<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05" citation="COMAR 10.34.33.05" title_num="10" subtitle_num="34" chapter_num="33" heading="Donation Program — Drop-Off Sites Requirements.">
  <paragraph num="A.">
    <text>In order to become a drop-off site, a pharmacy or other health care facility:</text>
    <paragraph num="(1)">
      <text>Shall submit an application to the Board to be designated as a voluntary drop-off site;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall be in good standing with the Board or the Office of Health Care Quality;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>May not have a final disciplinary order issued against it by a health occupations board;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>May not be owned or operated by a health care practitioner who has not fulfilled the requirements of a final disciplinary order that may have been issued against the owner or operator by a health occupations boards;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Shall maintain records of donated prescription drugs or medical supplies; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Shall assign a pharmacist or other health care practitioner the responsibility to accept donated prescription drugs or medical supplies at the drop-off site.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Assigned Pharmacist or Other Health Care Practitioner's Responsibility. A pharmacist or health care practitioner accepting donated prescription drugs or medical supplies at a drop-off site as set forth in §A(6) of this regulation:</text>
    <paragraph num="(1)">
      <text>May not delegate acceptance of donated prescription drugs or medical supplies;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>May refuse to accept hazardous prescription drugs or medical supplies for donation if the decision is based on professional judgment, experience, knowledge, or available reference materials;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Shall be in good standing with the pharmacist's or health care practitioner's respective health occupations board; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Shall have fulfilled the requirements of a final disciplinary order that may have been issued against the pharmacist or health care practitioner by a health occupations board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Record Requirements. A drop-off site shall:</text>
    <paragraph num="(1)">
      <text>Obtain a signed donor form releasing the prescription drug or medical supplies to the Program;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide a copy of the signed donor form to the donor; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Maintain records of signed donor forms for 5 years.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Procedures for Handling of Donated Prescription Drugs or Medical Supplies.</text>
    <paragraph num="(1)">
      <text>A drop-off site shall:</text>
      <paragraph num="(a)">
        <text>Place the donated prescription drug or medical supply and the donor form in a sealed bag;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Store the bag containing the donated prescription drugs or medical supplies in an area accessible only to those pharmacists or health care practitioners who have been assigned the responsibility to accept the donated prescription drugs or medical supplies; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Forward the sealed bags of donated prescription drugs or medical supplies to the repository at least every 2 weeks.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A drop-off site may not:</text>
      <paragraph num="(a)">
        <text>Dispense donated prescription drugs or medical supplies;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Resell prescription drugs or medical supplies donated to the Program;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Charge a fee for accepting a donation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Accept donated prescription drugs or medical supplies until the drop-off site applicant has been approved by the Board; or</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Accept prescription drugs for disposal.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>