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A BILL TO BE ENTITLED
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AN ACT
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relating to the manufacture, sale, distribution, possession, and |
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use of drugs not approved by the United States Food and Drug |
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Administration and the false representation that a substance is a |
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drug approved by the United States Food and Drug Administration; |
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creating criminal offenses. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 431, Health and Safety Code, is amended |
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by adding Subchapter E-1 to read as follows: |
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SUBCHAPTER E-1. DRUGS NOT APPROVED BY THE UNITED STATES FOOD AND |
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DRUG ADMINISTRATION |
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Sec. 431.121. DEFINITION. In this subchapter, "unapproved |
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drug" means a drug that is: |
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(1) unsafe for self-medication; |
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(2) not approved by the United States Food and Drug |
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Administration; and |
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(3) not listed in Schedules I through V or Penalty |
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Groups 1 through 4 of Chapter 481. |
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Sec. 431.122. APPLICABILITY. (a) This subchapter does not |
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apply to any drug, regardless of whether approved by the United |
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States Food and Drug Administration, that is manufactured, |
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packaged, distributed, or possessed for use in pharmaceutical |
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compounding by a licensed pharmacist, physician, or registered |
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outsourcing facility in compliance with federal law. |
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(b) This subchapter does not apply to a foreign drug not |
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approved by the United States Food and Drug Administration that is |
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imported in compliance with: |
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(1) federal or state law; or |
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(2) an announcement by the United States Food and Drug |
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Administration authorizing the import of the drug, including for |
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clinical research, drug shortages, and pandemic preparedness and |
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response. |
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(c) This subchapter does not apply to the dispensation or |
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sale of a drug according to a prescription issued by a practitioner. |
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Sec. 431.123. OFFENSE: MANUFACTURE, SALE, OR DISTRIBUTION |
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OF UNAPPROVED DRUG. (a) A person commits an offense if the person |
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manufactures, sells, or distributes an unapproved drug. |
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(b) An offense under this section is a state jail felony. |
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Sec. 431.124. OFFENSE: MISREPRESENTATION OF SUBSTANCE OR |
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DRUG. (a) A person commits an offense if the person falsely |
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represents to an individual to whom the actor or another person is |
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selling or distributing a substance that the substance is: |
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(1) a drug approved for human use by the United States |
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Food and Drug Administration; or |
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(2) intended for use in the cure, mitigation, |
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treatment, or prevention of disease in humans. |
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(b) A person commits an offense if the person falsely |
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represents to an individual to whom the actor or another person is |
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selling or distributing a drug that is approved for human use by the |
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United States Food and Drug Administration that the drug is: |
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(1) a different drug approved for human use by the |
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United States Food and Drug Administration; or |
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(2) intended for use in the cure, mitigation, |
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treatment, or prevention of a disease in humans when the drug is not |
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approved or used in clinical practice for that purpose. |
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(c) An offense under Subsection (a) is a state jail felony, |
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except that if the substance is an unapproved drug, the offense is a |
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felony of the third degree. |
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(d) An offense under Subsection (b) is a state jail felony, |
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except that if the drug may be dispensed only by prescription or is |
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not approved for use in humans, the offense is a felony of the third |
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degree. |
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Sec. 431.125. OFFENSE: POSSESSION OR USE OF UNAPPROVED |
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DRUG. (a) A person commits an offense if the person possesses or |
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uses an unapproved drug. |
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(b) An offense under this section is a Class A misdemeanor. |
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(c) It is a defense to prosecution under this section that: |
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(1) the actor obtained the unapproved drug from a |
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practitioner, pharmacist, or other person authorized to dispense |
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prescription drugs; and |
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(2) the person dispensing the unapproved drug made the |
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representation to the person that the drug was approved by the |
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United States Food and Drug Administration for prescription use. |
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Sec. 431.126. EFFECT ON OTHER LAWS. A person who is subject |
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to prosecution under this subchapter or other law may be prosecuted |
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under either or both laws. |
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SECTION 2. This Act takes effect September 1, 2015. |