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A BILL TO BE ENTITLED
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AN ACT
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relating to labeling requirements for compounded drug products. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter D, Chapter 562, Occupations Code, is |
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amended by adding Section 562.157 to read as follows: |
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Sec. 562.157. LABELING OF COMPOUNDED DRUG PRODUCTS. (a) |
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This section applies to: |
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(1) a pharmacy that compounds a sterile or non-sterile |
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preparation; and |
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(2) a manufacturer or other entity that compounds a |
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drug intended to be distributed: |
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(A) through a telepharmacy service; |
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(B) by over-the-counter sale; or |
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(C) directly from a pharmacist to a patient. |
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(b) A pharmacist may not furnish or dispense a compounded |
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drug to a patient unless the drug is labeled with the following |
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information: |
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(1) the patient's name; |
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(2) the name, address, telephone number, and license |
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number of: |
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(A) the pharmacy furnishing or dispensing the |
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compounded drug; or |
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(B) the pharmacy that prepared the compounded |
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drug, if that is not the same pharmacy described by Paragraph (A); |
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(3) the statement "Compounded Drug, Substitute for |
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(insert name of drug applicable to the compound)"; |
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(4) all active ingredients used to prepare the |
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compounded drug; |
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(5) the compounded drug's beyond-use date, as |
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determined by the pharmacist using appropriate documented |
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criteria; |
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(6) the quantity or amount of the compounded drug in |
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the container dispensed to the patient; |
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(7) appropriate ancillary instructions, including: |
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(A) storage instructions; and |
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(B) cautionary instructions or statements, |
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including any hazardous drug warning; |
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(8) directions for use, including all appropriate: |
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(A) dosage directions; and |
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(B) other administration directions, including |
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as applicable, the appropriate dosage level per time interval; |
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(9) any side effects noted from trials, research, and |
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other appropriate information sources; |
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(10) whether the compounded drug was prepared in a |
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sterile facility or a non-sterile facility; and |
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(11) whether the compounded drug was prepared in a |
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location outside of the pharmacy that furnishes the drug to the |
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patient. |
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(c) The board shall adopt rules regarding the labeling |
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requirements of Subsection (b) in accordance with other existing |
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labeling requirements. |
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SECTION 2. Not later than December 1, 2025, the Texas State |
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Board of Pharmacy shall adopt the rules required by Section |
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562.157, Occupations Code, as added by this Act. |
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SECTION 3. This Act takes effect September 1, 2025. |