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AN ACT
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relating to the redistribution of donated prepackaged prescription |
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drugs. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 442.001, Health and Safety Code, is |
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amended by adding Subdivision (6-a) to read as follows: |
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(6-a) "Prepackage" means the act of repackaging and |
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relabeling varying quantities of prescription drugs from a |
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manufacturer's original commercial container into a prescription |
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container, unit-dose packaging, or a multi-compartment container |
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for a pharmacist to dispense to a consumer. |
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SECTION 2. Subchapter B, Chapter 442, Health and Safety |
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Code, is amended by adding Section 442.0515 to read as follows: |
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Sec. 442.0515. REDISTRIBUTION OF DONATED PREPACKAGED |
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PRESCRIPTION DRUGS. (a) A participating provider may dispense to a |
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recipient donated prescription drugs that are prepackaged and |
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labeled in accordance with this section and rules adopted by the |
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Texas State Board of Pharmacy. |
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(b) A prepackaged prescription drug a participating |
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provider dispenses to a recipient must contain a label that |
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includes: |
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(1) the drug's brand name or, for a generic version of |
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the drug, the drug's generic name and the manufacturer or |
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distributor of the drug; |
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(2) the amount of the drug in a given dose; |
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(3) the drug's lot number; |
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(4) the earliest expiration date of the drug for that |
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drug lot number; and |
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(5) the quantity of any drug the provider dispenses in |
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more than one dose. |
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(c) A participating provider shall maintain a record of each |
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prepackaged prescription drug dispensed to a recipient. The record |
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must include: |
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(1) the drug's name, the amount of the drug in a given |
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dose, and the dosage size or frequency; |
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(2) the provider's lot number for that drug; |
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(3) the drug's manufacturer or distributor; |
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(4) the manufacturer's lot number for that drug; |
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(5) the expiration dates of the drug from that drug's |
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lot number; |
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(6) the quantity of the drug in each prepackaged unit; |
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(7) the number of prepackaged units that include the |
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drug; |
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(8) the date the drug was prepackaged; |
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(9) the name, initials, or written or electronic |
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signature of the individual who prepackaged the drug; and |
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(10) the written or electronic signature of the |
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pharmacist responsible for the drug's prepackaging. |
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SECTION 3. As soon as practicable after the effective date |
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of this Act, the Texas State Board of Pharmacy shall adopt any rules |
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necessary to implement the changes in law made by this Act. |
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SECTION 4. This Act takes effect September 1, 2023. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I certify that H.B. No. 4332 was passed by the House on April |
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28, 2023, by the following vote: Yeas 140, Nays 4, 2 present, not |
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voting. |
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______________________________ |
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Chief Clerk of the House |
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I certify that H.B. No. 4332 was passed by the Senate on May |
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17, 2023, by the following vote: Yeas 31, Nays 0. |
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______________________________ |
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Secretary of the Senate |
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APPROVED: _____________________ |
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Date |
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_____________________ |
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Governor |