<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.19.06" title_num="10" subtitle_num="34" chapter_num="19" heading="Special Handling, Packaging, Labeling, and Beyond Use Dating.">
  <paragraph num="A.">
    <text>The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including:</text>
    <paragraph num="(1)">
      <text>A reasonable effort to provide tamper-evident packaging if appropriate to setting;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Proper in-transit storage consistent with preparation labeling; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Delivery to the patient within a reasonable time.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:</text>
    <paragraph num="(1)">
      <text>The date of preparation unless otherwise readily retrievable from prescription records;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Time prepared, if applicable;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The pertinent requirements for proper storage;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The name of the prescriber, unless in an inpatient hospital setting;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The name of the patient;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Directions for use;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The name of the base solution for infusion preparations;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The name and concentration or amount of active drugs contained in the final sterile preparation;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>The name or identifying initials of the pharmacist who checked or prepared the compounded sterile preparation unless otherwise readily retrievable from prescription records;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>The name, address, and telephone number of the pharmacy unless in an inpatient hospital facility;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>The beyond-use/expiration dating and time of the compounded sterile preparation, and if no time is stated, the time is presumed to be at 11:59 p.m. of the stated beyond use date;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Any ancillary and cautionary instructions as needed; and</text>
    </paragraph>
    <paragraph num="(13)">
      <text>A pertinent warning consistent with applicable federal and State law that cytotoxic preparations are biohazardous, when applicable.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A pharmacy compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP 795 Standards, the pharmacist shall use “beyond-use dating” as determined by USP 797 Standards and reference materials as cited in Regulation .16 of this chapter.</text>
  </paragraph>
</regulation>