The bill amends Section 21-31-16.1 of the Rhode Island Food, Drugs, and Cosmetics Act to expand the scope of products that pharmacists can substitute. It introduces provisions for the substitution of generic drugs, biological products, devices, supplies, and therapeutically equivalent products. The director is granted the authority to permit these substitutions, provided they comply with federal standards.

Pharmacists are required to document any substitutions made and notify the prescribing provider within seven calendar days. However, pharmacists are not mandated to make substitutions, nor are patients required to accept them. The bill clarifies that there will be no additional civil liability for the director or their agents regarding therapeutic substitutions.

Additionally, the bill includes new provisions for the substitution of medical devices, ensuring that any substituted device is approved for the same indication and use. In cases where a class of devices monitors differently (e.g., single reading vs. continuous), the interchanged device must monitor in the same fashion. Examples of suitable interchange include supplies and devices used to monitor glucose or administer insulin.

The act is set to take effect on January 1, 2026.

Statutes affected:
482: 21-31-16.1
482  SUB A: 21-31-16.1