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LAWS OF DELAWARE
VOLUME 85
CHAPTER 97
153rd GENERAL ASSEMBLY
FORMERLY
SENATE BILL NO. 182
AN ACT TO AMEND TITLE 24 OF THE DELAWARE CODE RELATING TO PHARMACY.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
Amend § 2523, Title 24 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:
§ 2523. Exemptions.
Nothing in this chapter may be construed to prevent any of the following:
(10) A manufacturer or wholesaler from providing distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease, provided that all of the following criteria are met:
a. The dialysate drugs or devices are approved by the U. S. Food and Drug Administration as required by federal law.
b. The dialysate drugs or devices are lawfully held by a manufacturer or a manufacturer’s agent that is properly registered with the Board as a manufacturer or wholesaler.
c. The dialysate drugs or devices are held and delivered in their original, sealed label packaging from the manufacturing facility.
d. The dialysate drugs or devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt of a prescription from a practitioner.
e. The manufacturer or the manufacturer’s agent delivers the dialysate drugs or devices directly to one of the following:
1. A patient with end stage renal disease or the patient’s designee for the patient’s self-administration of dialysis therapy.
2. A health care provider or institution for administration or delivery of the dialysis therapy to a patient with end stage renal disease.
Approved July 21, 2025