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A BILL TO BE ENTITLED
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AN ACT
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relating to the dispensing of certain drugs by physicians. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 158.001, Occupations Code, is amended by |
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amending Subsection (b) and adding Subsection (d) to read as |
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follows: |
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(b) Except as provided by Subsection (d), a physician may |
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dispense dangerous drugs to the physician's patients and charge the |
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patients a reasonable fee for dispensing the drugs [This section
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does not permit a physician to operate a retail pharmacy] without |
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complying with Chapter 558. Before dispensing a dangerous drug, |
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the physician must notify the patient that the prescription for the |
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dangerous drug may be filled at a pharmacy. A physician may not |
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under this section dispense a Schedule II-V controlled substance as |
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specified under Chapter 481, Health and Safety Code. The board |
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shall adopt rules to establish a procedure for the dispensing of |
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dangerous drugs by a physician. |
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(d) Subsection (b) does not apply to workers' compensation |
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insurance coverage as defined by Section 401.011, Labor Code. |
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SECTION 2. Chapter 158, Occupations Code, is amended by |
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adding Section 158.0011 to read as follows: |
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Sec. 158.0011. DISPENSING OF DANGEROUS DRUGS FOR WORKERS' |
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COMPENSATION INSURANCE COVERAGE IN CERTAIN RURAL AREAS. (a) In |
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this section, "reimbursement for cost" means an additional charge, |
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separate from that imposed for the physician's professional |
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services, that includes the cost of the drug product and all other |
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actual costs to the physician incidental to providing the |
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dispensing service. The term does not include a separate fee |
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imposed for the act of dispensing the drug itself. |
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(b) This section applies to an area located in a county with |
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a population of 5,000 or less, or in a municipality or an |
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unincorporated town with a population of less than 2,500, that is |
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within a 15-mile radius of the physician's office and in which a |
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pharmacy is not located. This section does not apply to a |
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municipality or an unincorporated town that is adjacent to a |
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municipality with a population of 2,500 or more. |
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(c) A physician who practices medicine in an area described |
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by Subsection (b) may: |
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(1) maintain a supply of dangerous drugs in the |
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physician's office to be dispensed in the course of treating the |
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physician's patients; and |
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(2) be reimbursed for the cost of supplying those |
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drugs without obtaining a license under Chapter 558. |
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(d) A physician who dispenses dangerous drugs under |
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Subsection (c) shall: |
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(1) comply with each labeling provision under Subtitle |
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J applicable to that class of drugs; and |
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(2) oversee compliance with packaging and |
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recordkeeping provisions applicable to that class of drugs. |
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(e) A physician who desires to dispense dangerous drugs |
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under this section shall notify both the Texas State Board of |
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Pharmacy and the board that the physician practices in an area |
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described by Subsection (b). The physician may continue to |
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dispense dangerous drugs in the area until the Texas State Board of |
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Pharmacy determines, after notice and hearing, that the physician |
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no longer practices in an area described by Subsection (b). |
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SECTION 3. Subtitle B, Title 3, Occupations Code, is |
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amended by adding Chapter 158A to read as follows: |
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CHAPTER 158A. AUTHORITY OF PHYSICIAN TO PROVIDE ABORTION-INDUCING |
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DRUGS |
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Sec. 158A.001. DEFINITIONS. In this chapter: |
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(1) "Abortion" means the act of using or prescribing |
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an instrument, a medicine, a drug, or any other substance, device, |
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or means with the intent to terminate a clinically diagnosable |
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pregnancy of a woman and with knowledge that the termination by |
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those means will, with reasonable likelihood, cause the death of |
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the woman's unborn child. An act is not an abortion if the act is |
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done with the intent to: |
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(A) save the life or preserve the health of an |
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unborn child; |
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(B) remove a dead, unborn child whose death was |
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caused by spontaneous abortion; |
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(C) remove an ectopic pregnancy; or |
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(D) treat a maternal disease or illness for which |
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the prescribed drug is indicated. |
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(2) "Abortion-inducing drug" means a medicine, a drug, |
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or any other substance prescribed or dispensed with the intent of |
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terminating a clinically diagnosable pregnancy of a woman and with |
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knowledge that the termination will, with reasonable likelihood, |
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cause the death of the woman's unborn child. The term includes |
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off-label use of drugs known to have abortion-inducing properties |
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that are prescribed with the intent of causing an abortion, |
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including misoprostol and methotrexate. The term does not include |
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a drug that may be known to cause an abortion but is prescribed for |
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other medical reasons. |
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(3) "Drug label" means a pamphlet accompanying an |
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abortion-inducing drug that: |
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(A) outlines the protocol tested and authorized |
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by the United States Food and Drug Administration and agreed to by |
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the drug company applying for authorization of the drug by that |
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agency; and |
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(B) delineates how a drug is to be used according |
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to approval by that agency. |
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(4) "Gestational age" means the amount of time that |
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has elapsed since the first day of a woman's last menstrual period. |
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(5) "Medical abortion" means the use of |
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abortion-inducing drugs to induce an abortion. |
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(6) "Pregnant" means the female reproductive |
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condition of having an unborn child in a woman's uterus. |
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(7) "Unborn child" means an offspring of human beings |
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from conception until birth. |
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Sec. 158A.002. DISTRIBUTION OF ABORTION-INDUCING DRUG. (a) |
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A person may not knowingly give, sell, dispense, administer, |
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provide, or prescribe an abortion-inducing drug to a pregnant woman |
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for the purpose of inducing an abortion in the pregnant woman or |
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enabling another person to induce an abortion in the pregnant woman |
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unless: |
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(1) the person who gives, sells, dispenses, |
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administers, provides, or prescribes the abortion-inducing drug is |
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a physician; and |
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(2) the provision or prescription of the |
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abortion-inducing drug satisfies the protocol tested and |
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authorized by the United States Food and Drug Administration as |
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outlined in the abortion-inducing drug's drug label. |
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(b) Before the physician gives, sells, dispenses, |
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administers, provides, or prescribes the abortion-inducing drug, |
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the physician must examine the pregnant woman and document, in the |
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woman's medical record, the gestational age and intrauterine |
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location of the pregnancy. |
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(c) The physician who gives, sells, dispenses, administers, |
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provides, or prescribes the abortion-inducing drug shall provide |
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the pregnant woman with a copy of the abortion-inducing drug's drug |
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label. |
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(d) The physician who gives, sells, dispenses, administers, |
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provides, or prescribes the abortion-inducing drug must: |
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(1) have a signed contract with another physician who |
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agrees to treat emergencies arising from use of the drug; and |
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(2) produce the signed contract on demand by the |
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pregnant woman or the board. |
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(e) The physician who gives, sells, dispenses, administers, |
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provides, or prescribes the abortion-inducing drug shall provide |
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the pregnant woman with the name and phone number of: |
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(1) the physician who would treat an emergency arising |
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from use of the drug; and |
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(2) the hospital at which an emergency arising from |
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use of the drug would be treated. |
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(f) A physician who contracts to treat an emergency arising |
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from use of an abortion-inducing drug must have active admitting, |
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gynecological, and surgical privileges at the hospital designated |
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to treat the emergency. |
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(g) The physician who gives, sells, dispenses, administers, |
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provides, or prescribes the abortion-inducing drug or the |
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physician's agent must schedule a follow-up visit for the woman to |
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occur not more than 14 days after the administration of the drug. |
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At the follow-up visit, the physician must: |
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(1) confirm that the pregnancy is completely |
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terminated; and |
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(2) assess the degree of bleeding. |
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(h) The physician who gives, sells, dispenses, administers, |
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provides, or prescribes the abortion-inducing drug or the |
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physician's agent shall make a reasonable effort to ensure that the |
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woman returns for the scheduled appointment. The physician or the |
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physician's agent shall include a brief description of any effort |
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made to comply with this subsection, including the date, time, and |
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name of the person making the effort, in the woman's medical record. |
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(i) If a physician provides an abortion-inducing drug to a |
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pregnant woman for the purpose of inducing an abortion as |
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authorized by this section and the physician knows that the woman |
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experiences a serious adverse event, as defined by the MedWatch |
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Reporting System, during or after using the drug, the physician |
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shall report the event to the United States Food and Drug |
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Administration through the MedWatch Reporting System within three |
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days of the event. |
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Sec. 158A.003. PENALTY. A penalty may not be assessed under |
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this subtitle against a pregnant woman who receives a medical |
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abortion. |
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SECTION 4. Section 164.052(a), Occupations Code, is amended |
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to read as follows: |
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(a) A physician or an applicant for a license to practice |
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medicine commits a prohibited practice if that person: |
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(1) submits to the board a false or misleading |
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statement, document, or certificate in an application for a |
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license; |
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(2) presents to the board a license, certificate, or |
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diploma that was illegally or fraudulently obtained; |
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(3) commits fraud or deception in taking or passing an |
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examination; |
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(4) uses alcohol or drugs in an intemperate manner |
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that, in the board's opinion, could endanger a patient's life; |
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(5) commits unprofessional or dishonorable conduct |
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that is likely to deceive or defraud the public, as provided by |
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Section 164.053, or injure the public; |
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(6) uses an advertising statement that is false, |
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misleading, or deceptive; |
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(7) advertises professional superiority or the |
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performance of professional service in a superior manner if that |
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advertising is not readily subject to verification; |
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(8) purchases, sells, barters, or uses, or offers to |
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purchase, sell, barter, or use, a medical degree, license, |
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certificate, or diploma, or a transcript of a license, certificate, |
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or diploma in or incident to an application to the board for a |
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license to practice medicine; |
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(9) alters, with fraudulent intent, a medical license, |
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certificate, or diploma, or a transcript of a medical license, |
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certificate, or diploma; |
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(10) uses a medical license, certificate, or diploma, |
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or a transcript of a medical license, certificate, or diploma that |
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has been: |
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(A) fraudulently purchased or issued; |
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(B) counterfeited; or |
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(C) materially altered; |
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(11) impersonates or acts as proxy for another person |
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in an examination required by this subtitle for a medical license; |
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(12) engages in conduct that subverts or attempts to |
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subvert an examination process required by this subtitle for a |
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medical license; |
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(13) impersonates a physician or permits another to |
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use the person's license or certificate to practice medicine in |
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this state; |
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(14) directly or indirectly employs a person whose |
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license to practice medicine has been suspended, canceled, or |
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revoked; |
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(15) associates in the practice of medicine with a |
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person: |
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(A) whose license to practice medicine has been |
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suspended, canceled, or revoked; or |
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(B) who has been convicted of the unlawful |
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practice of medicine in this state or elsewhere; |
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(16) performs or procures a criminal abortion, aids or |
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abets in the procuring of a criminal abortion, attempts to perform |
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or procure a criminal abortion, or attempts to aid or abet the |
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performance or procurement of a criminal abortion; |
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(17) directly or indirectly aids or abets the practice |
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of medicine by a person, partnership, association, or corporation |
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that is not licensed to practice medicine by the board; |
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(18) performs an abortion on a woman who is pregnant |
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with a viable unborn child during the third trimester of the |
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pregnancy unless: |
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(A) the abortion is necessary to prevent the |
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death of the woman; |
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(B) the viable unborn child has a severe, |
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irreversible brain impairment; or |
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(C) the woman is diagnosed with a significant |
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likelihood of suffering imminent severe, irreversible brain damage |
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or imminent severe, irreversible paralysis; [or] |
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(19) performs an abortion on an unemancipated minor |
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without the written consent of the child's parent, managing |
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conservator, or legal guardian or without a court order, as |
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provided by Section 33.003 or 33.004, Family Code, authorizing the |
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minor to consent to the abortion, unless the physician concludes |
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that on the basis of the physician's good faith clinical judgment, a |
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condition exists that complicates the medical condition of the |
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pregnant minor and necessitates the immediate abortion of her |
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pregnancy to avert her death or to avoid a serious risk of |
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substantial impairment of a major bodily function and that there is |
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insufficient time to obtain the consent of the child's parent, |
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managing conservator, or legal guardian; or |
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(20) violates Chapter 158A. |
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SECTION 5. Section 551.004(b), Occupations Code, is amended |
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to read as follows: |
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(b) This subtitle does not prevent a practitioner from: |
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(1) administering a drug to a patient of the |
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practitioner; or |
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(2) supplying dangerous drugs to a patient as provided |
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by Section 158.001(b). |
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SECTION 6. Section 158.003, Occupations Code, is repealed. |
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SECTION 7. (a) The Texas Medical Board shall adopt rules |
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to implement Section 158.001(b), Occupations Code, as amended by |
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this Act, not later than December 1, 2011. |
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(b) The changes in law made by Sections 158.001 and 551.004, |
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Occupations Code, as amended by this Act, and Section 158.0011, |
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Occupations Code, as added by this Act, apply to the dispensing of a |
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dangerous drug by a physician on or after December 1, 2011. The |
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dispensing of a dangerous drug before December 1, 2011, is governed |
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by the law in effect immediately before the effective date of this |
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Act, and the former law is continued in effect for that purpose. |
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(c) The changes in law made by Chapter 158A, Occupations |
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Code, as added by this Act, apply only to the provision or |
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prescription of an abortion-inducing drug on or after the effective |
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date of this Act. The provision or prescription of an |
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abortion-inducing drug before the effective date of this Act is |
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governed by the law in effect at the time the drug was provided or |
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prescribed, and the former law is continued in effect for that |
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purpose. |
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SECTION 8. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect on the 91st day after the last day of the |
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legislative session. |