A BILL TO BE ENTITLED
AN ACT amending the pharmacy practice act to create a pharmacy permit exemption and a device and medical equipment permit exemption for the dispensing and delivery of home renal products.
The General Assembly of North Carolina enacts:
SECTION 1.  Article 4A of Chapter 90 of the General Statutes is amended by adding a new section to read:
"§ 90‑85.21C.  Pharmacy permit exemption for dispensing and delivery of home renal products.
Each location or facility within or outside this State from which dialysate or drugs necessary to perform home renal dialysis are dispensed and delivered to a patient in this State is exempt from the pharmacy permit requirements established by G.S. 90‑85.21, provided that all the following criteria are met:
(1)	The dialysate or drugs have been approved or cleared by United States Food and Drug Administration.
(2)	The dialysate or drugs are lawfully held by a manufacturer or an agent of the manufacturer that is properly registered with the Board as a manufacturer or a wholesaler, or both, as required by the Board.
(3)	The dialysate or drugs are held, delivered, and dispensed in their original, sealed packaging from the manufacturing facility.
(4)	The dialysate or drugs are delivered only by the manufacturer or an agent of the manufacturer and only upon receipt of a physician's order.
(5)	The manufacturer or an agent of the manufacturer delivers the dialysate or drugs directly to either or both of the following:
a.	A patient with chronic kidney failure or a designee of the patient, for self‑administration of the dialysis therapy.
b.	A health care provider, or health care facility licensed under Chapter 122C, 131D, or 131E of the General Statutes, for administration or delivery of the dialysis therapy to a patient with chronic kidney failure.
SECTION 2.  G.S. 90‑85.22 reads as rewritten:
"§ 90‑85.22.  Device and medical equipment permits; exemptions.
…
(c)	This section shall not apply to any of the following:
(1)	A pharmaceutical manufacturer registered with the Food and Drug Administration.
(2)	A wholly owned subsidiary of a pharmaceutical manufacturer registered with the Food and Drug Administration.
(3)	The dispensing and delivery of home renal products in accordance with the criteria specified in G.S. 90‑85.21C."
SECTION 3.  This act becomes effective October 1, 2015.