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A BILL TO BE ENTITLED
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AN ACT
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relating to the administration and oversight of investigational |
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adult stem cell treatments administered to certain patients. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter B, Chapter 1003, Health and Safety |
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Code, is amended by adding Section 1003.0525 to read as follows: |
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Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The |
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department shall administer this subchapter. |
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SECTION 2. Section 1003.055(d), Health and Safety Code, is |
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amended to read as follows: |
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(d) An institutional review board that oversees |
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investigational stem cell treatments administered under this |
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subchapter must [be affiliated with]: |
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(1) be affiliated with a medical school, as defined by |
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Section 61.501, Education Code; [or] |
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(2) be affiliated with a hospital licensed under |
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Chapter 241 that has at least 150 beds; |
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(3) be accredited by the Association for the |
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Accreditation of Human Research Protection Programs; |
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(4) be registered by the United States Department of |
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Health and Human Services, Office for Human Research Protections, |
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in accordance with 21 C.F.R. Part 56; or |
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(5) be accredited by a national accreditation |
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organization acceptable to the department. |
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SECTION 3. Section 1003.058(b), Health and Safety Code, is |
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amended to read as follows: |
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(b) A governmental entity or an officer, employee, or agent |
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of a governmental entity may not interfere with an eligible |
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patient's access to or use of a stem cell treatment authorized under |
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this subchapter unless the treatment uses a drug that is considered |
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adulterated or misbranded under Chapter 431. For purposes of this |
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subsection, a governmental entity may not consider the drug to be |
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adulterated or misbranded solely on the basis that the United |
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States Food and Drug Administration has not approved the drug. |
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SECTION 4. Subchapter B, Chapter 1003, Health and Safety |
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Code, is amended by adding Section 1003.060 to read as follows: |
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Sec. 1003.060. CONSTRUCTION OF SUBCHAPTER. This subchapter |
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may not be construed to: |
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(1) prohibit a physician from using adult stem cells |
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for their intended homologous use if the stem cells are: |
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(A) registered by the United States Food and Drug |
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Administration; and |
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(B) commercially available; or |
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(2) require an institutional review board to oversee |
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treatment using adult stem cells registered by the United States |
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Food and Drug Administration for their intended homologous use. |
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SECTION 5. This Act takes effect September 1, 2019. |