| 1 | 1 | | 84R12118 JSC-D |
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| 2 | 2 | | By: RodrÃguez S.B. No. 1790 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | A BILL TO BE ENTITLED |
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| 6 | 6 | | AN ACT |
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| 7 | 7 | | relating to the manufacture, sale, distribution, possession, and |
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| 8 | 8 | | use of drugs not approved by the United States Food and Drug |
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| 9 | 9 | | Administration and the false representation that a substance is a |
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| 10 | 10 | | drug approved by the United States Food and Drug Administration; |
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| 11 | 11 | | creating criminal offenses. |
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| 12 | 12 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 13 | 13 | | SECTION 1. Chapter 431, Health and Safety Code, is amended |
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| 14 | 14 | | by adding Subchapter E-1 to read as follows: |
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| 15 | 15 | | SUBCHAPTER E-1. DRUGS NOT APPROVED BY THE UNITED STATES FOOD AND |
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| 16 | 16 | | DRUG ADMINISTRATION |
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| 17 | 17 | | Sec. 431.121. DEFINITION. In this subchapter, "unapproved |
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| 18 | 18 | | drug" means a drug that is: |
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| 19 | 19 | | (1) unsafe for self-medication; |
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| 20 | 20 | | (2) not approved by the United States Food and Drug |
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| 21 | 21 | | Administration; and |
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| 22 | 22 | | (3) not listed in Schedules I through V or Penalty |
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| 23 | 23 | | Groups 1 through 4 of Chapter 481. |
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| 24 | 24 | | Sec. 431.122. APPLICABILITY. (a) This subchapter does not |
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| 25 | 25 | | apply to any drug, regardless of whether approved by the United |
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| 26 | 26 | | States Food and Drug Administration, that is manufactured, |
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| 27 | 27 | | packaged, distributed, or possessed for use in pharmaceutical |
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| 28 | 28 | | compounding by a licensed pharmacist, physician, or registered |
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| 29 | 29 | | outsourcing facility in compliance with federal law. |
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| 30 | 30 | | (b) This subchapter does not apply to a foreign drug not |
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| 31 | 31 | | approved by the United States Food and Drug Administration that is |
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| 32 | 32 | | imported in compliance with: |
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| 33 | 33 | | (1) federal or state law; or |
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| 34 | 34 | | (2) an announcement by the United States Food and Drug |
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| 35 | 35 | | Administration authorizing the import of the drug, including for |
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| 36 | 36 | | clinical research, drug shortages, and pandemic preparedness and |
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| 37 | 37 | | response. |
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| 38 | 38 | | (c) This subchapter does not apply to the dispensation or |
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| 39 | 39 | | sale of a drug according to a prescription issued by a practitioner. |
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| 40 | 40 | | Sec. 431.123. OFFENSE: MANUFACTURE, SALE, OR DISTRIBUTION |
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| 41 | 41 | | OF UNAPPROVED DRUG. (a) A person commits an offense if the person |
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| 42 | 42 | | manufactures, sells, or distributes an unapproved drug. |
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| 43 | 43 | | (b) An offense under this section is a state jail felony. |
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| 44 | 44 | | Sec. 431.124. OFFENSE: MISREPRESENTATION OF SUBSTANCE OR |
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| 45 | 45 | | DRUG. (a) A person commits an offense if the person falsely |
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| 46 | 46 | | represents to an individual to whom the actor or another person is |
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| 47 | 47 | | selling or distributing a substance that the substance is: |
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| 48 | 48 | | (1) a drug approved for human use by the United States |
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| 49 | 49 | | Food and Drug Administration; or |
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| 50 | 50 | | (2) intended for use in the cure, mitigation, |
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| 51 | 51 | | treatment, or prevention of disease in humans. |
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| 52 | 52 | | (b) A person commits an offense if the person falsely |
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| 53 | 53 | | represents to an individual to whom the actor or another person is |
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| 54 | 54 | | selling or distributing a drug that is approved for human use by the |
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| 55 | 55 | | United States Food and Drug Administration that the drug is: |
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| 56 | 56 | | (1) a different drug approved for human use by the |
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| 57 | 57 | | United States Food and Drug Administration; or |
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| 58 | 58 | | (2) intended for use in the cure, mitigation, |
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| 59 | 59 | | treatment, or prevention of a disease in humans when the drug is not |
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| 60 | 60 | | approved or used in clinical practice for that purpose. |
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| 61 | 61 | | (c) An offense under Subsection (a) is a state jail felony, |
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| 62 | 62 | | except that if the substance is an unapproved drug, the offense is a |
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| 63 | 63 | | felony of the third degree. |
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| 64 | 64 | | (d) An offense under Subsection (b) is a state jail felony, |
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| 65 | 65 | | except that if the drug may be dispensed only by prescription or is |
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| 66 | 66 | | not approved for use in humans, the offense is a felony of the third |
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| 67 | 67 | | degree. |
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| 68 | 68 | | Sec. 431.125. OFFENSE: POSSESSION OR USE OF UNAPPROVED |
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| 69 | 69 | | DRUG. (a) A person commits an offense if the person possesses or |
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| 70 | 70 | | uses an unapproved drug. |
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| 71 | 71 | | (b) An offense under this section is a Class A misdemeanor. |
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| 72 | 72 | | (c) It is a defense to prosecution under this section that: |
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| 73 | 73 | | (1) the actor obtained the unapproved drug from a |
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| 74 | 74 | | practitioner, pharmacist, or other person authorized to dispense |
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| 75 | 75 | | prescription drugs; and |
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| 76 | 76 | | (2) the person dispensing the unapproved drug made the |
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| 77 | 77 | | representation to the person that the drug was approved by the |
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| 78 | 78 | | United States Food and Drug Administration for prescription use. |
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| 79 | 79 | | Sec. 431.126. EFFECT ON OTHER LAWS. A person who is subject |
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| 80 | 80 | | to prosecution under this subchapter or other law may be prosecuted |
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| 81 | 81 | | under either or both laws. |
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| 82 | 82 | | SECTION 2. This Act takes effect September 1, 2015. |
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