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<regulation prefix="Regulation" num=".02" citation="COMAR 10.34.03.02" title_num="10" subtitle_num="34" chapter_num="03" 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>“Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is:</text>
      <paragraph num="(a)">
        <text>Dependent on another institutional pharmacy for:</text>
        <paragraph num="(i)">
          <text>Administrative control;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Staffing with a licensed pharmacist physically available on site in the decentralized pharmacy to supervise the performance of delegated pharmacy acts; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Drug procurement; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Located in the same building or pavilion as the other institutional pharmacy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(1-1)">
      <text>“Direct supervision” means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts.</text>
    </paragraph>
    <paragraph num="(1-2)">
      <text>“Director of pharmacy” means a pharmacist who is responsible for the pharmacy services provided by an institutional pharmacy in compliance with appropriate State and federal laws and regulations.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Dispense” or “dispensing” means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agent and which entails the:</text>
      <paragraph num="(a)">
        <text>Interpretation of an authorized prescriber’s prescription for a drug or device;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Selection and labeling of the drug or device prescribed pursuant to that prescription; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Measuring and packaging of the prescribed drug or device in accordance with State and federal laws.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Distribute.</text>
      <paragraph num="(a)">
        <text>“Distribute” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Title 12, Annotated Code of Maryland, prior to administration of the provided drug or device to the patient pursuant to a prescription issued by an authorized prescriber.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Distribute” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12–6C–03, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>“Drug” means a prescription or non-prescription medication or other material used in the diagnosis or treatment of injury, illness, or disease.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Drug recall” means the recall of a drug by a manufacturer or the U.S. Food and Drug Administration (FDA) in the event that there is a reasonable possibility that the use of or exposure to an affected product may cause either:</text>
      <paragraph num="(a)">
        <text>Adverse effects on health; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Death.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>“Emergency drug supply” means a process for supplying drugs which:</text>
      <paragraph num="(a)">
        <text>May be required for the emergency need of a patient; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is not available from an authorized source in a timely manner.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>“Institutional facility” or “institution” means an entity other than a comprehensive care facility, assisted living facility, developmental disabilities facility, or correctional facility whose primary purpose is to provide a physical environment for patients to obtain inpatient, outpatient, or emergency care, except for urgent care facilities that are not part of an institution.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Institutional medication protocol” means a course of therapy including drug treatment predetermined and documented by the institution and the generally accepted medical practice for proper completion of a particular therapeutic or diagnostic intervention ordered by an authorized prescriber and which allows the pharmacist to execute the protocol.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Institutional pharmacy” means a pharmacy which:</text>
      <paragraph num="(a)">
        <text>Provides services to an acute care, rehabilitation, transitional care, chronic care, or mental health hospital;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Engages in compounding, distributing, or dispensing of drugs;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>May provide nondispensing functions as described in Regulation .16 of this chapter; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Has been issued a pharmacy permit pursuant to Health Occupations Article, §§12-401 and 12-403(c), Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>“Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Medication order” means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber’s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the:</text>
      <paragraph num="(a)">
        <text>Date ordered;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Drug name;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dosage;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Dosage form;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Patient name with second identifier such as date of birth or medical record number;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Route of administration;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Administration instructions, if appropriate; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Signature, if appropriate, of an:</text>
        <paragraph num="(i)">
          <text>Authorized prescriber, as defined in Health Occupations Article, §12-101(b), Annotated Code of Maryland; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Individual permitted to practice medicine without a license as defined in Health Occupations Article, §14-302, Annotated Code of Maryland.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(12)">
      <text>“Order-sets” means predefined orders, including medication orders, that are based on an institutionally approved protocol.</text>
    </paragraph>
    <paragraph num="(12-1)">
      <text>“Pavilion” means a detached or semidetached part of a hospital devoted to a special use.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Pharmaceutical care.</text>
      <paragraph num="(a)">
        <text>“Pharmaceutical care” means the provision of a patient’s drug regimen for the purpose of:</text>
        <paragraph num="(i)">
          <text>Achieving definite outcomes related to the cure or prevention of a disease;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Elimination or reduction of a patient’s symptoms; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Arresting or slowing of a disease process by identifying, resolving, or preventing actual or potential drug therapy problems.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Pharmaceutical care” may include patient counseling and providing information to licensed and certified health care providers.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(14)">
      <text>“Prescription Drug.</text>
      <paragraph num="(a)">
        <text>“Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Prescription drug” includes:</text>
        <paragraph num="(i)">
          <text>A biological product; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug and Cosmetic Act.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>“Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(15)">
      <text>“Second identifier” means a reliable method to:</text>
      <paragraph num="(a)">
        <text>Identify a patient for whom service or treatment is intended; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Match the service or treatment intended to the patient.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(16)">
      <text>“Verbal order” means a medication order from an authorized prescriber which is received by an authorized licensed practitioner using appropriate read back procedures that is subsequently recorded in the patient’s chart and countersigned by the prescriber within a time period required by the institution.</text>
    </paragraph>
    <paragraph num="(17)">
      <text>“Written order” means a medication order that is recorded as a written document by an authorized prescriber.</text>
    </paragraph>
  </paragraph>
</regulation>