§ 26-4-6. Provisions of chapter not applicable to facilities engaged solely in distribution of dialysate drugs or certain dialysis equipment under certain conditions

GA Code § 26-4-6 (2018) (N/A)
Copy with citation
Copy as parenthetical citation

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

(2) The dialysate drugs, or devices are lawfully held by a manufacturer or manufacturer's agent that is properly registered with the board as a manufacturer or wholesale distributor;

(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 manufacturer's agent and only upon receipt of a physician's order; and

(5) The manufacturer or manufacturer's agent delivers the dialysate drugs, or devices directly to:

(A) A patient with end stage renal disease or such patient's designee for the patient's self-administration of the dialysis therapy; or

(B) A health care provider or institution for administration or delivery of the dialysis therapy to a patient with end stage renal disease.