<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.32.23.06" title_num="10" subtitle_num="32" chapter_num="23" heading="Requirements for Permit Holders.">
  <paragraph num="A.">
    <text>A permit holder shall comply with all federal and State statutes and regulations regarding prescription drugs, including all requirements for:</text>
    <paragraph num="(1)">
      <text>Dispensing, including labeling;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Storing and securing inventory;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Allowing access only to authorized individuals;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Managing inventory controls;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Recordkeeping; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Submitting prescription monitoring data to the Maryland Prescription Drug Monitoring Program in accordance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A permit holder shall:</text>
    <paragraph num="(1)">
      <text>Perform in person the final check of each drug dispensed;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Sign or initial documentation in person that the final check was completed;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be present on the premises and available for consultation at the time the drug is dispensed;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>With regard to inspections by the OCSA:</text>
      <paragraph num="(a)">
        <text>Personally sign at the time of the inspection the acknowledgement of receipt of the inspection report required by Health Occupations Article, §12-102(c)(2)(ii)4D, Annotated Code of Maryland; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Assure that during all normal office hours a designee is available on the premises who will sign at the time of the inspection the acknowledgement of receipt of the inspection report;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Assure that the lot number of a drug obtained from a stock bottle or other larger container:</text>
      <paragraph num="(a)">
        <text>Is recorded in the office records;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Can be correlated with any patient’s prescription for that drug; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is immediately available for inspection; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Except with regard to sample units, drug samples, and starter dosages in the possession and control of an authorized prescriber, assure that physical access to all prescription drugs is denied to all individuals at all times that a permit holder is not on the premises.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A permit holder may not dispense medications by:</text>
    <paragraph num="(1)">
      <text>Mail order; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A refill.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>For the purposes of this regulation, “refill” means an additional allotment of the same drug initially authorized by the original, written prescription. “Refill” does not prohibit a permit holder from dispensing the same or different drug through an additional or subsequent, written prescription.</text>
  </paragraph>
</regulation>