| 1 | 1 | | By: Harrison H.B. No. 4341 |
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| 2 | 2 | | |
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| 3 | 3 | | |
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| 4 | 4 | | A BILL TO BE ENTITLED |
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| 5 | 5 | | AN ACT |
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| 6 | 6 | | relating to promoting, prescribing, administering, or dispensing |
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| 7 | 7 | | prescription drugs for off-label use. |
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| 8 | 8 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 9 | 9 | | SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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| 10 | 10 | | amended by adding Chapter 444 to read as follows: |
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| 11 | 11 | | CHAPTER 444. OFF-LABEL USE OF PRESCRIPTION DRUGS |
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| 12 | 12 | | Sec. 444.001. DEFINITIONS. In this chapter: |
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| 13 | 13 | | (1) "Off-label use" means the use of a prescription |
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| 14 | 14 | | drug approved for use by the United States Food and Drug |
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| 15 | 15 | | Administration in a manner other than the approved use. |
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| 16 | 16 | | (2) "Pharmacist" means a person licensed by the Texas |
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| 17 | 17 | | State Board of Pharmacy to practice pharmacy. |
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| 18 | 18 | | (3) "Physician" means an individual licensed by the |
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| 19 | 19 | | Texas Medical Board to practice medicine in this state. |
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| 20 | 20 | | Sec. 444.002. APPLICABILITY. This chapter applies only to |
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| 21 | 21 | | the promoting, prescribing, administering, and dispensing of a |
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| 22 | 22 | | prescription drug the United States Food and Drug Administration |
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| 23 | 23 | | has approved for human use. |
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| 24 | 24 | | Sec. 444.003. PROHIBITED DISCIPLINARY ACTION AGAINST |
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| 25 | 25 | | PHYSICIAN'S OR PHARMACIST'S LICENSE. The state agency with |
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| 26 | 26 | | licensing or regulatory authority over a physician or pharmacist |
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| 27 | 27 | | may not revoke, fail to renew, suspend, or take any other adverse |
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| 28 | 28 | | action against a physician's or pharmacist's license based solely |
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| 29 | 29 | | on the physician or pharmacist: |
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| 30 | 30 | | (1) prescribing, administering, or dispensing a |
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| 31 | 31 | | prescription drug for off-label use to treat a patient, unless such |
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| 32 | 32 | | authorities prove beyond a reasonable doubt that the prescribing, |
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| 33 | 33 | | administering, or dispensing led to the direct physical harm of a |
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| 34 | 34 | | person who was a patient within the 3 years immediately preceding |
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| 35 | 35 | | the physical harm; or |
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| 36 | 36 | | (2) communicating or otherwise promoting to a patient |
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| 37 | 37 | | an off-label use of a prescription drug, unless such authorities |
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| 38 | 38 | | prove beyond a reasonable doubt that the speech led to the direct |
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| 39 | 39 | | physical harm of a person who was a patient within the 3 years |
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| 40 | 40 | | immediately preceding the physical harm. |
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| 41 | 41 | | SECTION 2. The changes in law made by this Act apply only to |
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| 42 | 42 | | a prescription issued or a prescription drug promoted, |
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| 43 | 43 | | administered, or dispensed on or after the effective date of this |
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| 44 | 44 | | Act. |
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| 45 | 45 | | SECTION 3. This Act takes effect September 1, 2023. |
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