By: Harrison H.B. No. 4341
A BILL TO BE ENTITLED
AN ACT
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.