Texas Health and Safety Code - HEALTH & SAFETY § 42.0045. Distribution of Drugs and Devices

(a) Sections 483.041(a) and 483.042 of this code, Subtitle J, Title 3, Occupations Code,  1 and other applicable laws establishing prohibitions do not apply to a dialysate, device, or drug exclusively used or necessary to perform dialysis that a physician prescribes or orders for administration or delivery to a person with end stage renal disease if:

(b) The executive commissioner shall adopt rules necessary to ensure the safe distribution, without the interruption of supply, of a dialysate, device, or drug covered by Subsection (a).  The rules must include provisions regarding manufacturer and wholesaler licensing, record keeping, evidence of a delivery to a patient or a patient's designee, patient training, specific product and quantity limitation, physician prescriptions or order forms, adequate facilities, and appropriate labeling to ensure that necessary information is affixed to or accompanies the dialysate, device, or drug.

(c) If the department determines that a dialysate, device, or drug distributed under this chapter is ineffective or unsafe for its intended use, the department may immediately recall the dialysate, device, or drug distributed to an individual patient.

(d) A dialysate, device, or drug covered by Subsection (a) may be delivered only by: