Louisiana 2022 2022 Regular Session

Louisiana House Bill HB497 Comm Sub / Analysis

                    DIGEST
The digest printed below was prepared by House Legislative Services.  It constitutes no part of the
legislative instrument.  The keyword, one-liner, abstract, and digest do not constitute part of the law
or proof or indicia of legislative intent.  [R.S. 1:13(B) and 24:177(E)]
HB 497 Engrossed	2022 Regular Session	Turner
Abstract:  Exempts from the provisions of the La. Pharmacy Practice Act facilities that provide
home dialysis drugs or devices and meet certain specifications.
Proposed law stipulates that nothing in the La. Pharmacy Practice Act (present law, 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.
(Amends R.S. 37:1250)