SB314: SB314 "Wholesale Prescription Drug Importation Act"; enact

25 LC 46 1151 Senate Bill 314 By: Senators Esteves of the 35th, Jones II of the 22nd, Jackson of the 41st, Parent of the 44th, McLaurin of the 14th and others A BILL TO BE ENTITLED AN ACT To amend Title 31 of the Official Code of Georgia Annotated, re lating to health, so as to1 provide for the establishment of a wholesale prescription drug importation program and the2 procedures for implementing such program; to provide for definitions; to provide for related3 matters; to provide for contingent effectiveness upon appropriation of funds; to provide for4 a short title; to provide for a legislative finding; to repeal conflicting laws; and for other5 purposes.6 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:7 SECTION 1.8 This Act shall be known and may be cited as the "Wholesale Prescription Drug Importation9 Act."10 SECTION 2.11 The General Assembly finds that access to affordable medication s is a public health issue12 that impacts many Georgians and the establishment of a wholesal e prescription drug13 importation program can serve as a solution to thousands of tho se Georgians and may14 provide them with the opportunity to obtain life-saving and life-preserving medications.15 S. B. 314 - 1 - 25 LC 46 1151 SECTION 3.16 Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by adding17 a new chapter to read as follows:18 "CHAPTER 8A19 31-8A-1.20 As used in this chapter, the term:21 (1) 'Canadian supplier' means a manufacturer, wholesale distri butor, or pharmacy that22 is appropriately licensed or permitted under Canadian federal or provincial laws and rules23 to manufacture, distribute, or dispense prescription drugs.24 (2) 'Commissioner' means the commissioner of community health.25 (3) 'Department' means the Department of Community Health.26 (4) 'Division' means the division within the Department of Com munity Health that27 administers the wholesale prescription drug importation program.28 (5) 'Health benefit plan' means a policy, contract, certificate, or agreement entered into,29 offered by, or issued by an insurer to provide, deliver, arrange for, pay for, or reimburse30 any of the costs of healthcare services.31 (6) 'Healthcare provider' means any of the following who provi de medical, dental, or32 other health related diagnoses, care, or treatment:33 (A) Dentists and dental hygienists licensed under Chapter 11 of Title 43;34 (B) Optometrists licensed under Chapter 30 of Title 43;35 (C) Pharmacists licensed under Chapter 4 of Title 26;36 (D) Physician assistants licensed under Chapter 34 of Title 43;37 (E) Physicians licensed to practice medicine under Chapter 34 of Title 43; and38 (F) Registered nurses and licensed practical nurses licensed u nder Chapter 26 of39 Title 43.40 S. B. 314 - 2 - 25 LC 46 1151 (7) 'Prescription drug wholesaler' means an entity licensed by t h e S t a t e B o a r d o f41 Pharmacy as a wholesale distributor under Chapter 4 of Title 26 that contracts with this42 state to import prescription drugs into this state under the program.43 (8) 'Program' means the wholesale prescription drug importatio n program established44 under this chapter.45 31-8A-2.46 (a) The department, in consultation with the State Board of Ph armacy and interested47 parties, shall design and establish a wholesale prescription drug importation program that48 complies with the applicable requirements of 21 U.S.C. Section 384 and in conformity with49 applicable federal regulations. The purpose of such drug importation program shall be to50 provide better access to prescription drugs and a significant reduction in prescription drug51 costs for patients in this state.52 (b) The division shall implement the program by:53 (1) Contracting with one or more prescription drug wholesalers and Canadian suppliers54 to import prescription drugs and provide prescription drug cost savings to consumers in55 this state;56 (2) Developing a registration process for health benefit plans, healthcare providers, and57 pharmacies to obtain and dispense prescription drugs imported under the program;58 (3) Developing a list of prescription drugs, including the prices of those drugs, that meet59 the requirements of Code Section 31-8A-3 and publishing the lis t on the department's60 public website;61 (4) Establishing an outreach and marketing plan to generate program awareness;62 (5) Establishing and administering a telephone call center or electronic portal to provide63 information about the program;64 S. B. 314 - 3 - 25 LC 46 1151 (6) Ensuring the program and the prescription drug wholesalers that contract with this65 state in accordance with this chapter comply with the tracking, tracing, verification, and66 identification requirements of 21 U.S.C. Section 360eee-1;67 (7) Prohibiting the distribution, dispensing, or sale of prescription drugs imported under68 this chapter outside the boundaries of this state;69 (8) Ensuring that the program meets the requirements of 21 U.S.C. Section 384; 70 (9) Consulting with the State Board of Pharmacy and other interested parties; and71 (10) Performing any other duties the commissioner determines necessary to implement72 the program.73 31-8A-3.74 A prescription drug may be imported into this state under the program only if the drug:75 (1) Meets the United States Food and Drug Administration's sta ndards related to76 prescription drug safety, effectiveness, misbranding, and adulteration;77 (2) Does not violate any federal patent laws through its importation;78 (3) Is expected to generate cost savings for consumers; and79 (4) Is not:80 (A) Listed as a controlled substance under state or federal law;81 (B) A biological product, as defined in subsection (i) of Sect ion 351 of the federal82 Public Health Service Act, 42 U.S.C. Section 262, as of January 1, 2025;83 (C) An infused drug;84 (D) An intravenously injected drug;85 (E) A drug that is inhaled during surgery; or86 (F) A parenteral drug.87 S. B. 314 - 4 - 25 LC 46 1151 31-8A-4.88 The division, in consultation with this state's Attorney General, shall identify and monitor89 any potential anticompetitive activities in industries affected by the program.90 31-8A-5.91 The commissioner shall promulgate rules and regulations to effectively audit a prescription92 drug wholesaler participating in the program.93 31-8A-6.94 No later than December 1 of each year, the department shall sub mit a report to the95 Governor and the General Assembly regarding the operation of th e program during the96 preceding fiscal year, including:97 (1) Which prescription drugs and Canadian suppliers are included in the program;98 (2) The number of health benefit plans, healthcare providers, and pharmacies99 participating in the program;100 (3) The number of prescriptions dispensed through the program;101 (4) The estimated cost savings to consumers, health benefit plans, employers, and this102 state since the establishment of the program and during the preceding fiscal year;103 (5) Information regarding the implementation of the audit referenced in this chapter; and104 (6) Any other information the Governor, General Assembly, or de partment considers105 necessary.106 31-8A-7.107 The commissioner shall adopt any rules and regulations necessar y to implement this108 chapter.109 S. B. 314 - 5 - 25 LC 46 1151 31-8A-8.110 If, before implementing any provision of this chapter, the depa rtment, the Board of111 Pharmacy, or any state agency determines that a waiver or autho rization from a federal112 agency is necessary for implementation of any portion of this chapter, the agency affected113 shall request the waiver or authorization and may delay implementing the provisions of this114 chapter until the waiver or authorization is granted."115 SECTION 4.116 This Act shall become effective on July 1, 2026, only if funds are specifically appropriated117 for the purposes of this Act in an appropriations Act before such date which makes specific118 reference to this Act and such funds so appropriated have become available for expenditure. 119 SECTION 5. 120 All laws and parts of laws in conflict with this Act are repealed.121 S. B. 314 - 6 -