Bill Text: TX HB4341 | 2023-2024 | 88th Legislature | Introduced
Bill Title: Relating to promoting, prescribing, administering, or dispensing prescription drugs for off-label use.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2023-03-21 - Referred to Public Health [HB4341 Detail]
Download: Texas-2023-HB4341-Introduced.html
By: Harrison | H.B. No. 4341 |
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relating to promoting, prescribing, administering, or dispensing | ||
prescription drugs for off-label use. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subtitle A, Title 6, Health and Safety Code, is | ||
amended by adding Chapter 444 to read as follows: | ||
CHAPTER 444. OFF-LABEL USE OF PRESCRIPTION DRUGS | ||
Sec. 444.001. DEFINITIONS. In this chapter: | ||
(1) "Off-label use" means the use of a prescription | ||
drug approved for use by the United States Food and Drug | ||
Administration in a manner other than the approved use. | ||
(2) "Pharmacist" means a person licensed by the Texas | ||
State Board of Pharmacy to practice pharmacy. | ||
(3) "Physician" means an individual licensed by the | ||
Texas Medical Board to practice medicine in this state. | ||
Sec. 444.002. APPLICABILITY. This chapter applies only to | ||
the promoting, prescribing, administering, and dispensing of a | ||
prescription drug the United States Food and Drug Administration | ||
has approved for human use. | ||
Sec. 444.003. PROHIBITED DISCIPLINARY ACTION AGAINST | ||
PHYSICIAN'S OR PHARMACIST'S LICENSE. The state agency with | ||
licensing or regulatory authority over a physician or pharmacist | ||
may not revoke, fail to renew, suspend, or take any other adverse | ||
action against a physician's or pharmacist's license based solely | ||
on the physician or pharmacist: | ||
(1) prescribing, administering, or dispensing a | ||
prescription drug for off-label use to treat a patient, unless such | ||
authorities prove beyond a reasonable doubt that the prescribing, | ||
administering, or dispensing led to the direct physical harm of a | ||
person who was a patient within the 3 years immediately preceding | ||
the physical harm; or | ||
(2) communicating or otherwise promoting to a patient | ||
an off-label use of a prescription drug, unless such authorities | ||
prove beyond a reasonable doubt that the speech led to the direct | ||
physical harm of a person who was a patient within the 3 years | ||
immediately preceding the physical harm. | ||
SECTION 2. The changes in law made by this Act apply only to | ||
a prescription issued or a prescription drug promoted, | ||
administered, or dispensed on or after the effective date of this | ||
Act. | ||
SECTION 3. This Act takes effect September 1, 2023. |