<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.s5dc40d80-3213-46dc-8537-02b36d0324a0P0 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; } span.s5dc40d80-3213-46dc-8537-02b36d0324a0C0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5dc40d80-3213-46dc-8537-02b36d0324a0000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000003 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } </style></head><body><div><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=20:51:21:05.01"><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000000">20:51:21:05.01</span></a><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000001">.  Recall of a drug in unit dose distribution system.</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> If a specific </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">repackaged </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">drug is recalled, all doses labeled with the lot number of the recalled drug </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">must</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> be removed from the unit dose </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">distribution </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">system. </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">A</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">ll doses of that drug not labeled with a lot number </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">must</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> be removed from the unit dose </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">distribution </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">system.</span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0000002"> </span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">    </span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">For the purpose of this section,  Unit dose distribution system," means a drug distribution system that is in a pharmacy outlet, hospital, or other health care facility and uses unit dose packages, or unit of issue packages, labeled in accordance with § </span><a href="https://sdlegislature.gov/Rules?Rule=20:51:21:05"><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000003">20:51:21:05</span></a><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> and preserves the identity of the drug until the time of administration</span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">.</span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0000002"> </span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">    </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000001">Source:</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> 9 SDR 14, effective August 8, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002</span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">; 50 SDR 138, effective June 2, 2024</span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">.</span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">    </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000001">General Authority:</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-11"><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000003">36-11-11</span></a><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">(1).</span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">    </span><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000001">Law Implemented:</span><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-2.2"><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0-000003">36-11-2.2</span></a><span class="s5dc40d80-3213-46dc-8537-02b36d0324a0C0">.</span></p><p dir="ltr" class="s5dc40d80-3213-46dc-8537-02b36d0324a0P0"><span xml:space="preserve" class="s5dc40d80-3213-46dc-8537-02b36d0324a0000002"> </span></p></div></body></html>