HEALTH AND SAFETY CODE

TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES

SUBTITLE C. SUBSTANCE ABUSE REGULATION AND CRIMES

Chapter 491, consisting of Secs. 491.001 to 491.151, was added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2.

For another Chapter 491, consisting of Secs. 491.001 to 491.151, added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1, see Sec. 491.001 et seq., post.

For another Chapter 491, consisting of Secs. 491.001 to 491.103, added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, see Sec. 491.001 et seq., post.

CHAPTER 491.  PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS

SUBCHAPTER A.  GENERAL PROVISIONS

Sec. 491.001.  DEFINITION.  In this chapter, "investigational sun protection product" means a sun protection product containing an ingredient that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and remains under investigation in the clinical trial.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

SUBCHAPTER B.  ELIGIBLE PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS

Sec. 491.051.  PATIENT ELIGIBILITY.  A patient is eligible to access and use an investigational sun protection product if the patient's physician:
(1)  in consultation with the patient, has considered all other sun protection products currently approved by the United States Food and Drug Administration and determined those products are less effective in comparison to an investigational sun protection product; and
(2)  recommends or prescribes in writing an investigational sun protection product for the patient.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

Sec. 491.052.  INFORMED CONSENT.  (a)  Before recommending or prescribing an investigational sun protection product, a physician must require an eligible patient to sign a written informed consent form.
(b)  If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf.
(c)  The Texas Medical Board by rule may adopt a form for the informed consent required under this section.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

Sec. 491.053.  PROVISION OF INVESTIGATIONAL SUN PROTECTION PRODUCT.  (a)  A manufacturer of an investigational sun protection product may make available in accordance with this chapter and any rules adopted under this chapter the manufacturer's product to eligible patients who provide to the manufacturer the informed consent required under Section 491.052.
(b)  This chapter does not require a manufacturer to make available an investigational sun protection product to an eligible patient.
(c)  A manufacturer may:
(1)  provide an investigational sun protection product to an eligible patient without receiving compensation; or
(2)  require an eligible patient to pay the manufacturer's costs of, or costs associated with, the manufacture of the product.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

Sec. 491.054.  NO CAUSE OF ACTION CREATED.  This chapter does not create a private or state cause of action against a manufacturer of an investigational sun protection product or against any other person or entity involved in the care of an eligible patient using the product for any harm to the eligible patient resulting from the product.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

Sec. 491.055.  STATE MAY NOT INTERFERE WITH ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS.  An official, employee, or agent of this state may not block or attempt to block an eligible patient's access to an investigational sun protection product under this chapter.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

SUBCHAPTER C.  HEALTH INSURANCE

Sec. 491.101.  EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL TRIAL ENROLLEES.  This chapter does not affect the coverage of enrollees in clinical trials under Chapter 1379, Insurance Code.
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.

SUBCHAPTER D.  PHYSICIANS

Sec. 491.151.  PROHIBITED ACTION AGAINST PHYSICIAN'S LICENSE.  Notwithstanding any other law, the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician's license under Subchapter B, Chapter 164, Occupations Code, based solely on the physician's recommendation to or prescription for an eligible patient regarding access to an investigational sun protection product, provided the recommendation or prescription for the patient meets the medical standard of care and the requirements of this chapter. 
Added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025.