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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 444 to read as follows: |
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CHAPTER 444. OFF-LABEL USE OF PRESCRIPTION DRUGS |
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Sec. 444.001. 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. 444.002. 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. 444.003. PROHIBITED DISCIPLINARY ACTION AGAINST |
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PHYSICIAN'S OR PHARMACIST'S LICENSE. The state agency with |
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licensing or regulatory authority over a physician or pharmacist |
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may not revoke, fail to renew, suspend, or take any other adverse |
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action against a physician's or pharmacist's license based solely |
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on the physician 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, unless such |
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authorities prove beyond a reasonable doubt that the prescribing, |
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administering, or dispensing led to the direct physical harm of a |
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person who was a patient within the 3 years immediately preceding |
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the physical harm; 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, unless such authorities |
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prove beyond a reasonable doubt that the speech led to the direct |
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physical harm of a person who was a patient within the 3 years |
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immediately preceding the physical harm. |
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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, 2023. |