<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.34.04" title_num="10" subtitle_num="34" chapter_num="34" heading="Validated Pharmacy Technician.">
  <paragraph num="A.">
    <text>Validated Pharmacy Technician — Minimum Requirements.</text>
    <paragraph num="(1)">
      <text>Experience. Prior to working as a validated pharmacy technician, an individual shall have a minimum of 1 year of experience as a registered pharmacy technician in the State.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Training. In addition to the requirements for pharmacy technician registration, to act as a validated pharmacy technician, an individual shall possess an active product verification certificate issued by a Board-approved national pharmacy technician certification program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Validated Pharmacy Technician — Final Product Verification. A pharmacist may delegate responsibility to perform the final verification of a prescription device, drug product, or medication order to a validated pharmacy technician under the following circumstances:</text>
    <paragraph num="(1)">
      <text>Prescription or Medication Order.</text>
      <paragraph num="(a)">
        <text>A pharmacist shall verify the data entry of the prescription device, drug product, or medication order in the pharmacy management system or, if applicable, the electronic health record for:</text>
        <paragraph num="(i)">
          <text>Accuracy;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Appropriateness of the device, drug product, or medication;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Appropriateness of the dosage form;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Directions for use;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Labeling;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Packaging; and</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Any other determination that requires the application of clinical expertise.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Bar code scanning or similar technology is utilized during the filling process and at the verification step to validate device, drug product, or medication selection accuracy.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The product being verified is packaged in unit-dose or unit-of-use packaging.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Stocking or Replenishing a Medication Distribution System. Notwithstanding any other regulation, a validated pharmacy technician may perform the final product verification of a prescription device, drug product, or medication selected for stocking into a medication distribution system provided that:</text>
      <paragraph num="(a)">
        <text>The medication distribution system utilizes bar code scanning or other similar technology to validate the device, drug product, or medication selection; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The pharmacy responsible for the medication distribution system maintains and reviews annually a quality assurance policy which includes routine audits of the system to ensure the accuracy of stocked prescriptions.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A validated pharmacy technician may not perform the final product verification of a prescription device, drug product, or medication that the technician personally prepared.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Validated Pharmacy Technician — Pharmacy Permit Holder’s Responsibilities. A pharmacy utilizing a validated pharmacy technician shall maintain records for a minimum of 2 years, and have those records readily available to the Board upon request, including:</text>
    <paragraph num="(1)">
      <text>A current list of all validated pharmacy technicians;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A job description for each validated pharmacy technician; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Policies and standard operating procedures for validated pharmacy technicians.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Validated Pharmacy Technician – Pharmacist’s Responsibilities.</text>
    <paragraph num="(1)">
      <text>A pharmacist may not delegate the final product verification of a compounded medication under any circumstance.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Notwithstanding any delegation of a pharmacy act to a validated pharmacy technician, a pharmacist shall maintain professional responsibility for every medication or prescription dispensed, and for each medication or prescription stocked into a medication distribution system under the supervision of the pharmacist.</text>
    </paragraph>
  </paragraph>
</regulation>