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HB 2346

Commercial code; Commercial Code Reform Act of 2025; effective date.

2025 Regular Session Introduced by Kyle Hilbert

IDPH will oversee the Illinois Drug Reuse Program, publish pharmacy participation lists, require data reporting, educate participants, and issue annual public reports starting 2026.

Second Reading referred to Rules
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Bill Summary · HB 2346

Note: the materials you provided for “HB 2346” contain conflicting titles and multiple state versions. The official enrolled/engrossed text and legislative actions included in the packet show Illinois HB 2346, which amends the Illinois Drug Reuse Opportunity Program Act and was enacted as Public Act 104‑0212 (effective January 1, 2026). The summary below covers that Illinois enactment.

Summary — HB 2346 (Illinois) / Public Act 104‑0212

Purpose
- Amend the Illinois Drug Reuse Opportunity Program Act to clarify definitions and recordkeeping/retention rules and to require the Illinois Department of Public Health (IDPH) to provide program support, education, and public reporting about pharmacies participating in the drug‑reuse program.

Key provisions and changes
- Definitions (410 ILCS 715/5)
- Clarifies or restates key terms used in the Act, including: “controlled substance” (defined by 21 CFR 1308, Schedules I–V); “department” (IDPH); “donor”; “drug” (prescription, OTC, and administration supplies); “eligible patient”; “manufacturer”; “pharmacist”; “practitioner”; “recipient”; “returns processor” (per 21 U.S.C. 360eee); “unopened tamper‑evident packaging”; and “priority patient.”
- Specifically excludes certain cancer drugs (requiring manufacturer registration) from the definition of “prescription drug.”

  • Recordkeeping (410 ILCS 715/45)

    • Recipients processing donated drugs for tax, manufacturer, or other credit are treated as “returns processors” and must comply with federal recordkeeping requirements for nonsalable/nonsaleable returns.
    • Records maintained under the Act are subject to IDPH access upon request.

  • Retention of records (410 ILCS 715/55)

    • All required records must be retained (physically or electronically, on or off site) for 6 years.
    • Donors/recipients may contract third parties to create/maintain records on their behalf.
    • Use of identifiers (e.g., serial numbers/bar codes) is permitted in place of full information if original data are readily retrievable; identifiers must be replaced with original information upon request by state/federal regulatory agencies.
    • Identifiers shall not be used on patient labels when dispensing/administrating drugs.

  • New Section — Program support by IDPH (410 ILCS 715/70 new)

    • IDPH duties:
    • Maintain and publish (on its website) names/locations of pharmacies participating in the Illinois Drug Reuse Opportunity Program.
    • Educate pharmacies about the program and voluntary participation procedures.
    • Develop/publish public educational materials about the program’s purpose and benefits.
    • Collect data from program participants and publish an annual report to the General Assembly by December 31 each year, beginning December 31, 2026.
    • Pharmacy recipients must notify IDPH of their participation and report required data in a reasonable format set by the Department.

Who is affected
- Pharmacies that participate as recipients and dispensers in the Drug Reuse Opportunity Program.
- Donors of unused/unopened medication (includes wholesalers, distributors, pharmacies, clinics, hospitals, long‑term care facilities, certain federal facilities, etc.).
- Manufacturers, reverse distributors/returns processors, and other entities handling donated drugs.
- Eligible and priority patients who may receive dispensed reused drugs.
- IDPH, which assumes expanded outreach, education, data collection and reporting responsibilities.

Procedural / timeline notes
- Enacted as Public Act 104‑0212; Governor approved August 15, 2025.
- Effective date: January 1, 2026.
- Annual IDPH reporting requirement begins December 31, 2026.
- Record retention requirement: 6 years.

Potential impacts
- Increases IDPH operational responsibilities (website listings, education, data collection/reporting).
- Establishes clearer federal compliance expectation for recipients acting as returns processors (potential changes to recipient record systems and policies).
- Requires participating pharmacies to register with and report data to IDPH—administrative burden but improves oversight and transparency.
- Helps public visibility of participating pharmacies and supports program outreach to increase patient access to unused, safe medications.

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

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