<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.32.04" title_num="10" subtitle_num="34" chapter_num="32" heading="Record Keeping.">
  <paragraph num="A.">
    <text>The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes:</text>
    <paragraph num="(1)">
      <text>The name, address, and date of birth of the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The date of administration and route and site of vaccinations;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The name, dose, manufacturer’s lot number, and expiration date of the vaccine;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The name of the pharmacist, pharmacy student, physician, or nurse administering the vaccination;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The version of the vaccination information statement provided to the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The nature and outcome of an adverse reaction and documentation that the adverse reaction was reported to:</text>
      <paragraph num="(a)">
        <text>The primary care provider; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Vaccine Adverse Event Reporting System.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The records required in this regulation shall be:</text>
    <paragraph num="(1)">
      <text>Readily retrievable;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Made available on the request of the Board;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Except for records related to minor patients, maintained for a minimum of 5 years; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>In the case of a minor patient, maintained until the patient attains the age of majority plus 3 years or for 5 years after the record is made, whichever is later.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The pharmacist administering a vaccination as an independent provider at a location that is not a pharmacy shall maintain the following documentation for a minimum of 5 years:</text>
    <paragraph num="(1)">
      <text>Name, address, and date of birth of the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Date of administration, and route and site of vaccinations;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name, dose, manufacturer's lot number, and expiration date of the vaccine;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Name of the pharmacist or pharmacy student administering the vaccination;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Version of the vaccination information statement provided to the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:</text>
      <paragraph num="(a)">
        <text>The primary care provider; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Vaccine Adverse Event Reporting System.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The pharmacist administering a vaccination on behalf of a permit holder at a location that is not a pharmacy shall maintain the following documentation with the permit holder for a minimum of 5 years:</text>
    <paragraph num="(1)">
      <text>Name, address, and date of birth of the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Date of administration, and route and site of vaccinations;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name, dose, manufacturer's lot number, and expiration date of the vaccine;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Name of the pharmacist or pharmacy student administering the vaccination;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Version of the vaccination information statement provided to the individual receiving the vaccination;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Copy of the signed patient consent form of those individuals to whom the vaccine was administered;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:</text>
      <paragraph num="(a)">
        <text>The primary care provider; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Vaccine Adverse Event Reporting System.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text>
    </paragraph>
  </paragraph>
</regulation>