2025 -- H 5855

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LC001847

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2025

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A N   A C T

RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

     Introduced By: Representatives McGaw, Edwards, Giraldo, Cotter, Handy, Boylan,
Furtado, Caldwell, Stewart, and Voas

     Date Introduced: February 28, 2025

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Section 21-31-16.1 of the General Laws in Chapter 21-31 entitled "Rhode

Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

     21-31-16.1. Substitution of generic drugs and biological products Substitution of

generic drugs, biological products, devices and supplies, and therapeutically equivalent

products by a pharmacist.

     (a) Drug product selection. The director shall permit substitution of less expensive generic,

chemical, or brand-name drugs and pharmaceuticals, excluding biological products, considered by

the director as therapeutically equivalent and interchangeable with specific, brand-name drugs and

pharmaceuticals, if they are found to be in compliance with § 21-31-16 and standards set forth by

the United States Food and Drug Administration under §§ 505 and 507 of the Federal Food, Drug,

and Cosmetic Act, 21 U.S.C. §§ 355 and 357. The director shall consider, but not be limited to, the

determination of the United States Food and Drug Administration, or its successor agency, as

published under §§ 505 and 507 of the Federal Food, Drug, and Cosmetic Act. The director shall

provide for the distribution of copies of lists of prescription drug products that the director deems,

after evaluation, not to be therapeutically equivalent, and revisions to the lists, among physicians

and pharmacists licensed and actively engaged in practice within the state, and other appropriate

individuals, and shall supply a copy to any person on request. The list shall be revised from time to

time so as to include new, pertinent information on approved prescription-drug products, reflecting

current information as to standards for quality, safety, effectiveness, and therapeutic equivalence.

     (b) The director shall provide a therapeutically equivalent product list, which is a list of

products that can be substituted for another specific product. (The products on the therapeutically

equivalent product list are outside of brand/generic switches or biological interchangeable

products.)

     (1) The therapeutically equivalent product list shall provide the prescribed products' name,

dosage, directions, package size/quantity prescribed and the therapeutically equivalent product’s

name, dosage, directions, package size/quantity prescribed.

     (2) Pharmacists utilizing the therapeutically equivalent product list shall document the

change on the prescription and notify the prescribing provider of the change within seven (7)

calendar days.

     (3) Pharmacists shall not be mandated to utilize the therapeutically equivalent product list

nor are consumers required to accept a medication switch/substitution based on the therapeutically

equivalent product list.

     (4) The therapeutically equivalent product list applies to initial starts or “first fills” as well

as those continuing care.

     (5) The list shall be reviewed and revised periodically, but not less frequently than every

three (3) years to include new, pertinent information on approved prescription-drug products,

reflecting current information as to standards for quality, safety, effectiveness, and therapeutic

equivalence.

     (6) The director shall consult representatives appointed by the Rhode Island Pharmacist's

Association (RIPA), Nurse Practitioner Alliance of Rhode Island (NPARI), and Rhode Island

Medical Society (RIMS) for review and or consultation of the interchange list. Each organization

shall have one appointed representative by their respective president or executive leadership.

     (b)(c) Appropriations. The director shall provide necessary space, personnel, and material

to carry out the provisions of this section.

     (c)(d) Liability. There shall be no civil liability incurred, and no cause of action of any

nature shall arise, against the director, designated agents, or employees, as a result of the listing or

omission of drugs or pharmaceuticals or biological products for product selection.

     (d)(e) Annual reports. The director shall make annual reports to the general assembly by

February 10 of each year showing a list of approved prescription-drug products with therapeutic

equivalence and approved prescription interchangeable biological products, and an estimate of the

average savings to the general public.

     (e)(f) Pharmacists. When a pharmacist dispenses a therapeutically equivalent drug product

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or interchangeable biological product, there shall be no additional liability imposed on the

prescriber who authorizes that product selection, or on the pharmacist dispensing the product

selection from a physician’s oral or written order.

     (f)(g) Enforcement provisions. It is made the duty of the department of health, its agents

designated by the director of health, and of all peace officers within the state to enforce all

provisions of this section and of §§ 5-19.1-19, 5-37-18 — 5-37-18.2, and 21-31-3.

     (g)(h) Biological-product selection. The director shall permit substitution of a less-

expensive biological product, as defined in § 5-19.1-2, for a prescribed biological product only if

said less-expensive biological product is an interchangeable biological product as defined in § 5-

19.1-2. The director shall maintain on the Rhode Island state department of health website, a link

to the current list of each biological product determined by the United States Food and Drug

Administration to be an interchangeable biological product.

     (i) Device product selection. The director shall permit substitution of a less-expensive

device, or supply as defined in § 5-19.1-2, for a prescribed product only if said less-expensive

product is approved for the same indication, use, and if applicable, formulation. In the event that a

class of devices monitor differently (i.e. single reading vs continuous), the interchanged device

must monitor in the same fashion. The director shall maintain on the department of health website

a link to the current list of each product to be an interchangeable device or supply. Such examples

suitable for interchange include, but are not limited to, supplies and devices used to monitor

glucose, administer insulin or another pharmacologic product as determined by the director.

     SECTION 2. This act shall take effect on January 1, 2026.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

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     This act would amend the types of less expensive generic products which pharmacists may

prescribe to include "devices and supplies" and "therapeutically equivalent products" and would

require the director to provide a list of therapeutically equivalent products.

     This act would take effect on January 1, 2026.

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