Bill Text: IL HB3310 | 2023-2024 | 103rd General Assembly | Introduced

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Bill Title: Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.

Spectrum: Partisan Bill (Republican 2-0)

Status: (Introduced) 2024-02-01 - Added Co-Sponsor Rep. Kevin Schmidt [HB3310 Detail]

Download: Illinois-2023-HB3310-Introduced.html

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103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED:
New Act
Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.
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A BILL FOR
HB3310 LRB103 30128 CPF 56552 b
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the
Canadian Prescription Drug Importation Act.
Section 3. Findings. The General Assembly finds:
(1) United States citizens pay some of the highest
prices for prescription drugs in the world, and the
Canadian government estimates that United States consumers
pay twice as much as Canadians for patented prescription
drugs and 20% more for generics.
(2) Under the United States Food and Drug
Administration's discretion not to enforce the law,
individual patients may import from Canada a 90-day supply
of prescription drugs that are less expensive than drugs
licensed by the Food and Drug Administration in the United
States.
(3) Individual importation via the Internet increases
consumer health and safety risks because many Internet
pharmacies are not licensed in Canada, and it is difficult
to verify the validity, reputation, actual identity, and
pharmacy practices of online pharmacies outside of the
United States.

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(4) The United States allows patients to travel to
other countries for surgeries and other high-risk medical
treatments without regulating that activity, and insurers
sometimes facilitate and pay for treatments outside of the
United States.
(5) The United States Food and Drug Administration
estimates that currently 40% of finished prescription drug
products are produced outside of the United States, and
80% of raw products for United States pharmaceutical
manufacturing come from outside the United States.
(6) The United States Food and Drug Administration
recently signed reciprocity agreements with European Union
regulators to accept the results of European Union
inspections of pharmaceutical manufacturing plants. Since
1973, the United States Food and Drug Administration has
had in place a Memorandum of Understanding for regulatory
cooperation around pharmaceuticals with the Canadian
regulatory authorities.
(7) Canada has a rigorous regulatory system to license
prescription drugs that is considered to be on par with
the United States licensing system.
(8) The enactment of Title II of the federal Drug
Quality and Security Act (P.L. 113-54) has resulted in
improvements in drug security and safety by implementing a
pharmaceutical track-and-trace system that could be
leveraged for the safe importation of pharmaceuticals.

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(9) The Secretary of the United States Department of
Health and Human Services may certify a prescription drug
reimportation program that is safe and saves consumers
money.
(10) The State can ensure that wholesale importation
of prescription drugs from Canada into the State will be
safe and cost-effective for State consumers.
Section 5. Program established. The Department of Public
Health shall establish the Canadian Prescription Drug
Importation Program for the importation from Canada of safe
and effective prescription drugs that have the highest
potential for cost savings to the State.
Section 10. Definitions. As used in this Act:
"Canadian supplier" means a manufacturer, wholesale
distributor, or pharmacy appropriately licensed or permitted
under Canadian law to manufacture, distribute, or dispense
prescription drugs.
"County health department" means a health care facility
established under Division 5-25 of the Counties Code.
"Department" means the Department of Public Health.
"Drug" or "prescription drug" has the same meaning as
"drugs" in Section 1 of the Pharmacy Practice Act.
"Federal act" means the Federal Food, Drug, and Cosmetic
Act as amended by the federal Drug Quality and Security Act.

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"Free clinic" means a free medical clinic as defined in
subsection (b) of Section 30 of the Good Samaritan Act.
"Medicaid pharmacy" means a pharmacy licensed under the
Pharmacy Practice Act that has a Medicaid provider agreement
in effect with the State and is in good standing with the
State.
"Pharmacist" means a person who holds an active and
unencumbered license to practice pharmacy under the Pharmacy
Practice Act.
"Program" means the Canadian Prescription Drug Importation
Program created under this Act.
"Track-and-trace" means the product-tracing process for
the components of the pharmaceutical distribution supply chain
as described in Title II of the federal Drug Quality and
Security Act.
"Vendor" means the entity contracted by the Department to
manage specified functions of the program.
Section 15. Importation process.
(a) The Department shall contract with a vendor to provide
services under the program.
(b) On or before December 1, 2023, and on or before
December 1 of each year thereafter, the vendor shall develop a
wholesale prescription drug importation list identifying the
prescription drugs that have the highest potential for cost
savings to the State. In developing the list, the vendor shall

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consider, at a minimum, which prescription drugs will provide
the greatest cost savings to State programs, including
prescription drugs for which there are shortages, specialty
prescription drugs, and high-volume prescription drugs. The
Department, in consultation with the federal department, shall
review the wholesale prescription drug importation list every
3 months to ensure that it continues to meet the requirements
of the programs and may direct the vendor to revise the list as
necessary.
(c) The vendor shall identify Canadian suppliers that are
in full compliance with relevant Canadian federal and
provincial laws and regulations and the federal act and who
have agreed to export drugs identified on the list at prices
that will provide cost savings to the State. The vendor must
verify that such Canadian suppliers meet all of the
requirements of the program while meeting or exceeding the
federal and State track-and-trace laws and regulations.
(d) The vendor shall contract with such eligible Canadian
suppliers, or facilitate contracts between eligible importers
and Canadian suppliers, to import drugs under the program.
(e) The vendor shall maintain a list of all registered
importers that participate in the program.
(f) The vendor shall ensure compliance with Title II of
the federal Drug Quality and Security Act by all suppliers,
importers and other distributors, and participants in the
program.

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(g) The vendor shall assist the Department in the
preparation of the annual report required by Section 60 of
this Act including the timely provision of any information
requested by the Department.
(h) The vendor shall provide an annual financial audit of
its operations to the Department as required by the
Department. The vendor shall also provide quarterly financial
reports specific to the program and shall include information
on the performance of its subcontractors and vendors. The
Department shall determine the format and contents of the
reports.
Section 20. Bond requirement. The Department shall require
a bond from the vendor to mitigate the financial consequences
of potential acts of malfeasance or misfeasance or fraudulent
or dishonest acts committed by the vendor, any employees of
the vendor, or its subcontractors.
Section 25. Eligible prescription drugs. Eligible
importers, as described in Section 35 of this Act, may import a
drug from an eligible Canadian supplier, as described in
Section 30 of this Act, if:
(1) the drug meets the United States Food and Drug
Administration's standards related to safety,
effectiveness, misbranding, and adulteration;
(2) importing the drug would not violate federal

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patent laws;
(3) importing the drug is expected to generate cost
savings; and
(4) the drug is not:
(i) a controlled substance as defined in 21 U.S.C.
802;
(ii) a biological product as defined in 42 U.S.C.
262;
(iii) an infused drug;
(iv) an intravenously injected drug;
(v) a drug that is inhaled during surgery; or
(vi) a drug that is a parenteral drug, the
importation of which is determined by the United
States Secretary of Health and Human Services to pose
a threat to the public health.
Section 30. Eligible Canadian suppliers. A Canadian
supplier may export prescription drugs into this State under
the program if the supplier:
(1) is in full compliance with relevant Canadian
federal and provincial laws and regulations;
(2) is identified by the vendor as eligible to
participate in the program; and
(3) submits an attestation that the supplier has a
registered agent in the United States, including the name
and United States address of the registered agent.

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Section 35. Eligible importers. The following entities may
import prescription drugs from an eligible Canadian supplier
under the program:
(1) a pharmacist or wholesaler employed by or under
contract with the Department's central pharmacy, for
distribution to a county health department or free clinic
for dispensing to clients treated in such department or
clinic;
(2) a pharmacist or wholesaler employed by or under
contract with a Medicaid pharmacy, for dispensing to the
pharmacy's Medicaid recipients;
(3) a pharmacist or wholesaler employed by or under
contract with the Department of Corrections, for
dispensing to inmates in the custody of the Department of
Corrections;
(4) a pharmacist or wholesaler employed by or under
contract with the Department of Juvenile Justice, for
dispensing to inmates in the custody of the Department of
Juvenile Justice;
(5) a pharmacist or wholesaler employed by or under
contract with a developmental disabilities center, as
defined in the Mental Health and Developmental
Disabilities Administrative Act, for dispensing to clients
treated in such center; and
(6) a pharmacist or wholesaler employed by or under

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contract with a residential treatment facility, or
"facility" as defined in the Specialized Mental Health
Rehabilitation Act of 2013 for dispensing to patients
treated in such facility.
Section 40. Distribution requirements. Eligible Canadian
suppliers and eligible importers participating under the
program:
(1) must comply with the tracking and tracing
requirements of 21 U.S.C. 360; and
(2) may not distribute, dispense, or sell prescription
drugs imported under the program outside of the State.
Section 45. Federal approval. On or before July 1, 2023,
the Department shall submit a request to the United States
Secretary of Health and Human Services for approval of the
program under paragraph (1) of 21 U.S.C. 384. The Department
shall begin operating the program within 6 months after
receiving such approval. The request must, at a minimum:
(1) describe the Department's plan for operating the
program;
(2) demonstrate how the prescription drugs imported
into this State under the program will meet the applicable
federal and State standards for safety and effectiveness;
(3) demonstrate how the drugs imported into this State
under the program will comply with federal tracing

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procedures;
(4) include a list of proposed prescription drugs that
have the highest potential for cost savings to the State
through importation at the time that the request is
submitted;
(5) estimate the total cost savings attributable to
the program;
(6) provide the costs of program implementation to the
State; and
(7) include a list of potential Canadian suppliers
from which the State would import drugs and demonstrate
that the suppliers are in full compliance with relevant
Canadian federal and provincial laws and regulations as
well as all applicable federal and State laws and
regulations.
Section 50. Prescription drug supply chain documentation.
(a) The vendor shall ensure the safety and quality of
drugs imported under the program. The vendor shall:
(1) for an initial imported shipment of a specific
drug by an importer, ensure that each batch of the drug in
the shipment is statistically sampled and tested for
authenticity and degradation in a manner consistent with
the federal act;
(2) for every subsequent imported shipment of that
drug by that importer, ensure that a statistically valid

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sample of the shipment is tested for authenticity and
degradation in a manner consistent with the federal act;
(3) certify that the drug:
(i) is approved for marketing in the United States
and is not adulterated or misbranded; and
(ii) meets all of the labeling requirements under
21 U.S.C. 352;
(4) maintain qualified laboratory records, including
complete data derived from all tests necessary to ensure
that the drug is in compliance with the requirements of
this Section.
(5) maintain documentation demonstrating that the
testing required by this Section was conducted at a
qualified laboratory in accordance with the federal act
and any other applicable federal and State laws and
regulations governing laboratory qualifications.
(b) All testing required by this Section must be conducted
in a qualified laboratory that meets the standards under the
federal act and any other applicable federal and State laws
and regulations governing laboratory qualifications for drug
testing.
(c) The vendor shall maintain information and
documentation submitted under this Section for a period of at
least 7 years.
(d) A participating importer must submit all of the
following information to the vendor:

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(1) the name and quantity of the active ingredient of
the drug;
(2) a description of the dosage form of the drug;
(3) the date on which the drug is received;
(4) the quantity of the drug that is received;
(5) the point of origin and destination of the drug;
and
(6) the price paid by the importer for the drug;
(e) A participating Canadian supplier must submit the
following information and documentation to the vendor
specifying all of the following:
(1) the original source of the drug, including:
(i) the name of the manufacturer of the drug;
(ii) the date on which the drug was manufactured;
and
(iii) the location including the country, state or
province, and city, where the drug was manufactured;
(2) the date on which the drug is shipped;
(3) the quantity of the drug that is shipped;
(4) the quantity of each lot of the drug originally
received and the source of the lot; and
(5) the lot or control number and the batch number
assigned to the drug by the manufacturer.
(f) The Department may require that the vendor collect any
other information necessary to ensure the protection of the
public health.

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Section 55. Immediate suspension. The Department shall
immediately suspend the importation of a specific drug or the
importation of drugs by a specific importer if it discovers
that any drug or activity is in violation of this Section or
any federal or State law or regulation. The Department may
revoke the suspension if, after conducting an investigation,
it determines that the public is adequately protected from
counterfeit or unsafe drugs being imported into this State.
Section 60. Annual report. On or before December 1 of each
year, the Department shall submit a report to the Governor,
the President of the Senate, and the Speaker of the House of
Representatives on the operation of the program during the
previous fiscal year. The report must include, at a minimum:
(1) a list of the prescription drugs that were
imported under the program;
(2) the number of participating entities;
(3) the number of prescriptions dispensed through the
program;
(4) the estimated cost savings during the previous
fiscal year and to date attributable to the program;
(5) a description of the methodology used to determine
which drugs should be included on the wholesale
prescription drug importation list; and
(6) documentation as to how the program ensures the

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following that:
(i) Canadian suppliers participating in the
program are of high quality, high performance, and in
full compliance with relevant Canadian federal and
provincial laws and regulations as well as all federal
laws and regulations and State laws and rules;
(ii) prescription drugs imported under the program
are not shipped, sold, or dispensed outside of this
State once in the possession of the importer;
(iii) prescription drugs imported under the
program are pure, unadulterated, potent, and safe;
(iv) the program does not put consumers at a
higher health and safety risk than if the consumer did
not participate; and
(v) the program provides cost savings to the State
on imported prescription drugs.
Section 65. Notification of federal approval. Upon receipt
of federal approval of the program, the Department shall
notify the President of the Senate, the Speaker of the House of
Representatives, and the relevant committees of the Senate and
the House of Representatives. After approval is received and
before the start of the next regular session of the General
Assembly in which the proposal could be funded, the Department
shall submit to all parties a proposal for program
implementation and program funding.

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Section 70. Rulemaking. The Department shall adopt rules
necessary to implement this Act.
Section 99. Effective date. This Act takes effect upon
becoming law.