HB260 By Representative Beech RFD Health Rd 1 18-FEB-16

SYNOPSIS: This bill would exempt certain facilities engaged solely in the distribution of dialysate, drugs, or devices necessary to perform home renal dialysis to patients with chronic kidney failure from regulation by the Alabama State Board of Pharmacy.

A BILL TO BE ENTITLED AN ACT

To add Section 34-23-77 to the Code of Alabama 1975, to exempt certain facilities engaged solely in the distribution of dialysate, drugs, or devices necessary to perform home renal dialysis to patients with chronic kidney failure from regulation by the Alabama State Board of Pharmacy.

BE IT ENACTED BY THE LEGISLATURE OF ALABAMA:

Section 1. Section 34-23-77 is added to the Code of Alabama 1975, to read as follows:

§34-23-77. A facility engaged solely in the distribution of dialysate, drugs, or devices necessary to perform home renal dialysis to patients with chronic kidney failure, is exempt from regulation by the Alabama State Board of Pharmacy provided all of the following criteria are satisfied:

(1) The dialysate, drugs, or devices are approved or cleared by the Food and Drug Administration, as required by federal law.

(2) The dialysate, drugs, or devices are lawfully held by a manufacturer, or the agent of a manufacturer, that is properly registered with the board as a manufacturer or wholesaler, or both.

(3) The dialysate, drugs, or devices are held and delivered in their original, sealed packaging from the manufacturing facility.

(4) The dialysate, drugs, or devices are delivered only by the manufacturer, or the agent of the manufacturer, and only upon receipt of the order of a physician.

(5) The manufacturer, or agent of the manufacturer, delivers the dialysate, drugs, or devices directly to any of the following:

a. A patient with chronic kidney failure, or his or her designee, for self-administration by the patient of the dialysis therapy.

b. A health care provider or institution for administration or delivery of the dialysis therapy to a patient with chronic kidney failure.

Section 2. This act shall become effective on the first day of the third month following its passage and approval by the Governor, or its otherwise becoming law.

Pharmacy, Alabama State Board of

Dialysis

Health

Code Added