
1414 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:7
1515 SECTION 1.8
1616 This Act shall be known and may be cited as the "Wholesale Prescription Drug Importation9
1717 Act."10
1818 SECTION 2.11
1919 The General Assembly finds that access to affordable medications is a public health issue12
2020 that impacts many Georgians and the establishment of a wholesale prescription drug13
2121 importation program can serve as a solution to thousands of those Georgians and may14
2222 provide them with the opportunity to obtain life-saving and life-preserving medications.15
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2525 SECTION 3.
2626 16
2727 Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by adding17
2828 a new chapter to read as follows:18
2929 "CHAPTER 8A
3030 19
3131 31-8A-1.20
3232 As used in this chapter, the term:21
3333 (1) 'Canadian supplier' means a manufacturer, wholesale distributor, or pharmacy that22
3434 is appropriately licensed or permitted under Canadian federal or provincial laws and rules23
3535 to manufacture, distribute, or dispense prescription drugs.24
3636 (2) 'Commissioner' means the commissioner of community health.25
3737 (3) 'Department' means the Department of Community Health.26
3838 (4) 'Division' means the division within the Department of Community Health that27
3939 administers the wholesale prescription drug importation program.28
4040 (5) 'Health benefit plan' means a policy, contract, certificate, or agreement entered into,29
4141 offered by, or issued by an insurer to provide, deliver, arrange for, pay for, or reimburse30
4242 any of the costs of healthcare services.31
4343 (6) 'Healthcare provider' means any of the following who provide medical, dental, or32
4444 other health related diagnoses, care, or treatment:33
4545 (A) Dentists and dental hygienists licensed under Chapter 11 of Title 43;34
4646 (B) Optometrists licensed under Chapter 30 of Title 43;35
4747 (C) Pharmacists licensed under Chapter 4 of Title 26;36
4848 (D) Physician assistants licensed under Chapter 34 of Title 43;37
4949 (E) Physicians licensed to practice medicine under Chapter 34 of Title 43; and38
5050 (F) Registered nurses and licensed practical nurses licensed under Chapter 26 of39
5151 Title 43.40
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5454 (7) 'Prescription drug wholesaler' means an entity licensed by the State Board of41
5555 Pharmacy as a wholesale distributor under Chapter 4 of Title 26 that contracts with this42
5656 state to import prescription drugs into this state under the program.43
5757 (8) 'Program' means the wholesale prescription drug importation program established44
5858 under this chapter.45
5959 31-8A-2.46
6060 (a) The department, in consultation with the State Board of Pharmacy and interested47
6161 parties, shall design and establish a wholesale prescription drug importation program that48
6262 complies with the applicable requirements of 21 U.S.C. Section 384 and in conformity with49
6363 applicable federal regulations. The purpose of such drug importation program shall be to50
6464 provide better access to prescription drugs and a significant reduction in prescription drug51
6565 costs for patients in this state.52
6666 (b) The division shall implement the program by:53
6767 (1) Contracting with one or more prescription drug wholesalers and Canadian suppliers54
6868 to import prescription drugs and provide prescription drug cost savings to consumers in55
6969 this state;56
7070 (2) Developing a registration process for health benefit plans, healthcare providers, and57
7171 pharmacies to obtain and dispense prescription drugs imported under the program;58
7272 (3) Developing a list of prescription drugs, including the prices of those drugs, that meet59
7373 the requirements of Code Section 31-8A-3 and publishing the list on the department's60
7474 public website;61
7575 (4) Establishing an outreach and marketing plan to generate program awareness;62
7676 (5) Establishing and administering a telephone call center or electronic portal to provide63
7777 information about the program;64
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8080 (6) Ensuring the program and the prescription drug wholesalers that contract with this65
8181 state in accordance with this chapter comply with the tracking, tracing, verification, and66
8282 identification requirements of 21 U.S.C. Section 360eee-1;67
8383 (7) Prohibiting the distribution, dispensing, or sale of prescription drugs imported under68
8484 this chapter outside the boundaries of this state;69
8585 (8) Ensuring that the program meets the requirements of 21 U.S.C. Section 384; 70
8686 (9) Consulting with the State Board of Pharmacy and other interested parties; and71
8787 (10) Performing any other duties the commissioner determines necessary to implement72
8888 the program.73
8989 31-8A-3.74
9090 A prescription drug may be imported into this state under the program only if the drug:75
9191 (1) Meets the United States Food and Drug Administration's standards related to76
9292 prescription drug safety, effectiveness, misbranding, and adulteration;77
9393 (2) Does not violate any federal patent laws through its importation;78
9494 (3) Is expected to generate cost savings for consumers; and79
9595 (4) Is not:80
9696 (A) Listed as a controlled substance under state or federal law;81
9797 (B) A biological product, as defined in subsection (i) of Section 351 of the federal82
9898 Public Health Service Act, 42 U.S.C. Section 262, as of January 1, 2025;83
9999 (C) An infused drug;84
100100 (D) An intravenously injected drug;85
101101 (E) A drug that is inhaled during surgery; or86
102102 (F) A parenteral drug.87
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105105 31-8A-4.88
106106 The division, in consultation with this state's Attorney General, shall identify and monitor89
107107 any potential anticompetitive activities in industries affected by the program.90
108108 31-8A-5.91
109109 The commissioner shall promulgate rules and regulations to effectively audit a prescription92
110110 drug wholesaler participating in the program.93
111111 31-8A-6.94
112112 No later than December 1 of each year, the department shall submit a report to the95
113113 Governor and the General Assembly regarding the operation of the program during the96
114114 preceding fiscal year, including:97
115115 (1) Which prescription drugs and Canadian suppliers are included in the program;98
116116 (2) The number of health benefit plans, healthcare providers, and pharmacies99
117117 participating in the program;100
118118 (3) The number of prescriptions dispensed through the program;101
119119 (4) The estimated cost savings to consumers, health benefit plans, employers, and this102
120120 state since the establishment of the program and during the preceding fiscal year;103
121121 (5) Information regarding the implementation of the audit referenced in this chapter; and104
122122 (6) Any other information the Governor, General Assembly, or department considers105
123123 necessary.106
124124 31-8A-7.107
125125 The commissioner shall adopt any rules and regulations necessary to implement this108
126126 chapter.109
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129129 31-8A-8.110
130130 If, before implementing any provision of this chapter, the department, the Board of111
131131 Pharmacy, or any state agency determines that a waiver or authorization from a federal112
132132 agency is necessary for implementation of any portion of this chapter, the agency affected113
133133 shall request the waiver or authorization and may delay implementing the provisions of this114
134134 chapter until the waiver or authorization is granted."115
135135 SECTION 4.116
136136 This Act shall become effective on July 1, 2026, only if funds are specifically appropriated117
137137 for the purposes of this Act in an appropriations Act before such date which makes specific118
138138 reference to this Act and such funds so appropriated have become available for expenditure. 119
139139 SECTION 5. 120
140140 All laws and parts of laws in conflict with this Act are repealed.121
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