Rhode Island 2025 Regular Session

Rhode Island Senate Bill S0482 Compare Versions

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

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5	5	2025 -- S 0482
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7	7	LC002044
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9	9	S T A T E O F R H O D E I S L A N D
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2025
12	12	____________
13	13
14	14	A N A C T
15	15	RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND
16	16	COSMETICS ACT
17	17	Introduced By: Senators Lauria, Valverde, Kallman, Murray, Felag, DiMario, Pearson,
18	18	Thompson, Urso, and Acosta
19	19	Date Introduced: February 26, 2025
20	20	Referred To: Senate Health & Human Services
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23	23	It is enacted by the General Assembly as follows:
24	24	SECTION 1. Section 21-31-16.1 of the General Laws in Chapter 21-31 entitled "Rhode 1
25	25	Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows: 2
26	26	21-31-16.1. Substitution of generic drugs and biological products Substitution of 3
27	27	generic drugs, biological products, devices and supplies, and therapeutically equivalent 4
28	28	products by a pharmacist. 5
29	29	(a) Drug product selection. The director shall permit substitution of less expensive generic, 6
30	30	chemical, or brand-name drugs and pharmaceuticals, excluding biological products, considered by 7
31	31	the director as therapeutically equivalent and interchangeable with specific, brand-name drugs and 8
32	32	pharmaceuticals, if they are found to be in compliance with § 21-31-16 and standards set forth by 9
33	33	the United States Food and Drug Administration under §§ 505 and 507 of the Federal Food, Drug, 10
34	34	and Cosmetic Act, 21 U.S.C. §§ 355 and 357. The director shall consider, but not be limited to, the 11
35	35	determination of the United States Food and Drug Administration, or its successor agency, as 12
36	36	published under §§ 505 and 507 of the Federal Food, Drug, and Cosmetic Act. The director shall 13
37	37	provide for the distribution of copies of lists of prescription drug products that the director deems, 14
38	38	after evaluation, not to be therapeutically equivalent, and revisions to the lists, among physicians 15
39	39	and pharmacists licensed and actively engaged in practice within the state, and other appropriate 16
40	40	individuals, and shall supply a copy to any person on request. The list shall be revised from time to 17
41	41	time so as to include new, pertinent information on approved prescription-drug products, reflecting 18
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45	45	current information as to standards for quality, safety, effectiveness, and therapeutic equivalence. 1
46	46	(b) The director shall provide a therapeutically equivalent product list, which is a list of 2
47	47	products that can be substituted for another specific product. (The products on the therapeutically 3
48	48	equivalent product list are outside of brand/generic switches or biological interchangeable 4
49	49	products.) 5
50	50	(1) The therapeutically equivalent product list shall provide the prescribed products' name, 6
51	51	dosage, directions, package size/quantity prescribed and the therapeutically equivalent product’s 7
52	52	name, dosage, directions, package size/quantity prescribed. 8
53	53	(2) Pharmacists utilizing the therapeutically equivalent product list shall document the 9
54	54	change on the prescription and notify the prescribing provider of the change within seven (7) 10
55	55	calendar days. 11
56	56	(3) Pharmacists shall not be mandated to utilize the therapeutically equivalent product list 12
57	57	nor are consumers required to accept a medication switch/substitution based on the therapeutically 13
58	58	equivalent product list. 14
59	59	(4) The therapeutically equivalent product list applies to initial starts or “first fills” as well 15
60	60	as those continuing care. 16
61	61	(5) The list shall be reviewed and revised periodically, but not less frequently than every 17
62	62	three (3) years to include new, pertinent information on approved prescription-drug products, 18
63	63	reflecting current information as to standards for quality, safety, effectiveness, and therapeutic 19
64	64	equivalence. 20
65	65	(6) The director shall consult representatives appointed by the Rhode Island Pharmacist's 21
66	66	Association (RIPA), Nurse Practitioner Alliance of Rhode Island (NPARI), and Rhode Island 22
67	67	Medical Society (RIMS) for review and or consultation of the interchange list. Each organization 23
68	68	shall have one appointed representative by their respective president or executive leadership. 24
69	69	(b)(c) Appropriations. The director shall provide necessary space, personnel, and material 25
70	70	to carry out the provisions of this section. 26
71	71	(c)(d) Liability. There shall be no civil liability incurred, and no cause of action of any 27
72	72	nature shall arise, against the director, designated agents, or employees, as a result of the listing or 28
73	73	omission of drugs or pharmaceuticals or biological products for product selection. 29
74	74	(d)(e) Annual reports. The director shall make annual reports to the general assembly by 30
75	75	February 10 of each year showing a list of approved prescription-drug products with therapeutic 31
76	76	equivalence and approved prescription interchangeable biological products, and an estimate of the 32
77	77	average savings to the general public. 33
78	78	(e)(f) Pharmacists. When a pharmacist dispenses a therapeutically equivalent drug product 34
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82	82	or interchangeable biological product, there shall be no additional liability imposed on the 1
83	83	prescriber who authorizes that product selection, or on the pharmacist dispensing the product 2
84	84	selection from a physician’s oral or written order. 3
85	85	(f)(g) Enforcement provisions. It is made the duty of the department of health, its agents 4
86	86	designated by the director of health, and of all peace officers within the state to enforce all 5
87	87	provisions of this section and of §§ 5-19.1-19, 5-37-18 — 5-37-18.2, and 21-31-3. 6
88	88	(g)(h) Biological-product selection. The director shall permit substitution of a less-7
89	89	expensive biological product, as defined in § 5-19.1-2, for a prescribed biological product only if 8
90	90	said less-expensive biological product is an interchangeable biological product as defined in § 5-9
91	91	19.1-2. The director shall maintain on the Rhode Island state department of health website, a link 10
92	92	to the current list of each biological product determined by the United States Food and Drug 11
93	93	Administration to be an interchangeable biological product. 12
94	94	(i) Device product selection. The director shall permit substitution of a less-expensive 13
95	95	device, or supply as defined in § 5-19.1-2, for a prescribed product only if said less-expensive 14
96	96	product is approved for the same indication, use, and if applicable, formulation. In the event that a 15
97	97	class of devices monitor differently (i.e. single reading vs continuous), the interchanged device 16
98	98	must monitor in the same fashion. The director shall maintain on the department of health website 17
99	99	a link to the current list of each product to be an interchangeable device or supply. Such examples 18
100	100	suitable for interchange include, but are not limited to, supplies and devices used to monitor 19
101	101	glucose, administer insulin or another pharmacologic product as determined by the director. 20
102	102	SECTION 2. This act shall take effect on January 1, 2026. 21
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109	109	EXPLANATION
110	110	BY THE LEGISLATIVE COUNCIL
111	111	OF
112	112	A N A C T
113	113	RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND
114	114	COSMETICS ACT
115	115	***
116	116	This act would amend the types of less expensive generic products which pharmacists may 1
117	117	prescribe to include "devices and supplies" and "therapeutically equivalent products" and would 2
118	118	require the director to provide a list of therapeutically equivalent products. 3
119	119	This act would take effect on January 1, 2026. 4
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