<html xmlns="http://www.w3.org/1999/xhtml"><head><meta charset="UTF-8" /><title></title><meta name="Generator" content="PowerTools for Open XML" /><style>span { white-space: pre-wrap; } p.sed4639af-1895-47ee-945d-7b28097bbd9aP0 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: Times; font-size: 12pt; line-height: 108%; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0 { color: black; background: white; font-family: Times; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0-000000 { color: #0000FF; background: white; font-family: Times; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0-000001 { color: black; background: white; font-family: Times; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9a000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0-000003 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0-000004 { color: black; background: #FFFFFF; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.sed4639af-1895-47ee-945d-7b28097bbd9aC0-000005 { color: #0000FF; background: white; font-family: Times; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } </style></head><body><div><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    </span><a href="https://sdlegislature.gov/Rules?Rule=20:51:31:01"><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000000">20:51:31:01</span></a><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000001">.  Definitions.</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0"> Terms used in this chapter mean:</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    (1)</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">  </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">"Compounding," the constitution, reconstitution, combination, dilution, or another process causing a change in the form, composition, or strength of any ingredient or any other attribute of a product;</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    (</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">2</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">)</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">  </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">"Hazardous drug," a pharmaceutical that is antineoplastic, carcinogenic, mutagenic, or teratogenic;</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    (</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">3</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">)  </span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000003"> Nonsterile compounding," </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000004">the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation; and</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    (</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">4</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">)  "Sterile compounding," the aseptic processing of any pharmaceutical preparation that </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">is</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0"> required to be sterile when administered to patients.</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000001">Source:</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0"> 36 SDR 100, effective December 14, 2009</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">; 50 SDR 138, effective June 2, 2024</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">.</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000001">General Authority:</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-11"><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000005">36-11-11</span></a><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">(1)(3).</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">    </span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000001">Law Implemented:</span><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9aC0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-2.2"><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000005">36-11-</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0-000005">2.2</span></a><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">(3)</span><span class="sed4639af-1895-47ee-945d-7b28097bbd9aC0">.</span></p><p dir="ltr" class="sed4639af-1895-47ee-945d-7b28097bbd9aP0"><span xml:space="preserve" class="sed4639af-1895-47ee-945d-7b28097bbd9a000002"> </span></p></div></body></html>