<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.37.04" title_num="10" subtitle_num="34" chapter_num="37" heading="Requirements for Nonresident Pharmacy Operations.">
  <paragraph num="A.">
    <text>A Maryland licensed pharmacist may not be employed by more than one nonresident pharmacy at a time.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A nonresident pharmacy shall:</text>
    <paragraph num="(1)">
      <text>Hold a pharmacy permit issued by the Board;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Have a pharmacist on staff who is:</text>
      <paragraph num="(a)">
        <text>Licensed by the Board;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Designated as the pharmacist responsible for providing pharmaceutical services to patients in the State; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Regularly available on-site as needed to meet Maryland patient’s needs;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Designate another Maryland licensed pharmacist as the pharmacist on staff within 60 days upon the loss of the current designated pharmacist on staff;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Be located and equipped so that the pharmacy may be operated without endangering the public health or safety;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Maintain at all times a current reference library that is appropriate to meet the needs of:</text>
      <paragraph num="(a)">
        <text>The practice specialty of that pharmacy; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The consumers the pharmacy serves;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Comply with the regulations adopted by the Board establishing the types of texts required to be included in the reference libraries in each of the various practice specialty pharmacies;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary in a pharmacy to:</text>
      <paragraph num="(a)">
        <text>Prepare and dispense prescriptions properly; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Otherwise operate a pharmacy;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>Be equipped with the minimum equipment and appliances specified by the Board under this regulation;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Be kept in a clean and orderly manner;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Store all prescription or nonprescription drugs or devices properly and safely as set forth in COMAR 10.34.22.06;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>On an annual basis and within 30 days after a change of office, corporate officer, or pharmacist, disclose to the Board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices to persons in this State;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is located and all requests for information made by the Board pursuant to this regulation;</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Maintain at all times a valid, unexpired permit to conduct a pharmacy in compliance with the laws of the state in which it is located;</text>
    </paragraph>
    <paragraph num="(14)">
      <text>Maintain records of prescription drugs or devices dispensed to patients in this State so that the records are readily retrievable;</text>
    </paragraph>
    <paragraph num="(15)">
      <text>During the pharmacy’s regular hours of operation, but not less than 6 days a week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist or an individual who:</text>
      <paragraph num="(a)">
        <text>Has access to the patient’s prescription records; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is required to refer patients in the State to the responsible pharmacist licensed in the State, as appropriate;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(16)">
      <text>Disclose the pharmacy’s toll-free telephone number on a label affixed to each container of drugs or devices;</text>
    </paragraph>
    <paragraph num="(17)">
      <text>Comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the nonresident pharmacy is located;</text>
    </paragraph>
    <paragraph num="(18)">
      <text>With regard to a prescription drug that is delivered in this State by the United States Postal Service, a common carrier, or a delivery service and is not personally hand delivered directly to a patient or to the agent of the patient at the residence of the patient or at another location designated by the patient:</text>
      <paragraph num="(a)">
        <text>Provide a general written notice in each shipment of a prescription drug that alerts a consumer that, under certain circumstances, a medication’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Provide a specific written notice in each shipment of a prescription drug that provides a consumer with a toll-free or local consumer access telephone number accessible during regular hours of operation, which is designed to respond to consumer questions pertaining to medications;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(19)">
      <text>Provide information regarding the process for resolving incorrectly filled prescriptions in accordance with existing regulations by:</text>
      <paragraph num="(a)">
        <text>Posting a sign that is conspicuously positioned and readable by consumers at the point where prescription drugs are dispensed to consumers; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Including written information regarding the process with each prescription dispensed; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(20)">
      <text>If dispensing compounded sterile preparations to patients in the State, comply with:</text>
      <paragraph num="(a)">
        <text>USP standards; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>COMAR 10.34.19.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A nonresident pharmacy may not:</text>
    <paragraph num="(1)">
      <text>Offer pharmaceutical services under any term or condition that tends to interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Make any agreement that denies a patient a free choice of pharmacist or pharmacy services;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Participate in any activity that is a ground for Board action against:</text>
      <paragraph num="(a)">
        <text>A licensed pharmacist under Health Occupations Article, §12–313, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A registered pharmacy technician under Health Occupations Article, §12–6B–09, Annotated Code of Maryland; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A registered pharmacy intern under Health Occupations Article, §12–6D–11, Annotated Code of Maryland; or</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Allow an unauthorized individual to represent that the individual is a pharmacist, a registered pharmacy intern, or registered pharmacy technician.</text>
    </paragraph>
  </paragraph>
</regulation>