<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.13.04.03" title_num="10" subtitle_num="13" chapter_num="04" heading="Emergency Epinephrine.">
  <paragraph num="A.">
    <text>An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:</text>
    <paragraph num="(1)">
      <text>Is employed by a participating facility;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is 18 years old or older; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:</text>
    <paragraph num="(1)">
      <text>Designation of agents and affiliated individuals;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The name of the approved emergency epinephrine educational training program; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Procedures to:</text>
      <paragraph num="(a)">
        <text>Store emergency use epinephrine;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Maintain the emergency use epinephrine in a secure manner;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Report use of emergency use epinephrine according to §L of this regulation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Train an emergency epinephrine certificate holder and agent annually; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.</text>
  </paragraph>
  <paragraph num="D.">
    <text>An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.</text>
  </paragraph>
  <paragraph num="E.">
    <text>The Department shall:</text>
    <paragraph num="(1)">
      <text>Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency use epinephrine at participating facilities according to §L of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate holder.</text>
  </paragraph>
  <paragraph num="G.">
    <text>A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense emergency use epinephrine under a prescription issued to a certificate holder.</text>
  </paragraph>
  <paragraph num="H.">
    <text>A certificate holder may:</text>
    <paragraph num="(1)">
      <text>On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for emergency use epinephrine; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Possess and store prescribed emergency use epinephrine.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>A participating facility:</text>
    <paragraph num="(1)">
      <text>Shall ensure that there is a written plan for the emergency epinephrine program that:</text>
      <paragraph num="(a)">
        <text>Is approved annually, in writing, by a health supervisor;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is on file at the participating facility and is available for inspection; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Includes at a minimum:</text>
        <paragraph num="(i)">
          <text>The name, title, and license number of the health supervisor;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Information on the emergency epinephrine educational training program used;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Procedures for disseminating information to staff on the emergency epinephrine program;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Procedures for the proper storage and handling of medication;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Procedures for the use of emergency services and 911 services; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Procedures for documenting incidents involving the administration of emergency use epinephrine by a certificate holder in accordance with §L of this regulation;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the participating facility complies with all provisions of this chapter;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Shall provide the Department with access to records and documents required under this chapter;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of emergency use epinephrine;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>May not obtain or store emergency use epinephrine unless the participating facility has at least two certificate holders; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Certificate Holders.</text>
    <paragraph num="(1)">
      <text>Subject to §I(4) of this regulation, a certificate holder may obtain:</text>
      <paragraph num="(a)">
        <text>A prescription for a supply of emergency use epinephrine from a licensed physician as provided in §F of this regulation; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A supply of emergency use epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A certificate holder shall store a supply of emergency use epinephrine obtained under §J(1) of this regulation:</text>
      <paragraph num="(a)">
        <text>In accordance with the manufacturer’s instructions; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In a location that is readily accessible to certificate holders and agents in an emergency situation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.</text>
  </paragraph>
  <paragraph num="L.">
    <text>A participating facility shall ensure that an incident that occurred on the premises of the facility that involved the administration of emergency use epinephrine by a certificate holder or agent is reported:</text>
    <paragraph num="(1)">
      <text>Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To the Department within 5 business days of the incident on a form prescribed by the Department.</text>
    </paragraph>
  </paragraph>
</regulation>