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HB 5855

AN ACT RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND COSMETICS ACT

2025 Regular Session Introduced by Jennifer Boylan and 9 co-sponsors

Rhode Island pharmacies can substitute lower-cost therapeutically equivalent drugs, certain devices, supplies, and interchangeable biologics when appropriate, with documentation an

06/24/2025 Signed by Governor
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Bill Summary · HB 5855

Summary — HB 5855 (Sub A) — Rhode Island Food, Drugs, and Cosmetics Act

Status: Signed by Governor (June 24, 2025). Effective date: January 1, 2026.
Introduced: February 28, 2025. Referred to House Health & Human Services.

Main purpose

HB 5855 Sub A expands and clarifies the authority of pharmacists in Rhode Island to make substitutions for prescribed products. It explicitly allows pharmacists to perform therapeutic interchange of drugs and to substitute certain devices, supplies, and interchangeable biological products when those substitutes are considered therapeutically equivalent or appropriate.

Key provisions

  • Scope of substitution (amends § 21-31-16.1):
    • Permits substitution of less-expensive therapeutically equivalent drugs and pharmaceuticals (excluding, except as otherwise noted, biological products) as determined by the state director of health, consistent with FDA standards (§§ 505 and 507).
    • Adds explicit authority to substitute devices and supplies (e.g., glucose monitoring supplies, insulin delivery devices) provided the substitute is approved for the same indication/use and, where applicable, monitors in the same fashion (e.g., single reading vs continuous).
    • Permits substitution of biological products only if the substitute is an FDA-designated “interchangeable biological product.” The Department of Health must provide and maintain a link on its website to the current FDA list of interchangeable biologics.
  • Documentation and notice:
    • Pharmacists who substitute therapeutically equivalent products must document the change on the prescription.
    • Pharmacists must notify the prescribing provider of the substitution within seven (7) calendar days.
  • Voluntary substitution:
    • Pharmacists are not required to make substitutions and patients are not required to accept substitutions.
    • Therapeutic interchange may be used for initial prescriptions (“first fills”) and ongoing therapy.
  • Liability and enforcement:
    • No civil liability arises for the director or designated agents for listing or omitting products from the state’s substitution lists.
    • Substituting products does not create additional civil liability for the prescribing clinician or the pharmacist performing the substitution.
    • Enforcement authority is assigned to the Rhode Island Department of Health, its agents, and peace officers as appropriate.
  • Reporting and administration:
    • The director must publish lists (and revisions) of products deemed therapeutically equivalent and produce an annual report to the General Assembly (by February 10) that includes approved interchangeable products and an estimate of average public savings.
  • Effective date: January 1, 2026.

Who is affected

  • Pharmacists and pharmacies: new authority and responsibilities (documentation and prescriber notification).
  • Prescribers: may receive substitution notifications; protected from additional liability when substitutions occur under the law.
  • Patients: increased potential access to lower-cost therapeutically equivalent drugs, devices, supplies, and interchangeable biologics; not required to accept substitutions.
  • Department of Health: must maintain substitution lists, website link for interchangeable biologics, and produce annual reports.
  • Payers and suppliers: potential changes in dispensed products and cost-savings implications.

Implementation & timeline

  • Law takes effect January 1, 2026, giving the Department of Health time to prepare lists, website links, and reporting processes.
  • Pharmacists must begin complying with the documentation and 7‑day prescriber notification requirement as of the effective date.

Legislative history (selected)

  • Introduced (House): February 28, 2025.
  • Committee actions: hearings, proposed substitute, committee recommended passage of Sub A (June 3, 2025).
  • House passed Sub A: June 12, 2025.
  • Senate concurrence with Sub A and transmitted to Governor: June 18, 2025.
  • Signed by Governor: June 24, 2025.

Potential impacts and considerations

  • Expected to increase dispensing flexibility and reduce prescription costs by enabling substitution to lower-cost therapeutically equivalent products.
  • Requires operational changes in pharmacies (documentation, notification workflows).
  • Patient and clinician education will be important to ensure understanding of substitution rights and protections.
  • Safety and clinical appropriateness are addressed by limiting biologic substitutions to FDA-designated interchangeable products and by requiring device/supply substitutions to match indications and monitoring modalities.

Compiled from official sources — confirm details with the bill’s official record.

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