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<section article="gho" article_name="Health Occupations" number="12-603" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products">
  <level label="a">
    <level label="1">
      <text>In this section the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <text>“Dialysis drugs and devices” means:</text>
      <level label="i">
        <text>Dialysate and dialysis solutions;</text>
      </level>
      <level label="ii">
        <text>Dialyzers, delivery systems, and their accessory equipment necessary to administer these products;</text>
      </level>
      <level label="iii">
        <text>Heparin;</text>
      </level>
      <level label="iv">
        <text>Local anesthetics and any other drugs and devices approved by the Board under subsection (g) of this section;</text>
      </level>
      <level label="v">
        <text>Needles;</text>
      </level>
      <level label="vi">
        <text>Syringes; and</text>
      </level>
      <level label="vii">
        <text>Sterile sodium chloride and sterile potassium chloride.</text>
      </level>
    </level>
    <level label="3">
      <text>“Home dialysis distribution permit” means a permit issued by the Board to distribute dialysis drugs and devices to the homes of dialysis patients.</text>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>Except as provided under this subsection, a person shall hold a home dialysis distribution permit issued by the Board before the person may distribute dialysis drugs and devices to the home of a dialysis patient.</text>
    </level>
    <level label="2">
      <text>A licensed pharmacist may distribute dialysis drugs and devices under this section without the home dialysis distribution permit otherwise required by this section.</text>
    </level>
  </level>
  <level label="c">
    <text>To qualify for a home dialysis distribution permit, an applicant shall satisfy the Board that the applicant will distribute dialysis drugs and devices in compliance with subsection (h) of this section.</text>
  </level>
  <level label="d">
    <text>To apply for a home dialysis distribution permit, an applicant shall:</text>
    <level label="1">
      <text>Submit an application to the Board on the form that the Board requires; and</text>
    </level>
    <level label="2">
      <text>Pay to the Board a fee set by the Board.</text>
    </level>
  </level>
  <level label="e">
    <text>The Board shall issue a home dialysis distribution permit to any applicant who meets the requirements of this section.</text>
  </level>
  <level label="f">
    <text>A home dialysis distribution permit issued under this section authorizes the home dialysis distribution permit holder to distribute dialysis drugs and devices to the home of a dialysis patient while the home dialysis distribution permit is effective.</text>
  </level>
  <level label="g">
    <level label="1">
      <text>The Board may approve local anesthetics and other drugs and devices for distribution as dialysis drugs and devices under this section.</text>
    </level>
    <level label="2">
      <text>The Board may adopt rules and regulations to assure safe, proper, and uninterrupted distribution of dialysis drugs and devices, including rules and regulations as to:</text>
      <level label="i">
        <text>Maintaining facilities that are adequate to assure proper security and control of dialysis drugs and devices;</text>
      </level>
      <level label="ii">
        <text>Keeping records;</text>
      </level>
      <level label="iii">
        <text>Labeling dialysis drugs and devices;</text>
      </level>
      <level label="iv">
        <text>Receipts and returns from patients for dialysis drugs and devices;</text>
      </level>
      <level label="v">
        <text>Reports to the Board; and</text>
      </level>
      <level label="vi">
        <text>Restrictions on specific dialysis drugs or devices, including limitations on the amounts that may be distributed.</text>
      </level>
    </level>
  </level>
  <level label="h">
    <text>A person authorized to distribute dialysis drugs and devices under this section may distribute only dialysis drugs and devices:</text>
    <level label="1">
      <text>That the Board, after consultation with the State Commission on Kidney Disease, has approved as effective and safe for their intended use;</text>
    </level>
    <level label="2">
      <text>Under supervision of a person who the Board considers qualified to safeguard and protect the public health;</text>
    </level>
    <level label="3">
      <text>To an individual:</text>
      <level label="i">
        <text>Who has irreversibly lost function of the individual’s kidneys and requires regular treatment; and</text>
      </level>
      <level label="ii">
        <text>Who has completed a full course of training in providing the individual’s own dialysis treatment given by:</text>
        <level label="1">
          <text>A home dialysis training facility; or</text>
        </level>
        <level label="2">
          <text>An end stage renal disease clinic certified under Medicare; and</text>
        </level>
      </level>
    </level>
    <level label="4">
      <text>In compliance with the rules and regulations adopted by the Board under this section.</text>
    </level>
  </level>
  <level label="i">
    <text>Subject to the Administrative Procedure Act, the Board may suspend or revoke the home dialysis distribution permit of any home dialysis distribution permit holder who fails to comply with subsection (h) of this section.</text>
  </level>
</section>
