89R1261 JG-F
By: Harrison H.B. No. 855
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 446 to read as follows:
CHAPTER 446. OFF-LABEL USE OF PRESCRIPTION DRUGS
Sec. 446.001. 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. 446.002. 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. 446.003. PROHIBITED DISCIPLINARY ACTION AGAINST
PHYSICIAN'S OR PHARMACIST'S LICENSE. (a) Except as provided by
Subsection (b), 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; or
(2) communicating or otherwise promoting to a patient
an off-label use of a prescription drug.
(b) The state agency with licensing or regulatory authority
over a physician or pharmacist may revoke, fail to renew, suspend,
or take any other adverse action against a physician's or
pharmacist's license based on conduct described by Subsection
(a)(1) or (2) if, after notice and hearing, the agency proves beyond
a reasonable doubt that:
(1) the conduct caused the physician's or pharmacist's
patient to suffer physical harm; and
(2) the initial onset of the patient's physical harm
occurred not later than three years after the date of the
physician's or pharmacist's conduct.
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, 2025.