<html> <head> <title>Rule 20:51:05:23 Distribution of dialysate or dialysis devices by the manufacturer or manufacturer's agent to a patient - Exempt from pharmacy licensure.</title> <META NAME="Keywords" Content="Administrative Rules 20:51:05:23"> <META NAME="Description" Content="Administrative Rules 20:51:05:23 Distribution of dialysate or dialysis devices by the manufacturer or manufacturer's agent to a patient - Exempt from pharmacy licensure."> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Generator content="Microsoft Word 15 (filtered)"> <style> <!-- /* Font Definitions */ @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4;} @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {margin-top:0in; margin-right:0in; margin-bottom:10.0pt; margin-left:0in; line-height:115%; font-size:11.0pt; font-family:"Calibri",sans-serif;} a:link, span.MsoHyperlink {color:blue; text-decoration:underline;} a:visited, span.MsoHyperlinkFollowed {color:purple; text-decoration:underline;} .MsoChpDefault {font-family:"Calibri",sans-serif;} .MsoPapDefault {margin-bottom:10.0pt; line-height:115%;} @page WordSection1 {size:8.5in 11.0in; margin:49.7pt 1.0in 49.7pt 63.35pt;} div.WordSection1 {page:WordSection1;} --> </style> </head> <body lang=EN-US link=blue vlink=purple> <div class=WordSection1> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>20</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>:</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>51</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>:</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>05</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>:</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>23</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>.&nbsp;&nbsp;Distribution of dialysate or dialysis devices by</span></b><b><span style='font-size:12.0pt; font-family:"Times New Roman",serif'> the</span></b><b><span style='font-size: 12.0pt;font-family:"Times New Roman",serif'> manufacturer or manufacturer</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>'</span></b><b><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>s agent to a patient - Exempt from pharmacy licensure.</span></b><span style='font-size: 12.0pt;font-family:"Times New Roman",serif'> A manufacturer of dialysate and dialysis devices or an agent of a manufacturer may ship dialysate and dialysis devices directly to a patient in this state, to an agent of the patient, or to a health care practitioner or institution, for administration or delivery of dialysis therapy, to a patient with chronic kidney failure, without being licensed as a pharmacy in this state if the following criteria have been met:</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>(1)</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>The manufacturer or manufacturer</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>'</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>s agent shipping the dialysate is licensed as a wholesaler or other drug distributor;</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>(2)</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>The dialysate is stored and delivered in the original, sealed, and labeled package from the manufacturing facility; and</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>(3)</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>The dialysate or dialysis devices are delivered only upon receipt of a prescription order issued by a licensed practitioner and only if an order from a licensed pharmacy is transmitted to the manufacturer or the manufacturer's agent.</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Records for all sales and distribution of dialysate must be retained and readily available for inspection for a period of two years from the date of the transaction.</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 47 SDR 42, effective October 12, 2020.</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b> SDCL </span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>36-11-11(1).</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b> SDCL </span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>36-11-11(1)</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>.</span></p> <p class=MsoNormal style='margin-bottom:0in;margin-bottom:.0001pt;text-align: justify;line-height:normal'><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>&nbsp;</span></p> </div> </body> </html>