Louisiana 2022 2022 Regular Session

Louisiana House Bill HB497 Comm Sub / Analysis

                    RÉSUMÉ DIGEST
ACT 154 (HB 497) 2022 Regular Session	Turner
New law stipulates that nothing in the La. Pharmacy Practice Act (R.S. 37:1161 et seq.) shall
apply to a facility which engages solely in the distribution of dialysate, drugs, or devices
necessary to perform home kidney dialysis to patients with end stage renal disease if all of
the following criteria are met:
(1)The dialysate, drugs, or devices are approved or cleared by the U.S. 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 La. Board of Pharmacy as a distributor of
legend drugs or legend devices.
(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.
(5)The manufacturer or manufacturer's agent delivers the dialysate, drugs, or devices
directly to any of the following parties:
(a)A patient with end stage renal disease, or his designee, for self-administration
of the dialysis therapy by the patient.
(b)A healthcare provider or institution for administration or delivery of the
dialysis therapy to a patient with end stage renal disease.
Effective August 1, 2022.
(Amends R.S. 37:1250)