Illinois General Assembly - Full Text of HB3310
Illinois General Assembly

  Bills & Resolutions  
  Compiled Statutes  
  Public Acts  
  Legislative Reports  
  IL Constitution  
  Legislative Guide  
  Legislative Glossary  

 Search By Number
 (example: HB0001)
Search Tips

Search By Keyword

Full Text of HB3310  103rd General Assembly




State of Illinois
2023 and 2024


Introduced 2/17/2023, by Rep. Joe C. Sosnowski


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.

LRB103 30128 CPF 56552 b





HB3310LRB103 30128 CPF 56552 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 1. Short title. This Act may be cited as the
5Canadian Prescription Drug Importation Act.
6    Section 3. Findings. The General Assembly finds:
7        (1) United States citizens pay some of the highest
8    prices for prescription drugs in the world, and the
9    Canadian government estimates that United States consumers
10    pay twice as much as Canadians for patented prescription
11    drugs and 20% more for generics.
12        (2) Under the United States Food and Drug
13    Administration's discretion not to enforce the law,
14    individual patients may import from Canada a 90-day supply
15    of prescription drugs that are less expensive than drugs
16    licensed by the Food and Drug Administration in the United
17    States.
18        (3) Individual importation via the Internet increases
19    consumer health and safety risks because many Internet
20    pharmacies are not licensed in Canada, and it is difficult
21    to verify the validity, reputation, actual identity, and
22    pharmacy practices of online pharmacies outside of the
23    United States.



HB3310- 2 -LRB103 30128 CPF 56552 b

1        (4) The United States allows patients to travel to
2    other countries for surgeries and other high-risk medical
3    treatments without regulating that activity, and insurers
4    sometimes facilitate and pay for treatments outside of the
5    United States.
6        (5) The United States Food and Drug Administration
7    estimates that currently 40% of finished prescription drug
8    products are produced outside of the United States, and
9    80% of raw products for United States pharmaceutical
10    manufacturing come from outside the United States.
11        (6) The United States Food and Drug Administration
12    recently signed reciprocity agreements with European Union
13    regulators to accept the results of European Union
14    inspections of pharmaceutical manufacturing plants. Since
15    1973, the United States Food and Drug Administration has
16    had in place a Memorandum of Understanding for regulatory
17    cooperation around pharmaceuticals with the Canadian
18    regulatory authorities.
19        (7) Canada has a rigorous regulatory system to license
20    prescription drugs that is considered to be on par with
21    the United States licensing system.
22        (8) The enactment of Title II of the federal Drug
23    Quality and Security Act (P.L. 113-54) has resulted in
24    improvements in drug security and safety by implementing a
25    pharmaceutical track-and-trace system that could be
26    leveraged for the safe importation of pharmaceuticals.



HB3310- 3 -LRB103 30128 CPF 56552 b

1        (9) The Secretary of the United States Department of
2    Health and Human Services may certify a prescription drug
3    reimportation program that is safe and saves consumers
4    money.
5        (10) The State can ensure that wholesale importation
6    of prescription drugs from Canada into the State will be
7    safe and cost-effective for State consumers.
8    Section 5. Program established. The Department of Public
9Health shall establish the Canadian Prescription Drug
10Importation Program for the importation from Canada of safe
11and effective prescription drugs that have the highest
12potential for cost savings to the State.
13    Section 10. Definitions. As used in this Act:
14    "Canadian supplier" means a manufacturer, wholesale
15distributor, or pharmacy appropriately licensed or permitted
16under Canadian law to manufacture, distribute, or dispense
17prescription drugs.
18    "County health department" means a health care facility
19established under Division 5-25 of the Counties Code.
20    "Department" means the Department of Public Health.
21    "Drug" or "prescription drug" has the same meaning as
22"drugs" in Section 1 of the Pharmacy Practice Act.
23    "Federal act" means the Federal Food, Drug, and Cosmetic
24Act as amended by the federal Drug Quality and Security Act.



HB3310- 4 -LRB103 30128 CPF 56552 b

1    "Free clinic" means a free medical clinic as defined in
2subsection (b) of Section 30 of the Good Samaritan Act.
3    "Medicaid pharmacy" means a pharmacy licensed under the
4Pharmacy Practice Act that has a Medicaid provider agreement
5in effect with the State and is in good standing with the
7    "Pharmacist" means a person who holds an active and
8unencumbered license to practice pharmacy under the Pharmacy
9Practice Act.
10    "Program" means the Canadian Prescription Drug Importation
11Program created under this Act.
12    "Track-and-trace" means the product-tracing process for
13the components of the pharmaceutical distribution supply chain
14as described in Title II of the federal Drug Quality and
15Security Act.
16    "Vendor" means the entity contracted by the Department to
17manage specified functions of the program.
18    Section 15. Importation process.
19    (a) The Department shall contract with a vendor to provide
20services under the program.
21    (b) On or before December 1, 2023, and on or before
22December 1 of each year thereafter, the vendor shall develop a
23wholesale prescription drug importation list identifying the
24prescription drugs that have the highest potential for cost
25savings to the State. In developing the list, the vendor shall



HB3310- 5 -LRB103 30128 CPF 56552 b

1consider, at a minimum, which prescription drugs will provide
2the greatest cost savings to State programs, including
3prescription drugs for which there are shortages, specialty
4prescription drugs, and high-volume prescription drugs. The
5Department, in consultation with the federal department, shall
6review the wholesale prescription drug importation list every
73 months to ensure that it continues to meet the requirements
8of the programs and may direct the vendor to revise the list as
10    (c) The vendor shall identify Canadian suppliers that are
11in full compliance with relevant Canadian federal and
12provincial laws and regulations and the federal act and who
13have agreed to export drugs identified on the list at prices
14that will provide cost savings to the State. The vendor must
15verify that such Canadian suppliers meet all of the
16requirements of the program while meeting or exceeding the
17federal and State track-and-trace laws and regulations.
18    (d) The vendor shall contract with such eligible Canadian
19suppliers, or facilitate contracts between eligible importers
20and Canadian suppliers, to import drugs under the program.
21    (e) The vendor shall maintain a list of all registered
22importers that participate in the program.
23    (f) The vendor shall ensure compliance with Title II of
24the federal Drug Quality and Security Act by all suppliers,
25importers and other distributors, and participants in the



HB3310- 6 -LRB103 30128 CPF 56552 b

1    (g) The vendor shall assist the Department in the
2preparation of the annual report required by Section 60 of
3this Act including the timely provision of any information
4requested by the Department.
5    (h) The vendor shall provide an annual financial audit of
6its operations to the Department as required by the
7Department. The vendor shall also provide quarterly financial
8reports specific to the program and shall include information
9on the performance of its subcontractors and vendors. The
10Department shall determine the format and contents of the
12    Section 20. Bond requirement. The Department shall require
13a bond from the vendor to mitigate the financial consequences
14of potential acts of malfeasance or misfeasance or fraudulent
15or dishonest acts committed by the vendor, any employees of
16the vendor, or its subcontractors.
17    Section 25. Eligible prescription drugs. Eligible
18importers, as described in Section 35 of this Act, may import a
19drug from an eligible Canadian supplier, as described in
20Section 30 of this Act, if:
21        (1) the drug meets the United States Food and Drug
22    Administration's standards related to safety,
23    effectiveness, misbranding, and adulteration;
24        (2) importing the drug would not violate federal



HB3310- 7 -LRB103 30128 CPF 56552 b

1    patent laws;
2        (3) importing the drug is expected to generate cost
3    savings; and
4        (4) the drug is not:
5            (i) a controlled substance as defined in 21 U.S.C.
6        802;
7            (ii) a biological product as defined in 42 U.S.C.
8        262;
9            (iii) an infused drug;
10            (iv) an intravenously injected drug;
11            (v) a drug that is inhaled during surgery; or
12            (vi) a drug that is a parenteral drug, the
13        importation of which is determined by the United
14        States Secretary of Health and Human Services to pose
15        a threat to the public health.
16    Section 30. Eligible Canadian suppliers. A Canadian
17supplier may export prescription drugs into this State under
18the program if the supplier:
19        (1) is in full compliance with relevant Canadian
20    federal and provincial laws and regulations;
21        (2) is identified by the vendor as eligible to
22    participate in the program; and
23        (3) submits an attestation that the supplier has a
24    registered agent in the United States, including the name
25    and United States address of the registered agent.



HB3310- 8 -LRB103 30128 CPF 56552 b

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



HB3310- 9 -LRB103 30128 CPF 56552 b

1    contract with a residential treatment facility, or
2    "facility" as defined in the Specialized Mental Health
3    Rehabilitation Act of 2013 for dispensing to patients
4    treated in such facility.
5    Section 40. Distribution requirements. Eligible Canadian
6suppliers and eligible importers participating under the
8        (1) must comply with the tracking and tracing
9    requirements of 21 U.S.C. 360; and
10        (2) may not distribute, dispense, or sell prescription
11    drugs imported under the program outside of the State.
12    Section 45. Federal approval. On or before July 1, 2023,
13the Department shall submit a request to the United States
14Secretary of Health and Human Services for approval of the
15program under paragraph (1) of 21 U.S.C. 384. The Department
16shall begin operating the program within 6 months after
17receiving such approval. The request must, at a minimum:
18        (1) describe the Department's plan for operating the
19    program;
20        (2) demonstrate how the prescription drugs imported
21    into this State under the program will meet the applicable
22    federal and State standards for safety and effectiveness;
23        (3) demonstrate how the drugs imported into this State
24    under the program will comply with federal tracing



HB3310- 10 -LRB103 30128 CPF 56552 b

1    procedures;
2        (4) include a list of proposed prescription drugs that
3    have the highest potential for cost savings to the State
4    through importation at the time that the request is
5    submitted;
6        (5) estimate the total cost savings attributable to
7    the program;
8        (6) provide the costs of program implementation to the
9    State; and
10        (7) include a list of potential Canadian suppliers
11    from which the State would import drugs and demonstrate
12    that the suppliers are in full compliance with relevant
13    Canadian federal and provincial laws and regulations as
14    well as all applicable federal and State laws and
15    regulations.
16    Section 50. Prescription drug supply chain documentation.
17    (a) The vendor shall ensure the safety and quality of
18drugs imported under the program. The vendor shall:
19        (1) for an initial imported shipment of a specific
20    drug by an importer, ensure that each batch of the drug in
21    the shipment is statistically sampled and tested for
22    authenticity and degradation in a manner consistent with
23    the federal act;
24        (2) for every subsequent imported shipment of that
25    drug by that importer, ensure that a statistically valid



HB3310- 11 -LRB103 30128 CPF 56552 b

1    sample of the shipment is tested for authenticity and
2    degradation in a manner consistent with the federal act;
3        (3) certify that the drug:
4            (i) is approved for marketing in the United States
5        and is not adulterated or misbranded; and
6            (ii) meets all of the labeling requirements under
7        21 U.S.C. 352;
8        (4) maintain qualified laboratory records, including
9    complete data derived from all tests necessary to ensure
10    that the drug is in compliance with the requirements of
11    this Section.
12        (5) maintain documentation demonstrating that the
13    testing required by this Section was conducted at a
14    qualified laboratory in accordance with the federal act
15    and any other applicable federal and State laws and
16    regulations governing laboratory qualifications.
17    (b) All testing required by this Section must be conducted
18in a qualified laboratory that meets the standards under the
19federal act and any other applicable federal and State laws
20and regulations governing laboratory qualifications for drug
22    (c) The vendor shall maintain information and
23documentation submitted under this Section for a period of at
24least 7 years.
25    (d) A participating importer must submit all of the
26following information to the vendor:



HB3310- 12 -LRB103 30128 CPF 56552 b

1        (1) the name and quantity of the active ingredient of
2    the drug;
3        (2) a description of the dosage form of the drug;
4        (3) the date on which the drug is received;
5        (4) the quantity of the drug that is received;
6        (5) the point of origin and destination of the drug;
7    and
8        (6) the price paid by the importer for the drug;
9    (e) A participating Canadian supplier must submit the
10following information and documentation to the vendor
11specifying all of the following:
12        (1) the original source of the drug, including:
13            (i) the name of the manufacturer of the drug;
14            (ii) the date on which the drug was manufactured;
15        and
16            (iii) the location including the country, state or
17        province, and city, where the drug was manufactured;
18        (2) the date on which the drug is shipped;
19        (3) the quantity of the drug that is shipped;
20        (4) the quantity of each lot of the drug originally
21    received and the source of the lot; and
22        (5) the lot or control number and the batch number
23    assigned to the drug by the manufacturer.
24    (f) The Department may require that the vendor collect any
25other information necessary to ensure the protection of the
26public health.



HB3310- 13 -LRB103 30128 CPF 56552 b

1    Section 55. Immediate suspension. The Department shall
2immediately suspend the importation of a specific drug or the
3importation of drugs by a specific importer if it discovers
4that any drug or activity is in violation of this Section or
5any federal or State law or regulation. The Department may
6revoke the suspension if, after conducting an investigation,
7it determines that the public is adequately protected from
8counterfeit or unsafe drugs being imported into this State.
9    Section 60. Annual report. On or before December 1 of each
10year, the Department shall submit a report to the Governor,
11the President of the Senate, and the Speaker of the House of
12Representatives on the operation of the program during the
13previous fiscal year. The report must include, at a minimum:
14        (1) a list of the prescription drugs that were
15    imported under the program;
16        (2) the number of participating entities;
17        (3) the number of prescriptions dispensed through the
18    program;
19        (4) the estimated cost savings during the previous
20    fiscal year and to date attributable to the program;
21        (5) a description of the methodology used to determine
22    which drugs should be included on the wholesale
23    prescription drug importation list; and
24        (6) documentation as to how the program ensures the



HB3310- 14 -LRB103 30128 CPF 56552 b

1    following that:
2            (i) Canadian suppliers participating in the
3        program are of high quality, high performance, and in
4        full compliance with relevant Canadian federal and
5        provincial laws and regulations as well as all federal
6        laws and regulations and State laws and rules;
7            (ii) prescription drugs imported under the program
8        are not shipped, sold, or dispensed outside of this
9        State once in the possession of the importer;
10            (iii) prescription drugs imported under the
11        program are pure, unadulterated, potent, and safe;
12            (iv) the program does not put consumers at a
13        higher health and safety risk than if the consumer did
14        not participate; and
15            (v) the program provides cost savings to the State
16        on imported prescription drugs.
17    Section 65. Notification of federal approval. Upon receipt
18of federal approval of the program, the Department shall
19notify the President of the Senate, the Speaker of the House of
20Representatives, and the relevant committees of the Senate and
21the House of Representatives. After approval is received and
22before the start of the next regular session of the General
23Assembly in which the proposal could be funded, the Department
24shall submit to all parties a proposal for program
25implementation and program funding.



HB3310- 15 -LRB103 30128 CPF 56552 b

1    Section 70. Rulemaking. The Department shall adopt rules
2necessary to implement this Act.
3    Section 99. Effective date. This Act takes effect upon
4becoming law.