Illinois 2025-2026 Regular Session

Illinois House Bill HB3350 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB3350 Introduced , by Rep. Anna Moeller 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 09643 BAB 19709 b A BILL FOR 104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB3350 Introduced , by Rep. Anna Moeller 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 09643 BAB 19709 b LRB104 09643 BAB 19709 b A BILL FOR
2	2	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB3350 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
3	3	New Act New Act
4	4	New Act
5	5	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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11	11	1 AN ACT concerning regulation.
12	12	2 Be it enacted by the People of the State of Illinois,
13	13	3 represented in the General Assembly:
14	14	4 Section 1. Short title. This Act may be cited as the
15	15	5 Patient Access to Pharmacy Protection Act.
16	16	6 Section 5. Findings. The General Assembly finds that:
17	17	7 (a) It is within the traditional authority of the State to
18	18	8 regulate the acquisition and delivery of drugs to pharmacies
19	19	9 and providers.
20	20	10 (b) Drug manufacturers are impeding access to lifesaving
21	21	11 drugs to Illinois residents, especially those in rural and
22	22	12 medically underserved communities, by limiting or placing
23	23	13 conditions on acquisition and delivery of drugs purchased
24	24	14 through the federal 340B drug discount program by 340B covered
25	25	15 entities that utilize contract pharmacies to distribute 340B
26	26	16 drugs.
27	27	17 (c) The federal 340B statute is silent on distribution of
28	28	18 340B-acquired drugs to 340B covered entities and their
29	29	19 contract pharmacy partners.
30	30	20 (d) The State's compelling interest in preserving and
31	31	21 improving access to health care services requires it to ensure
32	32	22 that 340B covered entities continue to be allowed to contract
33	33	23 with pharmacies to receive 340B drugs and dispense them to the
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37	37	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB3350 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
38	38	New Act New Act
39	39	New Act
40	40	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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43	43	A BILL FOR
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68	68	1 patients of 340B covered entities in accordance with federal
69	69	2 law.
70	70	3 (e) That addressing accessibility of these life-saving
71	71	4 medications is a matter of health, safety, and welfare for the
72	72	5 people of the State of Illinois.
73	73	6 Section 10. Definitions. As used in this Act:
74	74	7 "340B drug discount program" means the program established
75	75	8 under Section 340B of the federal Public Health Service Act,
76	76	9 42 U.S.C. 256b.
77	77	10 "340B contract pharmacy" means any pharmacy that is under
78	78	11 contract with a 340B covered entity to dispense 340B drugs on
79	79	12 behalf of the 340B covered entity and is either (i) located in
80	80	13 Illinois and qualifies as a pharmacy under Section 3 of the
81	81	14 Pharmacy Practice Act; or (ii) is located in a state,
82	82	15 commonwealth, or territory of the United States, other than
83	83	16 Illinois, and dispenses 340B drugs on behalf of the 340B
84	84	17 covered entity.
85	85	18 "340B covered entity" means an entity in Illinois that
86	86	19 qualifies as a covered entity under Section 340B of the
87	87	20 federal Public Health Service Act, 42 U.S.C. 256b(a)(4).
88	88	21 "340B drug" means a drug that has been subject to any offer
89	89	22 for reduced prices by a manufacturer pursuant to 42 U.S.C.
90	90	23 256b and is purchased by a 340B covered entity.
91	91	24 "Department" means the Department of Financial and
92	92	25 Professional Regulation.
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103	103	1 "Manufacturer" has the meaning given to that term in the
104	104	2 Wholesale Drug Distribution Licensing Act.
105	105	3 "Person" means and includes a natural person, partnership,
106	106	4 association, corporation, or any other legal business entity,
107	107	5 but does not include any federal or State government entity or
108	108	6 body.
109	109	7 "Secretary" means the Secretary of Financial and
110	110	8 Professional Regulation.
111	111	9 Section 15. Protection of patient access to pharmacy.
112	112	10 (a) No person, including a pharmaceutical manufacturer,
113	113	11 may deny, restrict, prohibit, condition, or otherwise
114	114	12 interfere with, either directly or indirectly, the acquisition
115	115	13 of a 340B drug by, or delivery of a 340B drug to, a 340B
116	116	14 covered entity or a 340B contract pharmacy authorized to
117	117	15 receive 340B drugs on behalf of the 340B covered entity unless
118	118	16 such receipt is prohibited by federal law.
119	119	17 (b) No person, including a pharmaceutical manufacturer,
120	120	18 may impose any restriction on the ability of a 340B covered
121	121	19 entity to contract with or designate a 340B contract pharmacy
122	122	20 including restrictions relating to the number, location,
123	123	21 ownership, or type of 340B contract pharmacy.
124	124	22 (c) No person, including a pharmaceutical manufacturer,
125	125	23 may require or compel a 340B covered entity or 340B contract
126	126	24 pharmacy to:
127	127	25 (1) submit or otherwise provide ingredient cost or
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138	138	1 pricing data pertinent to 340B drugs unless required by
139	139	2 State or federal law;
140	140	3 (2) institute requirements in any way relating to how
141	141	4 a 340B covered entity manages its inventory of 340B drugs
142	142	5 that are not required by a State or federal agency,
143	143	6 including requirements relating to the frequency or scope
144	144	7 of audits of inventory management systems of a 340B
145	145	8 covered entity or a 340B contract pharmacy; or
146	146	9 (3) submit data or information that is not required by
147	147	10 State or federal law as a condition for a 340B covered
148	148	11 entity, its 340B contract pharmacy, or a location
149	149	12 otherwise authorized by a 340B covered entity to receive
150	150	13 340B drugs.
151	151	14 (d) Each individual saleable unit, as such term is defined
152	152	15 in 21 U.S.C. 360eee-11, of 340B drugs that is subject to a
153	153	16 prohibited act in subsections (a) and (b) shall constitute a
154	154	17 separate violation of this Act. Each communication received by
155	155	18 a 340B covered entity or 340B contract pharmacy in violation
156	156	19 of subsection (c) shall constitute a separate violation of
157	157	20 this Act.
158	158	21 Section 20. Enforcement.
159	159	22 (a) The Department is authorized to enforce this Act and
160	160	23 investigate possible violations of this Act by any person,
161	161	24 including a pharmaceutical manufacturer, including, but not
162	162	25 limited to, the issuance of subpoenas to:
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173	173	1 (1) require the person, including a pharmaceutical
174	174	2 manufacturer, to file a statement or report or answer
175	175	3 interrogatories in writing as to all information relevant
176	176	4 to the alleged violations;
177	177	5 (2) examine under oath any person, including a
178	178	6 pharmaceutical manufacturer, who possesses knowledge or
179	179	7 information directly related to the alleged violations; or
180	180	8 (3) examine any record, book, document, account, or
181	181	9 paper necessary to investigate the alleged violation.
182	182	10 (b) If the Department determines that there is a reason to
183	183	11 believe that any person, including a pharmaceutical
184	184	12 manufacturer, has violated this Act, the Secretary may, in the
185	185	13 name of the People of the State of Illinois, through the
186	186	14 Attorney General of the State of Illinois or the State's
187	187	15 Attorney of a county in which the action is brought, bring an
188	188	16 action to obtain, and a court may order:
189	189	17 (1) temporary, preliminary, or permanent injunctive
190	190	18 relief for any act, policy, or practice that violates this
191	191	19 Act;
192	192	20 (2) money damages to be paid to the 340B covered
193	193	21 entity as a result of the violation of this Section;
194	194	22 (3) the assessment of a civil penalty of up to $10,000
195	195	23 for each violation of Section 15; or
196	196	24 (4) any other relief.
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198	198	26 (c) Whenever a 340B covered entity or 340B contract
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209	209	1 pharmacy has reason to believe that any person, including a
210	210	2 pharmaceutical manufacturer, has violated Section 15, a 340B
211	211	3 covered entity or 340B contract pharmacy may bring a civil
212	212	4 action to obtain, and a court may order:
213	213	5 (1) temporary, preliminary, or permanent injunctive
214	214	6 relief for any act, policy, or practice that violates this
215	215	7 Act;
216	216	8 (2) money damages to be paid to the 340B covered
217	217	9 entity as a result of the violation of this Section;
218	218	10 (3) the assessment of a civil penalty of up to $10,000
219	219	11 for each violation of Section 15;
220	220	12 (4) reimbursement for the costs and reasonable
221	221	13 attorney's fees incurred in bringing the action; or
222	222	14 (5) any other relief.
223	223	15 (d) The actions described in subsections (b) and (c) may
224	224	16 be consolidated or combined if a court believes that an action
225	225	17 in such form is in the best interests of judicial economy. If
226	226	18 an action brought under subsection (b) involves the same or
227	227	19 similar allegations as an action brought under subsection (c),
228	228	20 then the actions may be combined.
229	229	21 Section 25. Preemption.
230	230	22 (a) Nothing in this Act shall be construed or applied to be
231	231	23 less restrictive than federal law for a person regulated by
232	232	24 this Act.
233	233	25 (b) Nothing in this Act shall be construed or applied in a
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244	244	1 manner that would conflict with:
245	245	2 (1) applicable federal law; or
246	246	3 (2) other laws of this State if the State law is
247	247	4 compatible with applicable federal law.
248	248	5 (c) Limited distribution of a drug required under 21
249	249	6 U.S.C. 355-1 may not to be construed as a violation of this
250	250	7 Act.
251	251	8 Section 97. Severability. If any provision of this Act or
252	252	9 its application to any person or circumstance is held invalid,
253	253	10 the invalidity of that provision or application does not
254	254	11 affect other provisions or applications of this Act that can
255	255	12 be given effect without the invalid provision or application.
256	256	13 Each paragraph defining "340B contract pharmacy" in Section 10
257	257	14 is severable.
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