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A BILL TO BE ENTITLED
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AN ACT
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relating to promoting, prescribing, administering, or dispensing |
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prescription drugs for off-label use. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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amended by adding Chapter 446 to read as follows: |
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CHAPTER 446. OFF-LABEL USE OF PRESCRIPTION DRUGS |
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Sec. 446.001. DEFINITIONS. In this chapter: |
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(1) "Off-label use" means the use of a prescription |
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drug approved for use by the United States Food and Drug |
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Administration in a manner other than the approved use. |
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(2) "Pharmacist" means a person licensed by the Texas |
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State Board of Pharmacy to practice pharmacy. |
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(3) "Physician" means an individual licensed by the |
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Texas Medical Board to practice medicine in this state. |
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Sec. 446.002. APPLICABILITY. This chapter applies only to |
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the promoting, prescribing, administering, and dispensing of a |
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prescription drug the United States Food and Drug Administration |
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has approved for human use. |
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Sec. 446.003. PROHIBITED DISCIPLINARY ACTION AGAINST |
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PHYSICIAN'S OR PHARMACIST'S LICENSE. (a) Except as provided by |
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Subsection (b), the state agency with licensing or regulatory |
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authority over a physician or pharmacist may not revoke, fail to |
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renew, suspend, or take any other adverse action against a |
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physician's or pharmacist's license based solely on the physician |
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or pharmacist: |
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(1) prescribing, administering, or dispensing a |
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prescription drug for off-label use to treat a patient; or |
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(2) communicating or otherwise promoting to a patient |
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an off-label use of a prescription drug. |
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(b) The state agency with licensing or regulatory authority |
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over a physician or pharmacist may revoke, fail to renew, suspend, |
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or take any other adverse action against a physician's or |
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pharmacist's license based on conduct described by Subsection |
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(a)(1) or (2) if, after notice and hearing, the agency proves beyond |
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a reasonable doubt that: |
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(1) the conduct caused the physician's or pharmacist's |
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patient to suffer physical harm; and |
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(2) the initial onset of the patient's physical harm |
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occurred not later than three years after the date of the |
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physician's or pharmacist's conduct. |
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SECTION 2. The changes in law made by this Act apply only to |
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a prescription issued or a prescription drug promoted, |
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administered, or dispensed on or after the effective date of this |
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Act. |
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SECTION 3. This Act takes effect September 1, 2025. |