Arizona 2024 Regular Session

Arizona Senate Bill SB1251 Compare Versions

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

Old	New	Differences
1	1	REFERENCE TITLE: 340B drugs; covered entities; distribution State of Arizona Senate Fifty-sixth Legislature Second Regular Session 2024 SB 1251 Introduced by Senators Shope: Shamp An Act amending title 32, chapter 18, article 3, Arizona Revised Statutes, by adding section 32-1980; relating to the Arizona state board of pharmacy. (TEXT OF BILL BEGINS ON NEXT PAGE)
2	2
3	3
4	4
5	5
6	6
7	7
8	8
9	9	REFERENCE TITLE: 340B drugs; covered entities; distribution
10	10	State of Arizona Senate Fifty-sixth Legislature Second Regular Session 2024
11	11	SB 1251
12	12	Introduced by Senators Shope: Shamp
13	13
14	14	REFERENCE TITLE: 340B drugs; covered entities; distribution
15	15
16	16
17	17
18	18
19	19
20	20
21	21
22	22
23	23
24	24	State of Arizona
25	25
26	26	Senate
27	27
28	28	Fifty-sixth Legislature
29	29
30	30	Second Regular Session
31	31
32	32	2024
33	33
34	34
35	35
36	36
37	37
38	38
39	39
40	40	SB 1251
41	41
42	42
43	43
44	44	Introduced by
45	45
46	46	Senators Shope: Shamp
47	47
48	48
49	49
50	50
51	51
52	52
53	53
54	54
55	55
56	56
57	57
58	58
59	59
60	60
61	61
62	62
63	63
64	64	An Act
65	65
66	66
67	67
68	68	amending title 32, chapter 18, article 3, Arizona Revised Statutes, by adding section 32-1980; relating to the Arizona state board of pharmacy.
69	69
70	70
71	71
72	72
73	73
74	74	(TEXT OF BILL BEGINS ON NEXT PAGE)
75	75
76	76
77	77
78	78	Be it enacted by the Legislature of the State of Arizona: Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1980, to read: START_STATUTE32-1980. 340B drug distribution; interference prohibited; enforcement; definitions A. A manufacturer, repackager, third-party logistics provider or wholesale distributor, or an agent or affiliate of a manufacturer, repackager, third-party logistics provider or wholesale distributor, may not, either directly or indirectly, do either of the following: 1. Deny, restrict, prohibit, discriminate against or otherwise limit the acquisition of a 340B drug by or delivery of a 340B drug to a 340B covered entity, a pharmacy contracted with a 340B covered entity or a location authorized by the 340B covered entity to receive 340B drugs unless the receipt of the 340B drug is prohibited by the United States department of health and human services. 2. Require a 340B covered entity to submit any claims or utilization data as a condition for allowing the acquisition of a 340B drug by or delivery of a 340B drug to a 340B covered entity unless the claims or utilization data sharing is required by the United States department of health and human services. B. The board shall investigate any complaint of a violation of subsection A of this section by a person or entity that is permitted or licensed by the board and may impose discipline, suspension or revocation on the permitted or licensed person or entity as provided in this chapter. C. A violation of subsection A of this section is subject to enforcement by the attorney general as an unlawful practice pursuant to section 44-1522. Each package of 340B drugs that is determined to be subject to a prohibited act under subsection A of this section constitutes a separate violation. D. The board may adopt rules to implement this section. E. This section does not create a private cause of action against a person or entity acting in violation of subsection A of this section. F. This section may not be construed or applied to be less restrictive than any federal law as to any person or entity regulated by this section. Limited distribution of a drug required under 21 United States Code section 355-1 is not a violation of this section. Limited distribution of a controlled substance pursuant to a state or federal law or court order is not a violation of this section. This section may not be construed or applied to be in conflict with either: 1. Any applicable federal law and regulations adopted pursuant to that law. 2. Any other law of this state if the state law is compatible with the applicable federal law. G. For the purposes of this section: 1. "Repackager" has the same meaning prescribed in 21 United States Code section 360eee(16). 2. "340B covered entity" has the same meaning prescribed in section 20-3341. 3. "340B drug" means a drug that is all of the following: (a) A covered outpatient drug within the meaning of 42 United States Code section 256b. (b) Has been subject to any offer for reduced prices by a manufacturer under 42 United States Code section 256b(a)(1). (c) Is purchased by a 340B covered entity, including that it would have been purchased but for the restriction or limitation described in subsection A of this section. 4. "Wholesale distributor" has the meaning prescribed in 21 United States Code section 360eee.END_STATUTE
79	79
80	80	Be it enacted by the Legislature of the State of Arizona:
81	81
82	82	Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1980, to read:
83	83
84	84	START_STATUTE32-1980. 340B drug distribution; interference prohibited; enforcement; definitions
85	85
86	86	A. A manufacturer, repackager, third-party logistics provider or wholesale distributor, or an agent or affiliate of a manufacturer, repackager, third-party logistics provider or wholesale distributor, may not, either directly or indirectly, do either of the following:
87	87
88	88	1. Deny, restrict, prohibit, discriminate against or otherwise limit the acquisition of a 340B drug by or delivery of a 340B drug to a 340B covered entity, a pharmacy contracted with a 340B covered entity or a location authorized by the 340B covered entity to receive 340B drugs unless the receipt of the 340B drug is prohibited by the United States department of health and human services.
89	89
90	90	2. Require a 340B covered entity to submit any claims or utilization data as a condition for allowing the acquisition of a 340B drug by or delivery of a 340B drug to a 340B covered entity unless the claims or utilization data sharing is required by the United States department of health and human services.
91	91
92	92	B. The board shall investigate any complaint of a violation of subsection A of this section by a person or entity that is permitted or licensed by the board and may impose discipline, suspension or revocation on the permitted or licensed person or entity as provided in this chapter.
93	93
94	94	C. A violation of subsection A of this section is subject to enforcement by the attorney general as an unlawful practice pursuant to section 44-1522. Each package of 340B drugs that is determined to be subject to a prohibited act under subsection A of this section constitutes a separate violation.
95	95
96	96	D. The board may adopt rules to implement this section.
97	97
98	98	E. This section does not create a private cause of action against a person or entity acting in violation of subsection A of this section.
99	99
100	100	F. This section may not be construed or applied to be less restrictive than any federal law as to any person or entity regulated by this section. Limited distribution of a drug required under 21 United States Code section 355-1 is not a violation of this section. Limited distribution of a controlled substance pursuant to a state or federal law or court order is not a violation of this section. This section may not be construed or applied to be in conflict with either:
101	101
102	102	1. Any applicable federal law and regulations adopted pursuant to that law.
103	103
104	104	2. Any other law of this state if the state law is compatible with the applicable federal law.
105	105
106	106	G. For the purposes of this section:
107	107
108	108	1. "Repackager" has the same meaning prescribed in 21 United States Code section 360eee(16).
109	109
110	110	2. "340B covered entity" has the same meaning prescribed in section 20-3341.
111	111
112	112	3. "340B drug" means a drug that is all of the following:
113	113
114	114	(a) A covered outpatient drug within the meaning of 42 United States Code section 256b.
115	115
116	116	(b) Has been subject to any offer for reduced prices by a manufacturer under 42 United States Code section 256b(a)(1).
117	117
118	118	(c) Is purchased by a 340B covered entity, including that it would have been purchased but for the restriction or limitation described in subsection A of this section.
119	119
120	120	4. "Wholesale distributor" has the meaning prescribed in 21 United States Code section 360eee.END_STATUTE