<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 20:51:31 STERILE COMPOUNDING PRACTICES</title> <META NAME="Keywords" Content="Administrative Rules 20:51:31"> <META NAME="Description" Content="Administrative Rules 20:51:31 STERILE COMPOUNDING PRACTICES"> <style> <!-- --> </style> </head> <body lang=EN-US> <div> <p align=center><b>CHAPTER <a href="DisplayRule.aspx?Rule=20:51:31">20:51:31</a></b></p> <p align=center><b>&nbsp;</b></p> <p align=center><b>STERILE COMPOUNDING PRACTICES</b></p> <p>Section</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:01">20:51:31:01</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Definitions.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:02">20:51:31:02</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Standards and procedures.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:03">20:51:31:03</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manual required.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:04">20:51:31:04</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Physical environment requirements for sterile products.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:05">20:51:31:05</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Requirement for primary engineering control device or room.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:06">20:51:31:06</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Placement of primary engineering control device.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:07">20:51:31:07</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Compounding aseptic isolator (CAI).</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:08">20:51:31:08</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Exception for placement of CAI.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:09">20:51:31:09</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ante area requirements.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:10">20:51:31:10</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Delayed implementation.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:11">20:51:31:11</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Cleaning, maintenance, and supplies.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:12">20:51:31:12</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Additional records required.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:13">20:51:31:13</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Quality assurance.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:14">20:51:31:14</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Pharmacist responsibilities.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:15">20:51:31:15</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Training documentation.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:16">20:51:31:16</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Reference requirements.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:17">20:51:31:17</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Labeling requirements.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:18">20:51:31:18</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Microbial contamination risk levels.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:19">20:51:31:19</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Low-risk preparations.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:20">20:51:31:20</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Medium-risk preparations.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:21">20:51:31:21</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High-risk preparations.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:22">20:51:31:22</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Immediate-use preparations.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:23">20:51:31:23</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Utilization of single-dose and multiple-dose containers.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:24">20:51:31:24</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Utilization of proprietary bag and vial systems.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:25">20:51:31:25</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Sterilization methods.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:26">20:51:31:26</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Media-fill testing by personnel.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:27">20:51:31:27</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Environmental monitoring requirements.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:28">20:51:31:28</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Storage and delivery of sterile preparations.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:29">20:51:31:29</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Additional requirements for preparation of hazardous drugs.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:30">20:51:31:30</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsibilities for patient care.</p> <p><a href="DisplayRule.aspx?Rule=20:51:31:31">20:51:31:31</a>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Patient or caregiver education and training.</p> </div> </body> </html>