| 1 | 1 | | H.B. No. 4332 |
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| 2 | 2 | | |
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| 3 | 3 | | |
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| 4 | 4 | | AN ACT |
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| 5 | 5 | | relating to the redistribution of donated prepackaged prescription |
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| 6 | 6 | | drugs. |
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| 7 | 7 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 8 | 8 | | SECTION 1. Section 442.001, Health and Safety Code, is |
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| 9 | 9 | | amended by adding Subdivision (6-a) to read as follows: |
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| 10 | 10 | | (6-a) "Prepackage" means the act of repackaging and |
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| 11 | 11 | | relabeling varying quantities of prescription drugs from a |
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| 12 | 12 | | manufacturer's original commercial container into a prescription |
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| 13 | 13 | | container, unit-dose packaging, or a multi-compartment container |
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| 14 | 14 | | for a pharmacist to dispense to a consumer. |
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| 15 | 15 | | SECTION 2. Subchapter B, Chapter 442, Health and Safety |
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| 16 | 16 | | Code, is amended by adding Section 442.0515 to read as follows: |
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| 17 | 17 | | Sec. 442.0515. REDISTRIBUTION OF DONATED PREPACKAGED |
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| 18 | 18 | | PRESCRIPTION DRUGS. (a) A participating provider may dispense to a |
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| 19 | 19 | | recipient donated prescription drugs that are prepackaged and |
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| 20 | 20 | | labeled in accordance with this section and rules adopted by the |
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| 21 | 21 | | Texas State Board of Pharmacy. |
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| 22 | 22 | | (b) A prepackaged prescription drug a participating |
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| 23 | 23 | | provider dispenses to a recipient must contain a label that |
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| 24 | 24 | | includes: |
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| 25 | 25 | | (1) the drug's brand name or, for a generic version of |
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| 26 | 26 | | the drug, the drug's generic name and the manufacturer or |
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| 27 | 27 | | distributor of the drug; |
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| 28 | 28 | | (2) the amount of the drug in a given dose; |
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| 29 | 29 | | (3) the drug's lot number; |
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| 30 | 30 | | (4) the earliest expiration date of the drug for that |
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| 31 | 31 | | drug lot number; and |
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| 32 | 32 | | (5) the quantity of any drug the provider dispenses in |
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| 33 | 33 | | more than one dose. |
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| 34 | 34 | | (c) A participating provider shall maintain a record of each |
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| 35 | 35 | | prepackaged prescription drug dispensed to a recipient. The record |
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| 36 | 36 | | must include: |
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| 37 | 37 | | (1) the drug's name, the amount of the drug in a given |
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| 38 | 38 | | dose, and the dosage size or frequency; |
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| 39 | 39 | | (2) the provider's lot number for that drug; |
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| 40 | 40 | | (3) the drug's manufacturer or distributor; |
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| 41 | 41 | | (4) the manufacturer's lot number for that drug; |
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| 42 | 42 | | (5) the expiration dates of the drug from that drug's |
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| 43 | 43 | | lot number; |
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| 44 | 44 | | (6) the quantity of the drug in each prepackaged unit; |
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| 45 | 45 | | (7) the number of prepackaged units that include the |
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| 46 | 46 | | drug; |
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| 47 | 47 | | (8) the date the drug was prepackaged; |
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| 48 | 48 | | (9) the name, initials, or written or electronic |
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| 49 | 49 | | signature of the individual who prepackaged the drug; and |
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| 50 | 50 | | (10) the written or electronic signature of the |
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| 51 | 51 | | pharmacist responsible for the drug's prepackaging. |
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| 52 | 52 | | SECTION 3. As soon as practicable after the effective date |
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| 53 | 53 | | of this Act, the Texas State Board of Pharmacy shall adopt any rules |
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| 54 | 54 | | necessary to implement the changes in law made by this Act. |
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| 55 | 55 | | SECTION 4. This Act takes effect September 1, 2023. |
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| 56 | 56 | | ______________________________ ______________________________ |
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| 57 | 57 | | President of the Senate Speaker of the House |
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| 58 | 58 | | I certify that H.B. No. 4332 was passed by the House on April |
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| 59 | 59 | | 28, 2023, by the following vote: Yeas 140, Nays 4, 2 present, not |
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| 60 | 60 | | voting. |
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| 61 | 61 | | ______________________________ |
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| 62 | 62 | | Chief Clerk of the House |
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| 63 | 63 | | I certify that H.B. No. 4332 was passed by the Senate on May |
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| 64 | 64 | | 17, 2023, by the following vote: Yeas 31, Nays 0. |
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| 65 | 65 | | ______________________________ |
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| 66 | 66 | | Secretary of the Senate |
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| 67 | 67 | | APPROVED: _____________________ |
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| 68 | 68 | | Date |
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| 69 | 69 | | _____________________ |
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| 70 | 70 | | Governor |
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