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, relating to health, so as to
provide for the establishment of a wholesale prescription drug importation program and the
procedures for implementing such program; to provide for definitions; to provide for related
matters; to provide for contingent effectiveness upon appropriation of funds; to provide for
a short title; to provide for a legislative finding; to repeal conflicting laws; and for other
purposes.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION 1.
This Act shall be known and may be cited as the "Wholesale Prescription Drug Importation
Act."
SECTION 2.
The General Assembly finds that access to affordable medications is a public health issue
that impacts many Georgians and the establishment of a wholesale prescription drug
importation program can serve as a solution to thousands of those Georgians and may
provide them with the opportunity to obtain life-saving and life-preserving medications.
SECTION 3.
Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by adding
a new chapter to read as follows:
<ins>"CHAPTER 8A
31-8A-1.
As used in this chapter, the term:
(1) 'Canadian supplier' means a manufacturer, wholesale distributor, or pharmacy that
is appropriately licensed or permitted under Canadian federal or provincial laws and rules
to manufacture, distribute, or dispense prescription drugs.
(2) 'Commissioner' means the commissioner of community health.
(3) 'Department' means the Department of Community Health.
(4) 'Division' means the division within the Department of Community Health that
administers the wholesale prescription drug importation program.
(5) 'Health benefit plan' means a policy, contract, certificate, or agreement entered into,
offered by, or issued by an insurer to provide, deliver, arrange for, pay for, or reimburse
any of the costs of healthcare services.
(6) 'Healthcare provider' means any of the following who provide medical, dental, or
other health related diagnoses, care, or treatment:
(A) Dentists and dental hygienists licensed under Chapter 11 of Title 43;
(B) Optometrists licensed under Chapter 30 of Title 43;
(C) Pharmacists licensed under Chapter 4 of Title 26;
(D) Physician assistants licensed under Chapter 34 of Title 43;
(E) Physicians licensed to practice medicine under Chapter 34 of Title 43; and
(F) Registered nurses and licensed practical nurses licensed under Chapter 26 of
Title 43.
</ins>
<ins>(7) 'Prescription drug wholesaler' means an entity licensed by the State Board of
Pharmacy as a wholesale distributor under Chapter 4 of Title 26 that contracts with this
state to import prescription drugs into this state under the program.
(8) 'Program' means the wholesale prescription drug importation program established
under this chapter.
31-8A-2.
(a) The department, in consultation with the State Board of Pharmacy and interested
parties, shall design and establish a wholesale prescription drug importation program that
complies with the applicable requirements of 21 U.S.C. Section 384 and in conformity with
applicable federal regulations. The purpose of such drug importation program shall be to
provide better access to prescription drugs and a significant reduction in prescription drug
costs for patients in this state.
(b) The division shall implement the program by:
(1) Contracting with one or more prescription drug wholesalers and Canadian suppliers
to import prescription drugs and provide prescription drug cost savings to consumers in
this state;
(2) Developing a registration process for health benefit plans, healthcare providers, and
pharmacies to obtain and dispense prescription drugs imported under the program;
(3) Developing a list of prescription drugs, including the prices of those drugs, that meet
the requirements of Code Section 31-8A-3 and publishing the list on the department's
public website;
(4) Establishing an outreach and marketing plan to generate program awareness;
(5) Establishing and administering a telephone call center or electronic portal to provide
information about the program;
</ins>
<ins>(6) Ensuring the program and the prescription drug wholesalers that contract with this
state in accordance with this chapter comply with the tracking, tracing, verification, and
identification requirements of 21 U.S.C. Section 360eee-1;
(7) Prohibiting the distribution, dispensing, or sale of prescription drugs imported under
this chapter outside the boundaries of this state;
(8) Ensuring that the program meets the requirements of 21 U.S.C. Section 384;
(9) Consulting with the State Board of Pharmacy and other interested parties; and
(10) Performing any other duties the commissioner determines necessary to implement
the program.
31-8A-3.
A prescription drug may be imported into this state under the program only if the drug:
(1) Meets the United States Food and Drug Administration's standards related to
prescription drug safety, effectiveness, misbranding, and adulteration;
(2) Does not violate any federal patent laws through its importation;
(3) Is expected to generate cost savings for consumers; and
(4) Is not:
(A) Listed as a controlled substance under state or federal law;
(B) A biological product, as defined in subsection (i) of Section 351 of the federal
Public Health Service Act, 42 U.S.C. Section 262, as of January 1, 2025;
(C) An infused drug;
(D) An intravenously injected drug;
(E) A drug that is inhaled during surgery; or
(F) A parenteral drug.
</ins>
<ins>31-8A-4.
The division, in consultation with this state's Attorney General, shall identify and monitor
any potential anticompetitive activities in industries affected by the program.
31-8A-5.
The commissioner shall promulgate rules and regulations to effectively audit a prescription
drug wholesaler participating in the program.
31-8A-6.
No later than December 1 of each year, the department shall submit a report to the
Governor and the General Assembly regarding the operation of the program during the
preceding fiscal year, including:
(1) Which prescription drugs and Canadian suppliers are included in the program;
(2) The number of health benefit plans, healthcare providers, and pharmacies
participating in the program;
(3) The number of prescriptions dispensed through the program;
(4) The estimated cost savings to consumers, health benefit plans, employers, and this
state since the establishment of the program and during the preceding fiscal year;
(5) Information regarding the implementation of the audit referenced in this chapter; and
(6) Any other information the Governor, General Assembly, or department considers
necessary.
31-8A-7.
The commissioner shall adopt any rules and regulations necessary to implement this
chapter.
</ins>
<ins>31-8A-8.
If, before implementing any provision of this chapter, the department, the Board of
Pharmacy, or any state agency determines that a waiver or authorization from a federal
agency is necessary for implementation of any portion of this chapter, the agency affected
shall request the waiver or authorization and may delay implementing the provisions of this
chapter until the waiver or authorization is granted."
</ins> SECTION 4.
This Act shall become effective on July 1, 2026, only if funds are specifically appropriated
for the purposes of this Act in an appropriations Act before such date which makes specific
reference to this Act and such funds so appropriated have become available for expenditure.
SECTION 5.
All laws and parts of laws in conflict with this Act are repealed.