<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.13.01.04" title_num="10" subtitle_num="13" chapter_num="01" heading="Dispensing Requirements.">
  <paragraph num="A.">
    <text>A licensee shall submit an application to the appropriate Board on the form that the Board requires.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A licensee may not dispense prescription drugs until a written permit is received from the appropriate Board, except that a written permit is not required in order to dispense starter dosages or samples provided without charge.</text>
  </paragraph>
  <paragraph num="C.">
    <text>A licensee shall personally prepare and dispense prescription drugs.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Except as provided in Health Occupations Article, §12-102(c)(2)(iii), Annotated Code of Maryland, and §S of this regulation, a licensee shall dispense prescription drugs only to the patients of the licensee.</text>
  </paragraph>
  <paragraph num="E.">
    <text>A licensee shall comply with the labeling requirements set forth in Health Occupations Article, §12-505, Annotated Code of Maryland.</text>
  </paragraph>
  <paragraph num="F.">
    <text>A licensee shall comply with the child resistant packaging requirements set forth in Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland.</text>
  </paragraph>
  <paragraph num="G.">
    <text>A licensee shall comply with drug recalls.</text>
  </paragraph>
  <paragraph num="H.">
    <text>A licensee shall record the dispensing of the prescription drug on the patient's chart.</text>
  </paragraph>
  <paragraph num="I.">
    <text>A licensee may not have a substantial financial interest in a pharmacy.</text>
  </paragraph>
  <paragraph num="J.">
    <text>A licensee shall, except for starter dosages or samples provided without charge, provide the patient with a written prescription.</text>
  </paragraph>
  <paragraph num="K.">
    <text>A licensee shall maintain for at least 5 years:</text>
    <paragraph num="(1)">
      <text>A separate file for Schedule II prescriptions; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Another file for other prescriptions.</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>A licensee shall maintain biennial inventories of all stocks of controlled substances.</text>
  </paragraph>
  <paragraph num="M.">
    <text>A licensee shall dispense prescription drugs to a patient only when the patient determines that a pharmacy is not conveniently available to the patient.</text>
  </paragraph>
  <paragraph num="N.">
    <text>In each patient’s chart for each patient to whom prescription drugs are dispensed or in a format readily retrievable, a licensee shall maintain a single form which:</text>
    <paragraph num="(1)">
      <text>Indicates that a pharmacy is not conveniently available to the patient;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>States that the determination that a pharmacy is not conveniently available was made solely by the patient; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Is signed and dated by the patient before dispensing prescription drugs to the patient for the first time.</text>
    </paragraph>
  </paragraph>
  <paragraph num="O.">
    <text>A licensee shall display prominently a sign which informs the patient that prescription drugs can be purchased from the permit holder if the patient determines that a pharmacy is not conveniently available to the patient.</text>
  </paragraph>
  <paragraph num="P.">
    <text>A licensee may not make any agreement that denies a patient a free choice of pharmacist or pharmacy services.</text>
  </paragraph>
  <paragraph num="Q.">
    <text>A licensee shall post a sign conspicuously positioned and readable regarding the process for resolving incorrectly filled prescriptions or includes written information regarding the process with each prescription dispensed.</text>
  </paragraph>
  <paragraph num="R.">
    <text>A licensee shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary to prepare and dispense prescriptions properly.</text>
  </paragraph>
  <paragraph num="S.">
    <text>To the extent permitted by COMAR 10.32.23, a licensed physician may personally prepare and dispense a prescription written by:</text>
    <paragraph num="(1)">
      <text>A physician assistant with whom the physician has a delegation agreement that:</text>
      <paragraph num="(a)">
        <text>Complies with Health Occupations Article, Title 15, Subtitle 3, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Permits the physician assistant to prescribe the drug; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A certified registered nurse practitioner who is:</text>
      <paragraph num="(a)">
        <text>Authorized to practice under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Working with the physician in the same practice.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>