Sec. 42.0045. DISTRIBUTION OF DRUGS AND DEVICES. (a) Sections 483.041(a) and 483.042 of this code, Subtitle J, Title 3, Occupations Code, 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:

(1) the dialysate, device, or drug is lawfully held by a manufacturer or wholesaler licensed by the department;

(2) the manufacturer or wholesaler delivers the dialysate, device, or drug to:

(A) a person with end stage renal disease for self-administration at the person's home or a specified address, as ordered by a physician; or

(B) a physician for administration or delivery to a person with end stage renal disease; and

(3) the manufacturer or wholesaler has sufficient and qualified supervision to adequately protect the public health.

(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:

(1) the manufacturer or wholesaler to which the physician has issued an order; or

(2) a carrier authorized to possess the dialysate, device, or drug under Section 483.041(c).

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 12, eff. Sept. 1, 1991. Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.769, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0144, eff. April 2, 2015.