<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.s5873ae11-1c02-41d5-8f31-d63f69983577P0 { 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.s5873ae11-1c02-41d5-8f31-d63f69983577C0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5873ae11-1c02-41d5-8f31-d63f69983577C0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s5873ae11-1c02-41d5-8f31-d63f69983577000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5873ae11-1c02-41d5-8f31-d63f69983577C3 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s5873ae11-1c02-41d5-8f31-d63f69983577C0-000003 { 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="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=20:51:31:37"><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000000">20:51:31:37</span></a><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">.  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">Quality assurance</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">.</span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0"> </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">Any pharmacy that compounds prescriptions must have a quality assurance program with the following elements</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">:</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">(1)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">A documented, ongoing program for the monitoring of personnel, components, equipment, and facilities used for preparation of compounded pharmaceuticals that conforms to applicable state and federal law</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">;</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">(2)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">If errors have occurred, the pharmacist-in-charge is responsible for conducting a full investigation. A written record of the investigation must be completed and include conclusions and follow-up</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">;</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    (3)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">The pharmacist-i</span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C3">n-charge </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">is responsible for proper maintenance, cleanliness, and use of facilities and equipment used in compounding</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">;</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    (4)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">All pharmacists and pharmacy technicians, who assist in compounding drug products, must have documented training and competency testing as required by state and federal law;</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    (5)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">Training must be conducted by qualified individuals on a continuing basis with frequencies outlined in United States Pharmacopeia to ensure that compounding pharmacy personnel remain up to date with operations, policies, and procedures</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">;</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    (6)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">Only personnel authorized by the pharmacist-in-charge may be in the immediate vicinity of compounding operations; and</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    (7)  </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">A compounded drug is adulterated if it has been prepared, packed, or held under insanitary conditions. For the purpose of this section,  insanitary conditions means a condition of exposure to contamination with filth which may be rendered injurious to health</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">.</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">Source:</span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0"> </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">50 SDR 138, effective June 2, 2024</span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">.</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">General Authority:</span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-11"><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000003">36-11-11</span></a><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">(3).</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">    </span><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000001">Law Implemented:</span><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0"> SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-2.2"><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000003">36-11-2.2</span></a><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">(3), </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-42"><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000003">36-11-42</span></a><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=36-11-46"><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0-000003">36-11-46</span></a><span class="s5873ae11-1c02-41d5-8f31-d63f69983577C0">.</span></p><p dir="ltr" class="s5873ae11-1c02-41d5-8f31-d63f69983577P0"><span xml:space="preserve" class="s5873ae11-1c02-41d5-8f31-d63f69983577000002"> </span></p></div></body></html>