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<chapter num="35" heading="Limited Dental Drug Dispensing Permits" title_num="10" subtitle_num="44">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <paragraph num="A.">
      <text>This chapter covers the issuance by the State Board of Dental Examiners of a limited dental drug dispensing permit for dentists who wish to dispense only prescription strength:</text>
      <paragraph num="(1)">
        <text>Home fluoride products;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Dentin/enamel remineralizing products; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Antimicrobial rinses.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>This chapter does not apply to a dentist who dispenses prescription drugs in the course of treating a patient at a:</text>
      <paragraph num="(1)">
        <text>Medical facility or clinic that is operated on a nonprofit basis;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Health center that operates on a campus of an institution of higher learning;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Public health facility;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Medical facility under contract with the State or local health department: or</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Facility funded with public funds.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>A dentist who dispenses a full course of antibiotics to a patient for infection control is not required to obtain a drug dispensing permit if the dispensing meets the requirements of Regulation .05A of this chapter.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A dentist who wishes to dispense prescription drugs other than those covered in this chapter is required to obtain a drug dispensing permit as required by COMAR 10.13.01.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Administer” means the direct introduction of a single dosage of a drug at a given time, whether by injection or other means, and whether in liquid, tablet, capsule, or other form.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Board” means the Maryland State Board of Dental Examiners.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Dentist” means an individual who holds a current license to practice dentistry in Maryland.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Limited dental drug dispensing permit” means a drug dispensing permit for dentists who wish to dispense only prescription strength:</text>
        <paragraph num="(a)">
          <text>Home fluoride products;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Dentin/enamel remineralizing products; or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Antimicrobial rinses.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>“Starter dosage” means an amount of a drug sufficient to begin therapy:</text>
        <paragraph num="(a)">
          <text>Of short duration of 72 hours or less; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Before obtaining a large quantity of the drug to complete the therapy.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Permit Required.">
    <text>Subject to the exception contained in Regulation .05 of this chapter, a dentist may not dispense home fluoride products, dentin/remineralizing products or antimicrobial rinses unless the dentist holds a limited drug dispensing permit issued by the Board.</text>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Issuance and Renewal of Permit.">
    <paragraph num="A.">
      <text>A permit expires on October 1 of the 5th year following the effective date of the permit.</text>
    </paragraph>
    <paragraph num="B.">
      <text>To obtain a permit, a dentist shall:</text>
      <paragraph num="(1)">
        <text>Submit to the Board an application on a form provided by the Board; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Pay the fee set by the Board in COMAR 10.44.20.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The Board shall mail a renewal application to each dentist holding a limited dental drug dispensing permit at least 90 days before the expiration of the permit.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Before the permit expires, an applicant may apply to renew the permit for an additional 5-year term if the applicant:</text>
      <paragraph num="(1)">
        <text>Submits to the Board a renewal application on a form provided by the Board; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Pays the renewal fee set by the Board in COMAR 10.44.20.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Exceptions.">
    <paragraph num="A.">
      <text>Drug Samples. A dentist is not required to have a limited dental drug dispensing permit to dispense drug samples if:</text>
      <paragraph num="(1)">
        <text>The sample complies with the labeling requirements contained in Health Occupations Article, §12-505, Annotated Code of Maryland, except that the labeling requirements may not apply if the dentist dispenses the drug:</text>
        <paragraph num="(a)">
          <text>In an emergency situation; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>As a sample dispensed in the regular course of the dentist’s practice;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>No charge is made for the sample; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The dentist enters an appropriate record in the patient’s chart.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Starter Dosages. A dentist is not required to have a limited dental drug dispensing permit to dispense starter dosages if:</text>
      <paragraph num="(1)">
        <text>The starter dosage complies with the labeling requirements contained in Health Occupations Article, §12-505, Annotated Code of Maryland, except that the labeling requirements may not apply if the dentist dispenses the drug:</text>
        <paragraph num="(a)">
          <text>In an emergency situation; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>As a starter dosage dispensed in the regular course of the dentist’s practice;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>No charge is made for the starter dosage; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The dentist enters an appropriate record in the patient’s chart.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Course of Treating a Patient. A dentist is not required to have a limited drug dispensing permit to administer a prescription drug in the course of treating a patient.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Violations.">
    <paragraph num="A.">
      <text>After an opportunity for a hearing, the Board may revoke or suspend a limited permit or take disciplinary action under Health Occupations Article, §4-315(a) or (b), Annotated Code of Maryland, if the Board finds that the holder of the permit violates any provision of this chapter.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Failure to comply with the provisions of this chapter constitutes unprofessional conduct and may constitute other violations of law.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Summary Suspension of a Permit.">
    <paragraph num="A.">
      <text>The Board may order the summary suspension of a permit if the Board:</text>
      <paragraph num="(1)">
        <text>Finds that the public health, safety, or welfare imperatively requires emergency action; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Promptly gives the licensee:</text>
        <paragraph num="(a)">
          <text>Written notice of the suspension, the finding, and the reasons that support the finding; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>An opportunity to be heard.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Service of the notice of the suspension, the finding, the reasons that support the finding, and the notice of the opportunity to be heard may be effected upon the holder of a permit by:</text>
      <paragraph num="(1)">
        <text>Personal service; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Written notice sent by certified mail and regular mail to the permit holder’s address on file with the Board.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Service made pursuant to §B(2) of this regulation shall be effective upon mailing.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The methods of service provided in this regulation are in addition to and not exclusive of any other means of service that are reasonably calculated to provide notice.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health Occupations Article, §4-207(b), Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: July 20, 2015 (42:14 Md. R. 880)</annotation>
  </annotations>
</chapter>