<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.34.35.02" title_num="10" subtitle_num="34" chapter_num="35" heading="Permit Holder Responsibilities.">
  <text>The permit holder shall:</text>
  <paragraph num="A.">
    <text>Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Ensure that an annual review of the policy and procedure manual is performed by a qualified clinician or clinicians to assure that the policies and procedures meet the current standards of practice and regulatory requirements;</text>
  </paragraph>
  <paragraph num="C.">
    <text>Ensure that there is a process to verify the name, address, and contact information of the licensed authorized prescriber of record before initiation of therapy;</text>
  </paragraph>
  <paragraph num="D.">
    <text>Establish and maintain a training program which includes, but is not limited to, the requirements set forth in Regulation .07 of this chapter;</text>
  </paragraph>
  <paragraph num="E.">
    <text>If the infusion pharmacy is performing sterile compounding, ensure compliance with COMAR 10.34.19;</text>
  </paragraph>
  <paragraph num="F.">
    <text>If the infusion pharmacy outsources sterile compounding to another pharmacy, confirm that the secondary pharmacy is appropriately licensed and in compliance with COMAR 10.34.04 and COMAR 10.34.19;</text>
  </paragraph>
  <paragraph num="G.">
    <text>Assign a supervising pharmacist to provide oversight of the facility and operations as specified in Regulation .03 of this chapter;</text>
  </paragraph>
  <paragraph num="H.">
    <text>Ensure adequate supervision to unlicensed personnel;</text>
  </paragraph>
  <paragraph num="I.">
    <text>Limit access to the infusion pharmacy area to authorized personnel;</text>
  </paragraph>
  <paragraph num="J.">
    <text>Secure the facility and patient records in compliance with federal and State laws and regulations; and</text>
  </paragraph>
  <paragraph num="K.">
    <text>Develop and implement a written performance improvement program as set forth in Regulation .08 of this chapter.</text>
  </paragraph>
</regulation>