Bill > SB182

This bill amends Delaware's pharmacy regulations to create a specific exemption allowing drug manufacturers or their agents and wholesalers to directly ship dialysate drugs and devices to home dialysis patients without needing a pharmacy license. The bill establishes five key criteria for this direct distribution: (1) the drugs or devices must be FDA-approved, (2) the manufacturer or agent must be properly registered with the Board, (3) the items must be in original, sealed packaging from the manufacturing facility, (4) delivery must occur only upon receipt of a prescription from a healthcare practitioner, and (5) delivery can be made either directly to the end-stage renal disease patient (or their designee) for self-administration or to a healthcare provider/institution for patient treatment. This provision aims to simplify the process of obtaining home dialysis supplies by allowing manufacturers to ship these specialized medical products directly to patients or their healthcare providers, potentially improving access and convenience for individuals managing end-stage renal disease.

Government Affairs, Health and Social Services

https://legis.delaware.gov/BillDetail?LegislationId=142489