Rhode Island General Laws Title 21. Food and Drugs § 21-31-16.1. 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 drugs and pharmaceuticals, excluding biological products, considered as therapeutically equivalent and interchangeable with specific 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 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.

(b)  Drug products deemed to be therapeutically equivalent are outside of brand/generic switches or biological interchangeable products.

(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 therapeutic substitution.

(d) Pharmacists.  When a pharmacist dispenses a therapeutically equivalent drug or pharmaceutical or interchangeable biological product, there shall be no additional liability imposed on the prescriber or on the pharmacist performing therapeutic substitution or dispensing the product selection from a physician's oral or written order.

(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.

(f) Biological-product selection.  The director shall permit substitution of an equivalent biological product, as defined in § 5-19.1-2, for another prescribed biological product only if said biological product is interchangeable as defined in § 5-19.1-2.

(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.