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<chapter num="25" heading="Delivery of Prescriptions" title_num="10" subtitle_num="34">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter governs the manner in which a Maryland licensed pharmacy delivers filled prescriptions for individual patients by United States Postal Service, common carrier, or delivery service to an address within the State.</text>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meaning indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Delivery” means to send a prescription medication from a pharmacy by the United States Postal Service, common carrier, or delivery system to an address within the State.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Depot.</text>
        <paragraph num="(a)">
          <text>“Depot” means a location where filled prescriptions are stored before delivery to the intended patient or the intended patient's authorized agent.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Depot” does not include:</text>
          <paragraph num="(i)">
            <text>A licensed health care facility;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A prescriber's office;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>The prescription area of a pharmacy as defined by COMAR 10.34.05.01;</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>The United States Postal Service or common carrier's warehouse; or</text>
          </paragraph>
          <paragraph num="(v)">
            <text>A multiple family residence.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>“Patient” means the individual or companion animal for whom a prescription is written and to whom a prescription medication will be administered.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Patient profile” means a record of dispensing activity maintained by a pharmacist for a specific patient.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Residence” means the street address at which a patient resides.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Storage” means the maintenance of a supply of medication before receipt of the medication by the patient or an agent authorized by the patient.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Requirements for Packaging and Delivery of Prescription Medication.">
    <paragraph num="A.">
      <text>Packaging. Prescription medications delivered under this chapter to individuals in the State shall be:</text>
      <paragraph num="(1)">
        <text>Enclosed in a container that reveals to the patient any tampering of the container that occurred during delivery or storage;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Packaged in a shipping container in a manner that does not indicate that the contents are medications;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Packaged in a manner that indicates:</text>
        <paragraph num="(a)">
          <text>The name and address of the patient or authorized agent; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Any special storage conditions or requirements; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>Packaged to contain:</text>
        <paragraph num="(a)">
          <text>Written information regarding the prescription drug or device which is considered significant in the professional judgment of the pharmacist;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A local or toll-free telephone number for the pharmacy; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Notification to the patient if the appearance of the patient’s medication has changed from the patient’s last refill.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Delivery.</text>
      <paragraph num="(1)">
        <text>Location.</text>
        <paragraph num="(a)">
          <text>A prescription medication may be delivered to the patient for whom the prescription is prescribed, wherever the patient is located.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Instead of delivering medication directly to the patient under §B(1)(a) of this regulation, medication may be delivered to:</text>
          <paragraph num="(i)">
            <text>An agent authorized by the patient; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>The residence of the patient, regardless of whether the patient is present at the residence at the time of delivery.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>The pharmacy permit holder shall:</text>
        <paragraph num="(a)">
          <text>Enclose information to inform the patient if the patient’s prescription is a temperature sensitive medication that is at risk for damage due to extreme hot or cold temperatures or moisture:</text>
          <paragraph num="(i)">
            <text>During shipment; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>After delivery to the patient’s mailbox or other designated location; and</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>Inform the patient within 24 hours of being notified of the delay if the scheduled delivery of the patient’s prescription will be interrupted or late.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Depots.">
    <text>A pharmacy may not knowingly deliver prescription medications to a depot, or establish or cooperate in the establishment of a depot.</text>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Record Keeping.">
    <paragraph num="A.">
      <text>If a patient authorizes delivery of prescription medication to an agent at a location other than the pharmacy, or the patient's residence, the pharmacist shall document the authorization:</text>
      <paragraph num="(1)">
        <text>On the prescription;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>In the patient profile; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>In another record maintained in the pharmacy and established for this purpose.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>If prescription medication is sent to an agent authorized by the patient at a location other than the patient's residence, or the place of business of the patient's authorized prescriber, the pharmacy shall maintain a record of the:</text>
      <paragraph num="(1)">
        <text>Identity of the agent to whom the medication is sent;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Location where the medication is sent;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Date and time the medication is sent; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Prescription number or description of the medication sent.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: December 10, 2001 (28:24 Md. R. 2128)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 1, 2012 (39:1 Md. R. 17)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02B amended effective March 1, 2012 (39:1 Md. R. 17)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective March 1, 2012 (39:1 Md. R. 17)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 repealed effective March 1, 2012 (39:1 Md. R. 17)</annotation>
  </annotations>
</chapter>