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<regulation prefix="Regulation" num=".02" citation="COMAR 10.34.34.02" title_num="10" subtitle_num="34" chapter_num="34" 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>Compounding.</text>
      <paragraph num="(a)">
        <text>“Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:</text>
        <paragraph num="(i)">
          <text>As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Delegated Pharmacy Act.</text>
      <paragraph num="(a)">
        <text>“Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Delegated pharmacy act” does not include:</text>
        <paragraph num="(i)">
          <text>An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>“Direct supervision” means that a licensed pharmacist is physically available onsite to supervise the performance of delegated pharmacy acts.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Experiential learning rotation” means a course offered by an Accreditation Council for Pharmacy Education accredited school of pharmacy that is designed to provide pharmacy practice experiences to students seeking the doctor of pharmacy degree.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Final Product Verification.</text>
      <paragraph num="(a)">
        <text>“Final product verification” means:</text>
        <paragraph num="(i)">
          <text>Confirming the accuracy of the device or drug product, and dosage form of a filled prescription or medication order; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Confirming the accuracy of the device or drug product, and dosage form of a prescription or medication selected for stocking into a medication distribution system.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Final product verification” does not include determining the appropriateness of the prescription device or drug product, dosage form, directions for use, labeling, packaging, or any other determination that requires the application of a pharmacist’s clinical expertise.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>“Medication distribution system” means an automated medication system, emergency box, interim box, medication carousel or cart, or other storage and dispensing system.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“National pharmacy technician certification program” means a program approved by a Board-recognized national accrediting body.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Pharmacy technician trainee” means an individual engaged in a Board-approved pharmacy technician training program.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>“Registration” means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.</text>
    </paragraph>
    <paragraph num="(14)">
      <text>“Unit dose” means a package labeled with bar code scanning or other similar technology containing a single dose of a device, drug, or medication ordered or prescribed for a patient.</text>
    </paragraph>
    <paragraph num="(15)">
      <text>“Unit-of-use” means a package or container, such as a unit dose (injectable, liquid, or solid), otic, ophthalmic product, otic product, topical product, or a prescription vial filled from a stock bottle or in the original manufacturer’s packaging, designed to be dispensed to a patient that is labeled with bar code scanning or other similar technology.</text>
    </paragraph>
    <paragraph num="(16)">
      <text>“Validated pharmacy technician” means a registered pharmacy technician who has obtained a product verification certificate issued by a Board-approved national training program and satisfied other regulatory requirements.</text>
    </paragraph>
  </paragraph>
</regulation>