<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06-1" citation="COMAR 10.34.33.06-1" title_num="10" subtitle_num="34" chapter_num="33" heading="Repositories Participating in the Donation Program.">
  <paragraph num="A.">
    <text>Designated Pharmacist. A repository in the donation program shall designate a pharmacist who shall:</text>
    <paragraph num="(1)">
      <text>Accept donated prescription drugs or medical supplies forwarded by:</text>
      <paragraph num="(a)">
        <text>A drop-off site; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A manufacturer regulated by the U.S. Food and Drug Administration;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Inspect donated prescription drugs or medical supplies;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Accept donated prescription drugs or medical supplies that meet the requirements of Regulations .02 and .03 of this chapter; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Obliterate from the labels of donated prescription drugs or medical supplies patient specific information for which the donated prescription drugs or medical supplies were originally dispensed when it is placed in inventory.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Record Requirements. A repository in the Donation Program shall:</text>
    <paragraph num="(1)">
      <text>Maintain a separate inventory of donated prescription drugs or medical supplies for a minimum of 5 years;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain separate prescription files for patients receiving donated prescription drugs or medical supplies for a minimum of 5 years; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Submit an annual report on its activities to the Board that includes at least information on the:</text>
      <paragraph num="(a)">
        <text>Number of recipients by county;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Approximate market value of the prescription drugs or medical supplies dispensed;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>50 prescription drugs or medical supplies most frequently dispensed; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Total number of donations to the Program.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Procedures for Handling of Donated Prescription Drugs or Medical Supplies.</text>
    <paragraph num="(1)">
      <text>A repository in the Donation Program shall store donated prescription drugs or medical supplies in a secure location separate from other inventory in accordance with State and federal laws and regulations.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A repository may not:</text>
      <paragraph num="(a)">
        <text>Resell prescription drugs or medical supplies donated to the Program; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Establish or maintain a waiting list for prescription drugs or medical supplies dispensed by the Program.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A repository may charge a fee of not more than $10 for each prescription drug or medical supply dispensed under the Program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Limitations. A repository in the Donation Program is under no obligation to obtain a prescription drug or medical supply that is not in inventory at the time of the request.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Procedure for Dispensing Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall dispense donated prescription drugs or medical supplies in compliance with applicable federal and State laws and regulations for dispensing prescription drugs or medical supplies.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Procedure for Shipping Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall comply with COMAR 10.34.25 when shipping donated prescription drugs or medical supplies to recipients of this Program.</text>
  </paragraph>
  <paragraph num="G.">
    <text>Procedures for Disposing of Donated Prescription Drugs or Medical Supplies.</text>
    <paragraph num="(1)">
      <text>A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies that do not meet the eligibility requirements of Regulation .02 of this chapter.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies in compliance with applicable State and federal laws and regulations for disposing of prescription drugs or medical supplies.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A repository shall maintain records of disposal of donated prescription drugs or medical supplies.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Determination of Patient Eligibility for the Donation Program.</text>
    <paragraph num="(1)">
      <text>A recipient of the Donation Program shall be a resident of the State.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A health care practitioner with prescribing authority shall:</text>
      <paragraph num="(a)">
        <text>Determine, at the health care practitioner’s discretion, the financial need of a patient to participate in the Donation Program; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Indicate on the patient’s prescription eligibility for the Donation Program.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Recipient Form. Recipients of a donated prescription drug or medical supply under the Donation Program shall sign a Board approved form before receiving the prescription drug or medical supply to confirm that the recipient understands that:</text>
    <paragraph num="(1)">
      <text>The recipient is receiving prescription drugs or medical supplies that have been donated as part of the Donation Program; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Entities involved in the Donation Program have immunity from liability in accordance with Health-General Article, §15-607, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
</regulation>