<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".13" citation="COMAR 10.34.19.13" title_num="10" subtitle_num="34" chapter_num="19" heading="Attire.">
  <paragraph num="A.">
    <text>When compounding sterile preparations, individuals shall comply with the following standards:</text>
    <paragraph num="(1)">
      <text>Sequencing of garbing that complies with USP 797 Standards;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Thorough hand-washing before gowning;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Wearing clean room garb inside the designated area at all times, which consists of:</text>
      <paragraph num="(a)">
        <text>A non-shedding coverall or gown;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Head and facial hair covers;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A face mask; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Shoe covers;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Clean room garb, with the exception of sterile gloves, shall be donned and removed outside the designated clean room area;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>All jewelry shall be removed;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Sterile gloves are required; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Make-up may not be worn in the clean room.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The requirements of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with USP 797 Standards and isolator vendor/manufacturer specifications.</text>
  </paragraph>
</regulation>