| Chapter 146 |
| 2025 -- H 5855 SUBSTITUTE A Enacted 06/24/2025 |
| 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 |
| 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 may 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) Appropriations. The director shall provide necessary space, personnel, and material to |
| carry out the provisions of this section. |
| Drug products deemed to be therapeutically equivalent are outside of brand/generic |
| switches or biological interchangeable products. |
| (1) Pharmacists substituting therapeutically equivalent products shall document the change |
| on the prescription and notify the prescribing provider of the change within seven (7) calendar days. |
| (2) Pharmacists shall not be mandated to substitute therapeutically equivalent products nor |
| are patients required to accept a medication substitution. |
| (3) Therapeutic interchange applies to initial starts or “first fills” as well as those continuing |
| care. |
| (c) 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 therapeutic |
| substitution. |
| (d) 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)(d) Pharmacists. When a pharmacist dispenses a therapeutically equivalent drug product |
| or pharmaceutical or interchangeable biological product, there shall be no additional liability |
| imposed on the prescriber who authorizes that product selection, or on the pharmacist performing |
| therapeutic substitution or dispensing the product selection from a physician’s oral or written order. |
| (f)(e) 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)(f) Biological-product selection. The director shall permit substitution of a less- |
| expensive an equivalent biological product, as defined in § 5-19.1-2, for a another 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. |
| (g) Device product selection. The director shall permit substitution of a device, or supply |
| as defined in § 5-19.1-2, for a prescribed product only if said 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. Such examples suitable for interchange include, but are not limited to, supplies and devices |
| used to monitor glucose, administer insulin or another pharmacologic product. |
| SECTION 2. This act shall take effect on January 1, 2026. |
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| LC001847/SUB A |
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