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Signed Into Law
Signed June 20, 2025Effective 2025-09-01
SB456

Regular Session

Relating to the purchase or sale of human organs; increasing a criminal penalty.

Government Affairs & Regulatory Compliance Analysis

SB456: Government Affairs Overview

SB456 fundamentally alters the risk profile for transplant medicine in Texas by elevating the illegal purchase or sale of human organs to a State Jail Felony and mandating the revocation of a physician's license for knowingly using such organs. This legislation removes the Texas Medical Board’s discretion in disciplinary proceedings, meaning a single supply chain failure involving "knowing" use results in the permanent loss of a physician's ability to practice.

Sen. Mayes Middleton·Senate Bill·Regular Session

Critical
Low Cost
Effective:2025-09-01
Enforcing Agencies

Local District Attorneys • Texas Law Enforcement Agencies • Texas Medical Board

Business Impact

Who SB456 Affects

This legislation has regulatory implications for the following Texas businesses and organizations:

Regulatory Priority: critical

Significant regulatory changes (effective 2025-09-01). Review with your legal and compliance teams to understand implications.

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Healthcare

Affected business types:

  • Hospitals
  • Healthcare systems
  • Medical practices
  • Health insurance providers
View all healthcare legislation

Key Operational Considerations

  • 1Surgical "Time Out" Protocols: Update pre-operative checklists. The transplant team must verbally verify the organ's Chain of Custody documentation before anesthesia induction.
  • 2Procurement Staff Training: Receiving staff must be trained on a "Hard Stop" policy: if the source documentation is incomplete or ambiguous, the organ cannot be accepted into inventory.

Estimated Cost Impact

lowMinimal cost impact anticipated.

Enforcing Agencies

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SB456
Critical
Relating to the purchase or sale of human organs; increasing a criminal penalty.
Critical Compliance Urgency
Requires immediate attention
Cost Impact
Low
Effective
2025-09-01
Enforcing Agencies
Local District AttorneysTexas Law Enforcement AgenciesTexas Medical Board
Primary Author: Sen. Mayes Middleton
89th Texas Legislature
jdkey.com
01

Compliance Analysis

Key implementation requirements and action items for compliance with this legislation

Implementation Timeline

  • Effective Date: September 1, 2025
  • Compliance Deadline: September 1, 2025. All procurement protocols and vendor contracts must be updated prior to this date to ensure no non-compliant organs enter the facility on Day 1.
  • Agency Rulemaking: The Texas Medical Board (TMB) is expected to update Chapter 190 (Disciplinary Guidelines) to reflect this mandatory revocation. Watch for proposed rules between May and August 2025 regarding the evidentiary standard for "knowing" use.

Immediate Action Plan

  • 1. Audit Supply Chain: Immediately audit all current tissue and organ vendors for accreditation and compliance history.
  • 2. Revise Checklists: Insert a mandatory "Legal Source Verification" step into the surgical safety checklist for all transplant procedures.
  • 3. Update Bylaws: Amend Medical Staff Bylaws to mandate automatic suspension of privileges upon indictment for an organ trafficking offense.
  • 4. Educate Surgeons: Conduct a mandatory briefing for all transplant surgeons regarding the mandatory license revocation provision—ensure they understand their personal license is at risk.

Operational Changes Required

Contracts

  • Vendor/OPO Agreements: Immediate review required. Master Services Agreements with Organ Procurement Organizations and tissue banks must include strict representations and warranties that all tissues are obtained in compliance with Texas Penal Code 48.02. Add immediate termination rights and uncapped indemnification for regulatory/criminal defense costs.
  • Physician Employment Agreements: Amend "Termination for Cause" definitions to explicitly include "revocation of license under Occupations Code 164.0571" and "indictment for violation of Penal Code 48.02."

Hiring/Training

  • Surgical "Time Out" Protocols: Update pre-operative checklists. The transplant team must verbally verify the organ's Chain of Custody documentation before anesthesia induction.
  • Procurement Staff Training: Receiving staff must be trained on a "Hard Stop" policy: if the source documentation is incomplete or ambiguous, the organ cannot be accepted into inventory.

Reporting & Record-Keeping

  • Chain of Custody Audit Trails: Facilities must maintain a granular audit trail linking the specific patient ID to the donor source ID. This record must be retained for a minimum of 3 years (statute of limitations for State Jail Felonies), though 7 years is recommended for civil liability alignment.
  • EHR Integration: Update Electronic Health Records to require a "Source Verification" field entry before a transplant procedure code can be finalized.

Fees & Costs

  • Insurance Premiums: Expect scrutiny from malpractice carriers. Criminal acts are generally excluded from coverage; verify if your Directors & Officers (D&O) policy covers defense costs for regulatory investigations triggered by these charges.
  • Legal Defense: No new state fees, but the cost of defending a felony charge or license revocation is substantial and likely uninsurable.

Strategic Ambiguities & Considerations

  • Definition of "Knowingly": The statute requires "knowing" use for license revocation. It is unclear if the TMB will interpret "willful blindness" (failing to check paperwork) as "constructive knowledge." Until rules are published, assume the strictest standard: failure to verify documentation equals knowledge of illegality.
  • Scope of "Human Organ": While Penal Code 48.02 defines "human organ," ambiguity remains regarding processed tissue products (e.g., bone paste, particulate grafts) versus vascularized organs. We anticipate TMB rulemaking will need to clarify if minor tissue products trigger the same mandatory revocation as major organs.

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Information presented is for general knowledge only and is provided without warranty, express or implied. Consult qualified government affairs professionals and legal counsel before making compliance decisions.

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Legislative Timeline

This bill's path through the Texas Legislature

Filed
Nov 21, 2024
Passed Senate
May 6, 2025
Passed House
May 28, 2025
Signed
Jun 20, 2025
Effective
Sep 1, 2025
TopicsCrimesCrimes--against PersonsCrimes--against Persons--generalCriminal ProcedureCriminal Procedure--sentencing & PunishmentPhysiciansMedical Board, TexasOccupational RegulationOccupational Regulation--health Occupations
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Senate Authors

Sen. Mayes MiddletonRepublican · Primary Author
Coauthors (1)

House Sponsor

Rep. Janie LopezRepublican · Primary Sponsor

Bill Text(with markup)

View bill text in multiple formats on Texas Legislature website

Fiscal NoteView Original

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Quick Reference

Frequently Asked Questions

Common questions about SB456

Q

What does Texas SB456 do?

SB456 fundamentally alters the risk profile for transplant medicine in Texas by elevating the illegal purchase or sale of human organs to a State Jail Felony and mandating the revocation of a physician's license for knowingly using such organs. This legislation removes the Texas Medical Board’s discretion in disciplinary proceedings, meaning a single supply chain failure involving "knowing" use results in the permanent loss of a physician's ability to practice.

Q

Who authored SB456?

SB456 was authored by Texas Senator Mayes Middleton during the Regular Session.

Q

When was SB456 signed into law?

SB456 was signed into law by Governor Greg Abbott on June 20, 2025.

Q

Which agencies enforce SB456?

SB456 is enforced by Local District Attorneys, Texas Law Enforcement Agencies and Texas Medical Board.

Q

How significant are the changes in SB456?

The regulatory priority for SB456 is rated as "critical". Businesses and organizations should review the legislation to understand potential impacts.

Q

What is the cost impact of SB456?

The cost impact of SB456 is estimated as "low". This may vary based on industry and implementation requirements.

Q

What topics does SB456 address?

SB456 addresses topics including crimes, crimes--against persons, crimes--against persons--general, criminal procedure and criminal procedure--sentencing & punishment.

Q

What are the key dates for SB456?

Key dates for SB456: Effective date is 2025-09-01. Consult with legal counsel regarding applicability.

Q

What are the penalties under SB456?

SB456 establishes the following penalties: Criminal penalty of State Jail Felony (Confinement: 180 days to 2 years; Fine: up to $10,000) for Purchase or sale of human organs (violation of Penal Code 48.02).; Administrative penalty of Mandatory License Revocation for Physician knowingly using a human organ obtained in violation of Penal Code 48.02 in a medical procedure.. Consult with legal counsel for specific applicability to your situation.

Q

Which Texas businesses are affected by SB456?

SB456 primarily affects healthcare providers and medical facilities. These businesses should review the legislation with their legal and compliance teams to understand potential impacts.

Need Strategic Guidance on This Legislation?

JD Key Consulting is an Austin, Texas-based government affairs firm led by James Dickey, former Chairman of the Republican Party of Texas. We specialize in Texas regulatory compliance and legislative strategy for data centers, energy, banking, and manufacturing.

Legislative data provided by LegiScanLast updated: January 11, 2026