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H 385

PRESCRIPTION DRUGS – Adds to existing law to establish provisions regarding certain prohibited actions by pharmaceutical manufacturers.

68th Legislature, 1st Regular Session (2025)

Idaho H 385 bars manufacturers from blocking 340B drugs to contract pharmacies, protecting rural patients' access to discounted meds via safety-net clinics.

Reported Printed and Referred to Health & Welfare
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Bill Summary · H 385

Summary of Idaho House Bill 385 (H 385) – 2025

Overview

  • Bill Number: H 385
  • Title: PRESCRIPTION DRUGS – Adds to existing law to establish provisions regarding certain prohibited actions by pharmaceutical manufacturers.
  • Sponsor/Committee: Health and Welfare Committee
  • Status: Reported Printed and Referred to Health & Welfare; introduced March 7, 2025; emergency clause and effective date proposed.
  • Effective Date: On and after July 1, 2025 (emergency clause).
  • Fiscal Impact (per fiscal note): No anticipated state or local fiscal impact.

Purpose and Intent

The bill seeks to protect and expand access to healthcare in Idaho, with emphasis on rural areas, by safeguarding the federal 340B drug discount program. It aims to prevent pharmaceutical manufacturers from interfering with the distribution of 340B drugs to contract pharmacies and to remove barriers that could restrict safety-net clinics’ ability to distribute discounted medications. The measure envisions preserving opportunities for rural Idaho patients to obtain affordable prescription drugs through partnerships between safety-net providers and local pharmacies.

Key Provisions

Adds a new section (55-1740) to Idaho Code, defining terms and establishing prohibitions and rules related to 340B drugs:

Definitions

  • 340B drug: A covered outpatient drug that has been offered at reduced prices under the federal 340B program (42 U.S.C. 256b(a)(1)).
  • Contract pharmacy: A pharmacy licensed to receive and dispense 340B drugs on behalf of a covered entity, under contract.
  • Covered entity: An entity participating in the federal 340B program per 42 U.S.C. 256b(a)(4).
  • Pharmaceutical manufacturer: The entity or its agents/affiliates that produce drugs or biologics.
  • Pharmacy: Any location in Idaho dispensing drugs and services, including locations outside Idaho serving Idaho residents.

Prohibited Actions by Manufacturers

  1. Manufacturers shall not deny, restrict, prohibit, or interfere with the acquisition or delivery of a 340B drug to a contract pharmacy acting for a covered entity (directly or indirectly).
  2. Manufacturers shall not interfere with or restrict a contract between a covered entity and a contract pharmacy.
  3. Manufacturers shall not require a covered entity or contract pharmacy to submit, validate, certify, or provide data (claims, utilization, purchasing, etc.) as a condition for acquiring or delivering a 340B drug, with an exception for certain manufacturer audits related to specific federal compliance provisions (42 U.S.C. 256b(a)(5)(A)(i) and (B)) conducted per HHS procedures.

Compliance and Legal Structure

  • The section emphasizes alignment with federal law; states nothing that would be more restrictive than federal law or conflict with federal regulations, provided state law remains compatible.
  • A limited-distribution designation under federal law (21 U.S.C. 355-1) is not itself a violation of this section.
  • Provisions are severable; if any part is invalid, remaining provisions stay in effect.
  • If the federal 340B program is eliminated, the Idaho provisions become null and void.

Administrative and Enforcement Considerations

  • The bill notes enforcement would be carried out within existing regulatory frameworks; no new separate agency or funding is created.
  • It explicitly interfaces with the federal 340B program and requirements.

Effects and Impact

  • Who is affected: Pharmaceutical manufacturers, covered entities (e.g., safety-net clinics and similar providers), contract pharmacies, and patients in Idaho who rely on 340B-discounted medications.
  • Geographic/Access Impact: Aims to preserve and expand access to discounted medications for rural Idaho populations by removing barriers to 340B drug distribution.
  • Financial Impact: No additional state expenditures; program enforcement integrated into current regulatory processes.

Legislative Timeline

  • Introduced: March 7, 2025
  • Initial Action: Referred to Joint Rules for Award/Printing; subsequently reported Printed and Referred to Health & Welfare (as of March 10, 2025)

Notes

  • The accompanying fiscal note is a proponent statement and notes no fiscal impact, but legislative action may still influence stakeholders’ operational considerations.
  • The emergency clause seeks immediate effect upon passage, with full implementation beginning July 1, 2025.

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

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