88R2337 KKR-D
By: Perry S.B. No. 265
A BILL TO BE ENTITLED
AN ACT
relating to required reports of certain vaccine-related or
drug-related injuries and adverse events.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter A, Chapter 161, Health and Safety
Code, is amended by adding Section 161.0103 to read as follows:
Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED
INJURIES AND ADVERSE EVENTS. (a) This section applies only to a
vaccine that is:
(1) experimental or investigational; or
(2) approved or authorized for emergency use by the
United States Food and Drug Administration.
(b) Notwithstanding any other law, for a vaccine to which
this section applies a physician shall report to the federal
Vaccine Adverse Event Reporting System:
(1) each potential vaccine-related injury of a patient
the physician treats; and
(2) any adverse event following the patient's
vaccination.
(c) A physician who violates this section is subject to
disciplinary action by the Texas Medical Board as if the physician
violated Subtitle B, Title 3, Occupations Code.
(d) The executive commissioner shall adopt rules necessary
to implement this section.
SECTION 2. Subchapter E, Chapter 431, Health and Safety
Code, is amended by adding Section 431.1145 to read as follows:
Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED
INJURIES AND ADVERSE EVENTS. (a) This section applies only to a
drug that is:
(1) experimental or investigational; or
(2) approved or authorized for emergency use by the
United States Food and Drug Administration.
(b) Notwithstanding any other law, for a drug to which this
section applies a physician shall report to the United States Food
and Drug Administration through the MedWatch Reporting System:
(1) each potential drug-related injury of a patient
the physician treats; and
(2) any adverse event following the administration or
use of the drug.
(c) A physician who violates this section is subject to
disciplinary action by the Texas Medical Board as if the physician
violated Subtitle B, Title 3, Occupations Code.
(d) The executive commissioner shall adopt rules necessary
to implement this section.
SECTION 3. As soon as practicable after the effective date
of this Act, the executive commissioner of the Health and Human
Services Commission shall adopt rules necessary to implement the
changes in law made by this Act.
SECTION 4. This Act takes effect September 1, 2023.