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<chapter num="39" heading="Pharmacist Administration of Self-Administered Drugs" title_num="10" subtitle_num="34">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice.</text>
  </regulation>
  <regulation prefix="Regulation" num=".02" 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>“Board” means the State Board of Pharmacy.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Pharmacy Experiential Program” means a program under the American Council on Pharmacy Education.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Practice Pharmacy.</text>
        <paragraph num="(a)">
          <text>“Practice pharmacy” means to engage in any of the following activities:</text>
          <paragraph num="(i)">
            <text>Providing pharmaceutical care;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Compounding, dispensing, or distributing prescription drugs or devices;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Compounding or dispensing nonprescription drugs or devices;</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Monitoring prescriptions and nonprescription drugs or devices;</text>
          </paragraph>
          <paragraph num="(v)">
            <text>Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices;</text>
          </paragraph>
          <paragraph num="(vi)">
            <text>Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices;</text>
          </paragraph>
          <paragraph num="(vii)">
            <text>Acting within the parameters of a therapy management contract, as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; or</text>
          </paragraph>
          <paragraph num="(viii)">
            <text>Administering vaccinations in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland or self-administered drugs in accordance with Health Occupations Article, §12-509, Annotated Code of Maryland.</text>
          </paragraph>
          <paragraph num="(ix)">
            <text>Delegating a pharmacy act to a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program;</text>
          </paragraph>
          <paragraph num="(x)">
            <text>Supervising a delegated pharmacy act performed by a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program; or</text>
          </paragraph>
          <paragraph num="(xi)">
            <text>Providing drug therapy management in accordance with Health-General Article, §19-713.6, Annotated Code of Maryland.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>“Practice pharmacy” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12-602, Annotated Code of Maryland.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>“Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Self-Administered Drug.</text>
        <paragraph num="(a)">
          <text>“Self-administered drug” means a drug that is regularly administered by the patient for whom the drug is prescribed or by an individual who is not otherwise authorized to administer drugs under Health Occupations Article, §12-509, Annotated Code of Maryland.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Self–administered drug” includes:</text>
          <paragraph num="(i)">
            <text>Eye drops;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A drug that is administered by an intramuscular injection or a subcutaneous injection;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Ear drops;</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Inhalation therapies;</text>
          </paragraph>
          <paragraph num="(v)">
            <text>Intranasal therapies; and</text>
          </paragraph>
          <paragraph num="(vi)">
            <text>Topical therapies.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Requirements to Administer Self-Administered Drugs.">
    <paragraph num="A.">
      <text>A licensed pharmacist shall attest that the pharmacist has the appropriate training in administration of self-administered drugs that consists of instruction on:</text>
      <paragraph num="(1)">
        <text>Ear drops;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Eye drops;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Inhalation therapies;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Intramuscular injections;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Intranasal therapies;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Subcutaneous injections; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Topical therapies.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A licensed pharmacist shall possess an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction.</text>
    </paragraph>
    <paragraph num="C.">
      <text>A licensed pharmacist, certified under Health Occupations Article, §12-508, Annotated Code of Maryland, is deemed to have satisfied the training requirements in this chapter.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A licensed pharmacist may administer a self-administered drug in accordance with a prescription.</text>
    </paragraph>
    <paragraph num="E.">
      <text>A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, may administer a self-administered drug under direct supervision of a licensed pharmacist who meets the requirements in §A or B of this regulation.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Record Keeping.">
    <paragraph num="A.">
      <text>The pharmacist shall document in the patient record the administration of a self-administered drug that includes the following information:</text>
      <paragraph num="(1)">
        <text>Name of the drug;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Dosage administered;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Site of administration;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Date and time of administration; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Any instructions provided to the patient.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The patient record shall be maintained for 5 years, unless otherwise required by law, and be:</text>
      <paragraph num="(1)">
        <text>Readily retrievable; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Made available on the request of the Board.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-Occupations Article, §§12-101, 12-102(b), and 12-509, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: May 9, 2016 (43:9 Md. R. 530)</annotation>
  </annotations>
</chapter>