| 1 | 1 | | 89R16149 BEE-F |
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| 2 | 2 | | By: Gervin-Hawkins H.B. No. 3785 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | |
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| 6 | 6 | | |
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| 7 | 7 | | A BILL TO BE ENTITLED |
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| 8 | 8 | | AN ACT |
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| 9 | 9 | | relating to labeling requirements for compounded drug products. |
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| 10 | 10 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 11 | 11 | | SECTION 1. Subchapter D, Chapter 562, Occupations Code, is |
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| 12 | 12 | | amended by adding Section 562.157 to read as follows: |
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| 13 | 13 | | Sec. 562.157. LABELING OF COMPOUNDED DRUG PRODUCTS. (a) |
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| 14 | 14 | | This section applies to: |
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| 15 | 15 | | (1) a pharmacy that compounds a sterile or non-sterile |
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| 16 | 16 | | preparation; and |
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| 17 | 17 | | (2) a manufacturer or other entity that compounds a |
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| 18 | 18 | | drug intended to be distributed: |
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| 19 | 19 | | (A) through a telepharmacy service; |
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| 20 | 20 | | (B) by over-the-counter sale; or |
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| 21 | 21 | | (C) directly from a pharmacist to a patient. |
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| 22 | 22 | | (b) A pharmacist may not furnish or dispense a compounded |
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| 23 | 23 | | drug to a patient unless the drug is labeled with the following |
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| 24 | 24 | | information: |
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| 25 | 25 | | (1) the patient's name; |
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| 26 | 26 | | (2) the name, address, telephone number, and license |
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| 27 | 27 | | number of: |
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| 28 | 28 | | (A) the pharmacy furnishing or dispensing the |
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| 29 | 29 | | compounded drug; or |
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| 30 | 30 | | (B) the pharmacy that prepared the compounded |
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| 31 | 31 | | drug, if that is not the same pharmacy described by Paragraph (A); |
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| 32 | 32 | | (3) the statement "Compounded Drug, Substitute for |
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| 33 | 33 | | (insert name of drug applicable to the compound)"; |
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| 34 | 34 | | (4) all active ingredients used to prepare the |
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| 35 | 35 | | compounded drug; |
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| 36 | 36 | | (5) the compounded drug's beyond-use date, as |
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| 37 | 37 | | determined by the pharmacist using appropriate documented |
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| 38 | 38 | | criteria; |
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| 39 | 39 | | (6) the quantity or amount of the compounded drug in |
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| 40 | 40 | | the container dispensed to the patient; |
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| 41 | 41 | | (7) appropriate ancillary instructions, including: |
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| 42 | 42 | | (A) storage instructions; and |
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| 43 | 43 | | (B) cautionary instructions or statements, |
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| 44 | 44 | | including any hazardous drug warning; |
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| 45 | 45 | | (8) directions for use, including all appropriate: |
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| 46 | 46 | | (A) dosage directions; and |
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| 47 | 47 | | (B) other administration directions, including |
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| 48 | 48 | | as applicable, the appropriate dosage level per time interval; |
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| 49 | 49 | | (9) any side effects noted from trials, research, and |
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| 50 | 50 | | other appropriate information sources; |
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| 51 | 51 | | (10) whether the compounded drug was prepared in a |
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| 52 | 52 | | sterile facility or a non-sterile facility; and |
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| 53 | 53 | | (11) whether the compounded drug was prepared in a |
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| 54 | 54 | | location outside of the pharmacy that furnishes the drug to the |
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| 55 | 55 | | patient. |
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| 56 | 56 | | (c) The board shall adopt rules regarding the labeling |
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| 57 | 57 | | requirements of Subsection (b) in accordance with other existing |
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| 58 | 58 | | labeling requirements. |
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| 59 | 59 | | SECTION 2. Not later than December 1, 2025, the Texas State |
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| 60 | 60 | | Board of Pharmacy shall adopt the rules required by Section |
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| 61 | 61 | | 562.157, Occupations Code, as added by this Act. |
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| 62 | 62 | | SECTION 3. This Act takes effect September 1, 2025. |
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