Texas Health and Safety Code - HEALTH & SAFETY § 431.1145. Required Report of Certain Drug-Related Adverse Events

(1) results in death;

(2) is considered life-threatening;

(3) results in inpatient hospitalization or an extension of the duration of an existing hospitalization;

(4) results in a persistent or significant incapacity or substantial disruption of an individual's ability to perform normal life functions;

(5) results in a congenital anomaly or birth defect;  or

(6) results in a medically important medical condition that, based on the physician's reasonable medical judgment, may require medical or surgical intervention to prevent an outcome described by Subdivisions (1) through (5).

(1) experimental or investigational;  or

(2) authorized or approved for emergency use by the United States Food and Drug Administration.

(1) the physician:

(2) the patient suffers the serious adverse event before the first anniversary of the date the patient was administered or used the drug.

(1) for an initial violation, non-disciplinary corrective action by the Texas Medical Board;  and

(2) for each subsequent violation, disciplinary action by the Texas Medical Board as if the physician violated Subtitle B, Title 3, Occupations Code.