104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 SB2385 Introduced 2/7/2025, by Sen. David Koehler SYNOPSIS AS INTRODUCED: New Act Creates the Patient Access to Pharmacy Protection Act. Defines terms. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless such receipt is prohibited by federal law. Provides that no person, including a pharmaceutical manufacturer, may impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy including restrictions relating to the number, location, ownership, or type of 340B contract pharmacy. Provides that no person, including a pharmaceutical manufacturer, may require or compel a 340B covered entity or 340B contract pharmacy to submit or otherwise provide ingredient cost or pricing data pertinent to 340B drugs unless required by State or federal law; institute requirements in any way relating to how a 340B covered entity manages its inventory of 340B drugs that are not required by a State or federal agency, including requirements relating to the frequency or scope of audits of inventory management systems of a 340B covered entity or a 340B contract pharmacy; or submit data or information that is not required by State or federal law as a condition for a 340B covered entity, its 340B contract pharmacy, or a location otherwise authorized by a 340B covered entity to receive 340B drugs. Sets forth provisions concerning enforcement of this Act; preemption of this Act; and severability of this Act. Effective immediately. LRB104 09642 BAB 19708 b A BILL FOR 104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 SB2385 Introduced 2/7/2025, by Sen. David Koehler SYNOPSIS AS INTRODUCED: New Act New Act Creates the Patient Access to Pharmacy Protection Act. Defines terms. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless such receipt is prohibited by federal law. Provides that no person, including a pharmaceutical manufacturer, may impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy including restrictions relating to the number, location, ownership, or type of 340B contract pharmacy. Provides that no person, including a pharmaceutical manufacturer, may require or compel a 340B covered entity or 340B contract pharmacy to submit or otherwise provide ingredient cost or pricing data pertinent to 340B drugs unless required by State or federal law; institute requirements in any way relating to how a 340B covered entity manages its inventory of 340B drugs that are not required by a State or federal agency, including requirements relating to the frequency or scope of audits of inventory management systems of a 340B covered entity or a 340B contract pharmacy; or submit data or information that is not required by State or federal law as a condition for a 340B covered entity, its 340B contract pharmacy, or a location otherwise authorized by a 340B covered entity to receive 340B drugs. Sets forth provisions concerning enforcement of this Act; preemption of this Act; and severability of this Act. Effective immediately. LRB104 09642 BAB 19708 b LRB104 09642 BAB 19708 b A BILL FOR
104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 SB2385 Introduced 2/7/2025, by Sen. David Koehler SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Patient Access to Pharmacy Protection Act. Defines terms. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless such receipt is prohibited by federal law. Provides that no person, including a pharmaceutical manufacturer, may impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy including restrictions relating to the number, location, ownership, or type of 340B contract pharmacy. Provides that no person, including a pharmaceutical manufacturer, may require or compel a 340B covered entity or 340B contract pharmacy to submit or otherwise provide ingredient cost or pricing data pertinent to 340B drugs unless required by State or federal law; institute requirements in any way relating to how a 340B covered entity manages its inventory of 340B drugs that are not required by a State or federal agency, including requirements relating to the frequency or scope of audits of inventory management systems of a 340B covered entity or a 340B contract pharmacy; or submit data or information that is not required by State or federal law as a condition for a 340B covered entity, its 340B contract pharmacy, or a location otherwise authorized by a 340B covered entity to receive 340B drugs. Sets forth provisions concerning enforcement of this Act; preemption of this Act; and severability of this Act. Effective immediately.
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LRB104 09642 BAB 19708 b
A BILL FOR
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1 AN ACT concerning regulation.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 1. Short title. This Act may be cited as the
5 Patient Access to Pharmacy Protection Act.
6 Section 5. Findings. The General Assembly finds that:
7 (a) It is within the traditional authority of the State to
8 regulate the acquisition and delivery of drugs to pharmacies
9 and providers.
10 (b) Drug manufacturers are impeding access to lifesaving
11 drugs to Illinois residents, especially those in rural and
12 medically underserved communities, by limiting or placing
13 conditions on acquisition and delivery of drugs purchased
14 through the federal 340B drug discount program by 340B covered
15 entities that utilize contract pharmacies to distribute 340B
16 drugs.
17 (c) The federal 340B statute is silent on distribution of
18 340B-acquired drugs to 340B covered entities and their
19 contract pharmacy partners.
20 (d) The State's compelling interest in preserving and
21 improving access to health care services requires it to ensure
22 that 340B covered entities continue to be allowed to contract
23 with pharmacies to receive 340B drugs and dispense them to the
104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 SB2385 Introduced 2/7/2025, by Sen. David Koehler SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Patient Access to Pharmacy Protection Act. Defines terms. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless such receipt is prohibited by federal law. Provides that no person, including a pharmaceutical manufacturer, may impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy including restrictions relating to the number, location, ownership, or type of 340B contract pharmacy. Provides that no person, including a pharmaceutical manufacturer, may require or compel a 340B covered entity or 340B contract pharmacy to submit or otherwise provide ingredient cost or pricing data pertinent to 340B drugs unless required by State or federal law; institute requirements in any way relating to how a 340B covered entity manages its inventory of 340B drugs that are not required by a State or federal agency, including requirements relating to the frequency or scope of audits of inventory management systems of a 340B covered entity or a 340B contract pharmacy; or submit data or information that is not required by State or federal law as a condition for a 340B covered entity, its 340B contract pharmacy, or a location otherwise authorized by a 340B covered entity to receive 340B drugs. Sets forth provisions concerning enforcement of this Act; preemption of this Act; and severability of this Act. Effective immediately.
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LRB104 09642 BAB 19708 b
A BILL FOR
New Act
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1 patients of 340B covered entities in accordance with federal
2 law.
3 (e) That addressing accessibility of these life-saving
4 medications is a matter of health, safety, and welfare for the
5 people of the State of Illinois.
6 Section 10. Definitions. As used in this Act:
7 "340B drug discount program" means the program established
8 under Section 340B of the federal Public Health Service Act,
9 42 U.S.C. 256b.
10 "340B contract pharmacy" means any pharmacy that is under
11 contract with a 340B covered entity to dispense 340B drugs on
12 behalf of the 340B covered entity and is either (i) located in
13 Illinois and qualifies as a pharmacy under Section 3 of the
14 Pharmacy Practice Act; or (ii) is located in a state,
15 commonwealth, or territory of the United States, other than
16 Illinois, and dispenses 340B drugs on behalf of the 340B
17 covered entity.
18 "340B covered entity" means an entity in Illinois that
19 qualifies as a covered entity under Section 340B of the
20 federal Public Health Service Act, 42 U.S.C. 256b(a)(4).
21 "340B drug" means a drug that has been subject to any offer
22 for reduced prices by a manufacturer pursuant to 42 U.S.C.
23 256b and is purchased by a 340B covered entity.
24 "Department" means the Department of Financial and
25 Professional Regulation.
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1 "Manufacturer" has the meaning given to that term in the
2 Wholesale Drug Distribution Licensing Act.
3 "Person" means and includes a natural person, partnership,
4 association, corporation, or any other legal business entity,
5 but does not include any federal or State government entity or
6 body.
7 "Secretary" means the Secretary of Financial and
8 Professional Regulation.
9 Section 15. Protection of patient access to pharmacy.
10 (a) No person, including a pharmaceutical manufacturer,
11 may deny, restrict, prohibit, condition, or otherwise
12 interfere with, either directly or indirectly, the acquisition
13 of a 340B drug by, or delivery of a 340B drug to, a 340B
14 covered entity or a 340B contract pharmacy authorized to
15 receive 340B drugs on behalf of the 340B covered entity unless
16 such receipt is prohibited by federal law.
17 (b) No person, including a pharmaceutical manufacturer,
18 may impose any restriction on the ability of a 340B covered
19 entity to contract with or designate a 340B contract pharmacy
20 including restrictions relating to the number, location,
21 ownership, or type of 340B contract pharmacy.
22 (c) No person, including a pharmaceutical manufacturer,
23 may require or compel a 340B covered entity or 340B contract
24 pharmacy to:
25 (1) submit or otherwise provide ingredient cost or
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1 pricing data pertinent to 340B drugs unless required by
2 State or federal law;
3 (2) institute requirements in any way relating to how
4 a 340B covered entity manages its inventory of 340B drugs
5 that are not required by a State or federal agency,
6 including requirements relating to the frequency or scope
7 of audits of inventory management systems of a 340B
8 covered entity or a 340B contract pharmacy; or
9 (3) submit data or information that is not required by
10 State or federal law as a condition for a 340B covered
11 entity, its 340B contract pharmacy, or a location
12 otherwise authorized by a 340B covered entity to receive
13 340B drugs.
14 (d) Each individual saleable unit, as such term is defined
15 in 21 U.S.C. 360eee-11, of 340B drugs that is subject to a
16 prohibited act in subsections (a) and (b) shall constitute a
17 separate violation of this Act. Each communication received by
18 a 340B covered entity or 340B contract pharmacy in violation
19 of subsection (c) shall constitute a separate violation of
20 this Act.
21 Section 20. Enforcement.
22 (a) The Department is authorized to enforce this Act and
23 investigate possible violations of this Act by any person,
24 including a pharmaceutical manufacturer, including, but not
25 limited to, the issuance of subpoenas to:
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1 (1) require the person, including a pharmaceutical
2 manufacturer, to file a statement or report or answer
3 interrogatories in writing as to all information relevant
4 to the alleged violations;
5 (2) examine under oath any person, including a
6 pharmaceutical manufacturer, who possesses knowledge or
7 information directly related to the alleged violations; or
8 (3) examine any record, book, document, account, or
9 paper necessary to investigate the alleged violation.
10 (b) If the Department determines that there is a reason to
11 believe that any person, including a pharmaceutical
12 manufacturer, has violated this Act, the Secretary may, in the
13 name of the People of the State of Illinois, through the
14 Attorney General of the State of Illinois or the State's
15 Attorney of a county in which the action is brought, bring an
16 action to obtain, and a court may order:
17 (1) temporary, preliminary, or permanent injunctive
18 relief for any act, policy, or practice that violates this
19 Act;
20 (2) money damages to be paid to the 340B covered
21 entity as a result of the violation of this Section;
22 (3) the assessment of a civil penalty of up to $10,000
23 for each violation of Section 15; or
24 (4) any other relief.
25
26 (c) Whenever a 340B covered entity or 340B contract
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1 pharmacy has reason to believe that any person, including a
2 pharmaceutical manufacturer, has violated Section 15, a 340B
3 covered entity or 340B contract pharmacy may bring a civil
4 action to obtain, and a court may order:
5 (1) temporary, preliminary, or permanent injunctive
6 relief for any act, policy, or practice that violates this
7 Act;
8 (2) money damages to be paid to the 340B covered
9 entity as a result of the violation of this Section;
10 (3) the assessment of a civil penalty of up to $10,000
11 for each violation of Section 15;
12 (4) reimbursement for the costs and reasonable
13 attorney's fees incurred in bringing the action; or
14 (5) any other relief.
15 (d) The actions described in subsections (b) and (c) may
16 be consolidated or combined if a court believes that an action
17 in such form is in the best interests of judicial economy. If
18 an action brought under subsection (b) involves the same or
19 similar allegations as an action brought under subsection (c),
20 then the actions may be combined.
21 Section 25. Preemption.
22 (a) Nothing in this Act shall be construed or applied to be
23 less restrictive than federal law for a person regulated by
24 this Act.
25 (b) Nothing in this Act shall be construed or applied in a
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1 manner that would conflict with:
2 (1) applicable federal law; or
3 (2) other laws of this State if the State law is
4 compatible with applicable federal law.
5 (c) Limited distribution of a drug required under 21
6 U.S.C. 355-1 may not to be construed as a violation of this
7 Act.
8 Section 97. Severability. If any provision of this Act or
9 its application to any person or circumstance is held invalid,
10 the invalidity of that provision or application does not
11 affect other provisions or applications of this Act that can
12 be given effect without the invalid provision or application.
13 Each paragraph defining "340B contract pharmacy" in Section 10
14 is severable.
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