<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.34.32.03" title_num="10" subtitle_num="34" chapter_num="32" heading="Requirements to Administer Vaccinations.">
  <paragraph num="A.">
    <text>Registration.</text>
    <paragraph num="(1)">
      <text>A licensed pharmacist shall submit a registration to the Board on the form that the Board requires.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The registration form shall include verification from the licensed pharmacist of the following:</text>
      <paragraph num="(a)">
        <text>That the pharmacist has completed a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education and includes education on:</text>
        <paragraph num="(i)">
          <text>Hands-on injection techniques;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Clinical evaluation of indication and contraindications of vaccines;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The recognition and treatment of emergency reaction to vaccines; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Guidelines and recommendations of the Centers for Disease Control and Prevention regarding vaccinations in effect on December 31, 2024; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Possession of an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A registration authorizing a licensed pharmacist to administer vaccinations expires with the expiration of the license to practice pharmacy unless the licensed pharmacist has completed:</text>
      <paragraph num="(a)">
        <text>Two hours of continuing education credits related to vaccinations; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>All other requirements for licensure renewal.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A licensed pharmacist may not administer vaccinations until the licensed pharmacist receives a written confirmation from the Board accepting the licensed pharmacist's registration.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A licensed pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 3 years old provided that:</text>
    <paragraph num="(1)">
      <text>The vaccine is:</text>
      <paragraph num="(a)">
        <text>An influenza vaccine;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A COVID vaccine; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Used in response to a public health emergency; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall:</text>
      <paragraph num="(a)">
        <text>Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Refer the child vaccination patient to a pediatric care provider when appropriate.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B-1.">
    <paragraph num="(1)">
      <text>A pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 7 years old provided that:</text>
      <paragraph num="(a)">
        <text>The vaccine:</text>
        <paragraph num="(i)">
          <text>Is recommended by the Center for Disease Control and Prevention Advisory Committee on Immunization Practices; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Approved or authorized by the U.S. Food and Drug Administration; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall:</text>
        <paragraph num="(i)">
          <text>Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Refer the child vaccination patient to a pediatric care provider when appropriate.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices cited in this regulation refer to federal statutes, rules, and guidance:</text>
      <paragraph num="(a)">
        <text>In effect on December 31, 2024; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>At a later date to account for any new vaccines recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices after December 31, 2024.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B-2.">
    <text>A licensed pharmacist may order and administer to an adult a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter that is listed in the Center for Disease Control and Prevention’s Health Information for International Travel.</text>
  </paragraph>
  <paragraph num="C.">
    <text>A pharmacist shall report to the ImmuNet Program established under Health-General Article, §18-109, Annotated Code of Maryland, a vaccination administered by the pharmacist to an individual.</text>
  </paragraph>
  <paragraph num="D.">
    <text>A pharmacist shall:</text>
    <paragraph num="(1)">
      <text>Have proof of active certification in basic cardiopulmonary resuscitation readily available.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide the patient with a vaccine information statement issued by the Centers for Disease Control and Prevention;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Obtain a signed consent form from the patient or custodial parent; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Observe the patient for a period of at least 15 minutes after administration of the vaccine for adverse effects including syncope.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>A pharmacy student in a Pharmacy Experiential Program, who has successfully completed a Board-approved certification course, may administer vaccinations under direct supervision of a licensed pharmacist who meets requirements in §A of this regulation.</text>
  </paragraph>
</regulation>