<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 10.34.19.07" title_num="10" subtitle_num="34" chapter_num="19" heading="Record-Keeping Requirements.">
  <paragraph num="A.">
    <text>Patient Prescription Records.</text>
    <paragraph num="(1)">
      <text>The pharmacy shall maintain records of patient prescriptions.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Patient prescription records shall contain:</text>
      <paragraph num="(a)">
        <text>Available medical information consistent with prevailing pharmacy standards; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The complete record of the formulations of the solutions that were compounded.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The pharmacy shall keep completed patient prescription records in a retrievable manner for at least 5 years, either:</text>
      <paragraph num="(a)">
        <text>At the inspection site; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>So as to be immediately retrievable by computer or other electronic means.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Compounded Sterile Preparations Records.</text>
    <paragraph num="(1)">
      <text>For a pharmacy preparing compounded sterile preparations, the following records shall be maintained for at least 5 years:</text>
      <paragraph num="(a)">
        <text>The training and competency evaluation of employees in sterile preparation procedures;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Refrigerator and freezer temperatures;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Certification of the sterile compounding environment, including ISO 5 workstations and the clean and anterooms;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Other facility quality control logs specific to the pharmacy's policies and procedures, for example, cleaning logs for facilities and equipment;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Records documenting inspection for expired or recalled pharmaceutical preparations or raw ingredients;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Preparation records including compounding work sheets, and records of the registered pharmacy technicians' checking/sign-off process; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Preparation records including compounding work sheets and records of the pharmacists' checking/sign-off process.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a pharmacy compounding sterile batch preparations for future use shall have records indicating the:</text>
      <paragraph num="(a)">
        <text>Drug and ingredient names;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Lot numbers;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Expiration dates;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Drug/diluent amounts; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Date on which the compounded sterile batch preparations were prepared.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A pharmacy shall maintain records of media fill verification results for 5 years.</text>
    </paragraph>
  </paragraph>
</regulation>