<html> <head> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <title>Rule 20:67:03 DRUG STORAGE AND HANDLING REQUIREMENTS</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03"> <META NAME="Description" Content="Administrative Rules 20:67:03 DRUG STORAGE AND HANDLING REQUIREMENTS"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p align=center><b>CHAPTER 20:67:03</b></p> <p align=center><b>DRUG STORAGE AND HANDLING REQUIREMENTS</b></p> <p>Section</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:01">20:67:03:01</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Facilities.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:02">20:67:03:02</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Storage conditions.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:03">20:67:03:03</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Examination upon receipt required.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:04">20:67:03:04</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Outgoing shipments to be inspected.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:05">20:67:03:05</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Quarantine required.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:06">20:67:03:06</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Opened containers to be identified.</p> <p><a href="DisplayRule.aspx?Rule=20:67:03:07">20:67:03:07</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Standards for returned drugs to be met.</p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:01 Facilities.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:01"> <META NAME="Description" Content="Administrative Rules 20:67:03:01 Facilities."> <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:Times; panose-1:2 2 6 3 5 4 5 2 3 4;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {margin:0in; margin-bottom:.0001pt; font-size:10.0pt; font-family:"Times",serif;} a:link, span.MsoHyperlink {color:blue; text-decoration:underline;} a:visited, span.MsoHyperlinkFollowed {color:purple; text-decoration:underline;} .MsoChpDefault {font-size:10.0pt;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.0in 1.0in 1.0in;} div.WordSection1 {page:WordSection1;} --> </style> </head> <body lang=EN-US link=blue vlink=purple> <div class=WordSection1> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:01.&nbsp;&nbsp;Facilities.</b> All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall meet the following conditions:</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (1)&nbsp;&nbsp;Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (2)&nbsp;&nbsp;Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (3)&nbsp;&nbsp;Have a separate quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated,</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'> recalled,</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'> misbranded, or adulterated or that are in immediate or sealed secondary containers that have been opened;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (4)&nbsp;&nbsp;Be maintained in a clean and orderly condition;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (5)&nbsp;&nbsp;Be free from infestation by insects, rodents, birds, or vermin of any kind;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (6)&nbsp;&nbsp;Be secured from unauthorized entry by:</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (a)&nbsp;&nbsp;A well-lighted outside perimeter of the premises;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (b)&nbsp;&nbsp;An alarm system to detect entry after hours; and</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (c)&nbsp;&nbsp;A security system that provides protection against theft and diversion, including, if applicable, theft or diversion that is facilitated or hidden by tampering with computers or electronic records.</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.</span></p> <p class=MsoNormal style='text-align:justify'><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 <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7)</A>,(10).</span></p> <p class=MsoNormal style='text-align:justify'><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 <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:02 Storage conditions.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:02"> <META NAME="Description" Content="Administrative Rules 20:67:03:02 Storage conditions."> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:02.&nbsp;&nbsp;Storage conditions.</b> All prescription drugs shall be stored as required by the labeling of the drugs. If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature to help ensure that its identity, strength, quality, and purity are not adversely affected. Manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be utilized, as applicable, to document proper storage of prescription drugs.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7).</A></p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:03 Examination upon receipt required.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:03"> <META NAME="Description" Content="Administrative Rules 20:67:03:03 Examination upon receipt required."> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:03.&nbsp;&nbsp;Examination upon receipt required.</b> Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7)</A>,(13).</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:04 Outgoing shipments to be inspected.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:04"> <META NAME="Description" Content="Administrative Rules 20:67:03:04 Outgoing shipments to be inspected."> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:04.&nbsp;&nbsp;Outgoing shipments to be inspected.</b> Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7)</A>,(13).</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:05 Quarantine required.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:05"> <META NAME="Description" Content="Administrative Rules 20:67:03:05 Quarantine required."> <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:Times; panose-1:2 2 6 3 5 4 5 2 3 4;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {margin:0in; margin-bottom:.0001pt; font-size:10.0pt; font-family:"Times",serif;} a:link, span.MsoHyperlink {color:blue; text-decoration:underline;} a:visited, span.MsoHyperlinkFollowed {color:purple; text-decoration:underline;} .MsoChpDefault {font-size:10.0pt;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.0in 1.0in 1.0in;} div.WordSection1 {page:WordSection1;} --> </style> </head> <body lang=EN-US link=blue vlink=purple> <div class=WordSection1> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:05.&nbsp;&nbsp;Quarantine required.</b> Prescription drugs that are outdated, damaged, deteriorated,</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'> recalled,</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'> misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.</span></p> <p class=MsoNormal style='text-align:justify'><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 <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7).</A></span></p> <p class=MsoNormal style='text-align:justify'><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 <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7</A></span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>, 36-11A-34</span><span style='font-size:12.0pt;font-family:"Times New Roman",serif'>.</span></p> <p class=MsoNormal style='text-align:justify'><span style='font-size:12.0pt; font-family:"Times New Roman",serif'>&nbsp;</span></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:06 Opened containers to be identified.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:06"> <META NAME="Description" Content="Administrative Rules 20:67:03:06 Opened containers to be identified."> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:06.&nbsp;&nbsp;Opened containers to be identified.</b> Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7)</A>,(13).</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></p> </div> </body> </html> <br /><hr><br /><html> <head> <title>Rule 20:67:03:07 Standards for returned drugs to be met.</title> <META NAME="Keywords" Content="Administrative Rules 20:67:03:07"> <META NAME="Description" Content="Administrative Rules 20:67:03:07 Standards for returned drugs to be met."> <meta name=Generator content="Microsoft Office HTML Filter 2.0"> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Originator content="Microsoft Word 10"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>20:67:03:07.&nbsp;&nbsp;Standards for returned drugs to be met.</b> If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the drug shall be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Source:</b> 18 SDR 95, effective November 25, 1991.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>General Authority:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-14">36-11A-14(7)</A>,(13).</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b>Law Implemented:</b>SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11A-7">36-11A-7.</A></p> </div> </body> </html>