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<regulation prefix="Regulation" num=".01" citation="COMAR 10.34.35.01" title_num="10" subtitle_num="34" chapter_num="35" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Alternate site care environment” means the location where the patient is receiving infusion therapy other than an inpatient hospital setting.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Compounding worksheet” means a document or electronic record which:</text>
      <paragraph num="(a)">
        <text>Specifies instructions for a specific compounded parenteral medication;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Documents the manufacturer’s:</text>
        <paragraph num="(i)">
          <text>Ingredients;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Lot numbers; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Expiration dates; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Includes a copy of the prescription label.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Delegated Pharmacy Act.</text>
      <paragraph num="(a)">
        <text>“Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Delegated pharmacy act” does not include:</text>
        <paragraph num="(i)">
          <text>An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Title 12, Subtitle 6A, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or Health Occupations Article, Title 12, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The delegation of a pharmacy act by a pharmacy technician, pharmacy student, or pharmacy technician trainee;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months; or</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>The performance of other functions prohibited in regulations adopted by the Board.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>“End of therapy” means the conclusion of parenteral infusion therapy as ordered by the prescriber.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Infusion nurse” means a registered nurse providing infusion therapy as defined in COMAR 10.27.20.02B in an alternate site environment.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Infusion pharmacy” means a pharmacy that provides pharmaceutical care to patients receiving parenteral therapy in an alternate site care environment.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Licensed authorized prescriber of record” means an individual with the authority to prescribe and monitor a patient’s parenteral infusion therapy for the duration of the patient’s infusion therapy.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Parenteral infusion access device” means, but is not limited to, intravenous, subcutaneous, intrathecal, epidural, or peripheral nerve catheter device through which parenteral medications may be administered.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Patient care plan” means an individualized care plan that reflects the patient’s parenteral infusion therapy pharmaceutical monitoring plan aimed at optimizing the outcome of therapy while minimizing untoward effects from the medication.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Patient triage form” means a written or electronic tool used by a clinician or by a registered pharmacy technician when communicating with a patient, a patient’s caregiver, or an infusion nurse to document the patient’s current status, including but not limited to, the patient’s response to therapy, medication changes or adverse reactions, and pain level.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Permit holder” means a person, corporation, or other legal entity authorized by the Board to establish and operate a pharmacy.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>“Pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Pharmacist” means an individual who is licensed to practice pharmacy.</text>
    </paragraph>
    <paragraph num="(14)">
      <text>“Supervision” means the on-site provision of management, direction, oversight and review of tasks assigned to personnel.</text>
    </paragraph>
  </paragraph>
</regulation>