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HB 1801

TO AUTHORIZE AN OUTSOURCING FACILITY OF LEGEND DRUGS AND CONTROLLED SUBSTANCES THAT COMPOUNDS A PRODUCT TO SELL THE COMPOUNDED PRODUCT TO CERTAIN ENTITIES.

2025 Regular Session Introduced by Breanne Davis and 1 co-sponsor

House Bill 1801 allows outsourcing facilities to sell compounded medications to licensed pharmacies and healthcare providers, enhancing access while ensuring safety standards.

Notification that HB1801 is now Act 961
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Bill Summary · HB 1801

Summary of House Bill 1801 (Act 961)

Bill Number: HB 1801
Title: To Authorize an Outsourcing Facility of Legend Drugs and Controlled Substances that Compounds a Product to Sell the Compounded Product to Certain Entities
Status: Now Act 961
Introduced: March 17, 2025
Enacted: April 21, 2025

Purpose and Intent

House Bill 1801 aims to regulate the sale of compounded products by outsourcing facilities that handle legend drugs and controlled substances. The bill establishes a framework for these facilities to sell compounded medications to specific entities, thereby enhancing access to compounded drugs while ensuring compliance with safety standards.

Key Provisions

  1. Definition of Outsourcing Facility:

    • The bill defines an "outsourcing facility of legend drugs and controlled substances" as an entity registered as a 503B outsourcing facility with the FDA and holding a permit from the Arkansas State Board of Pharmacy.

  2. Permitted Sales:

    • The outsourcing facility may sell compounded products to:
      • Arkansas-licensed retail pharmacies for dispensing to patients.
      • Arkansas-licensed healthcare facilities for patient administration.
      • Arkansas-licensed healthcare providers (e.g., physicians, nurse practitioners) for administration in medical clinics.
    • Sales to wholesale distributors, pharmaceutical repackagers, relabelers, marketing firms, or any other entities are prohibited.

  3. Compliance with Regulations:

    • The outsourcing facility must adhere to Current Good Manufacturing Practices (CGMP) as outlined in 21 C.F.R. Parts 210, 211, and 212, effective as of January 1, 2025.

  4. Board Regulations:

    • The Arkansas State Board of Pharmacy is tasked with adopting rules regarding the dispensing of compounded products obtained from outsourcing facilities. This includes:
      • Patient education on the compounded product.
      • Disclosure of the name of the outsourcing facility.
      • Any additional requirements deemed necessary by the board.

Impact

  • Entities Affected:

    • The bill primarily impacts outsourcing facilities, Arkansas-licensed retail pharmacies, healthcare facilities, and healthcare providers involved in the dispensing and administration of compounded medications.

  • Patient Safety and Education:

    • By mandating patient education and transparency regarding the sourcing of compounded products, the bill aims to enhance patient safety and informed decision-making.

Procedural Timeline

  • March 17, 2025: Bill filed and introduced.
  • April 1, 2025: Bill received by the Senate and referred to the Public Health, Welfare and Labor Committee.
  • April 10, 2025: Bill passed by the Senate with amendments.
  • April 16, 2025: Senate amendment concurred in by the House.
  • April 21, 2025: Bill signed into law as Act 961.

This summary provides an overview of House Bill 1801, detailing its purpose, key provisions, and the implications for stakeholders in the healthcare and pharmaceutical sectors in Arkansas.

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

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