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A BILL TO BE ENTITLED
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AN ACT
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relating to required reports of certain vaccine-related or |
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drug-related injuries and adverse events. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 161, Health and Safety |
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Code, is amended by adding Section 161.0103 to read as follows: |
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Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED |
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INJURIES AND ADVERSE EVENTS. (a) This section applies only to a |
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vaccine that is: |
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(1) experimental or investigational; or |
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(2) approved or authorized for emergency use by the |
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United States Food and Drug Administration. |
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(b) Notwithstanding any other law, for a vaccine to which |
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this section applies a physician shall report to the federal |
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Vaccine Adverse Event Reporting System: |
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(1) each potential vaccine-related injury of a patient |
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the physician treats; and |
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(2) any adverse event following the patient's |
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vaccination. |
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(c) A physician who violates this section is subject to |
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disciplinary action by the Texas Medical Board as if the physician |
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violated Subtitle B, Title 3, Occupations Code. |
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(d) The executive commissioner shall adopt rules necessary |
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to implement this section. |
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SECTION 2. Subchapter E, Chapter 431, Health and Safety |
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Code, is amended by adding Section 431.1145 to read as follows: |
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Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED |
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INJURIES AND ADVERSE EVENTS. (a) This section applies only to a |
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drug that is: |
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(1) experimental or investigational; or |
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(2) approved or authorized for emergency use by the |
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United States Food and Drug Administration. |
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(b) Notwithstanding any other law, for a drug to which this |
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section applies a physician shall report to the United States Food |
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and Drug Administration through the MedWatch Reporting System: |
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(1) each potential drug-related injury of a patient |
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the physician treats; and |
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(2) any adverse event following the administration or |
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use of the drug. |
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(c) A physician who violates this section is subject to |
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disciplinary action by the Texas Medical Board as if the physician |
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violated Subtitle B, Title 3, Occupations Code. |
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(d) The executive commissioner shall adopt rules necessary |
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to implement this section. |
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SECTION 3. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt rules necessary to implement the |
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changes in law made by this Act. |
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SECTION 4. This Act takes effect September 1, 2023. |