§ 21-31-16.1. Substitution of generic drugs and biological products. [Effective until January 1,
2026.]
(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) Appropriations. The director shall provide necessary space, personnel, and material to carry out the
provisions of this section.
(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.
(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) Pharmacists. When a pharmacist dispenses a therapeutically equivalent drug product 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) 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) 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.