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<regulation prefix="Regulation" num=".03" citation="COMAR 10.34.22.03" title_num="10" subtitle_num="34" chapter_num="22" heading="Minimum Application Requirements for Applicants Holding Product.">
  <paragraph num="A.">
    <text>The Board shall require the following minimum information from a wholesale distributor as part of an application for a permit and as part of a renewal of a permit:</text>
    <paragraph num="(1)">
      <text>The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The full name or names of the owner and the operator of the wholesale distributor applying for or renewing a permit, including:</text>
      <paragraph num="(a)">
        <text>For an individual, the:</text>
        <paragraph num="(i)">
          <text>Full name of the individual;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Telephone number of the individual;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Business address of the individual; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Date of birth of the individual;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>For a partnership, the:</text>
        <paragraph num="(i)">
          <text>Full name of each partner;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Telephone number of the partnership;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Address of each partner;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Date of birth of each partner;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Business address of the partnership; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Federal employer identification number of the partnership;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>For a publicly traded corporation, the:</text>
        <paragraph num="(i)">
          <text>Full name and title of each corporate officer and director;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Telephone number of the publicly traded corporation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Business address of the corporation;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Federal employer identification number of the corporation;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Name of parent company or companies if applicable;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Corporate names;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Name of the state of incorporation; and</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Name and address of the resident agent of the corporation;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>For a nonpublicly traded corporation, the:</text>
        <paragraph num="(i)">
          <text>Full name and title of each corporate officer and director;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The telephone number of the nonpublicly traded corporation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Business address of the corporation;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Federal employer identification number of the corporation;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Name of parent company or companies if applicable;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Corporate names;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Full name and business address of shareholders of more than 10 percent of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange;</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Name of the state of incorporation; and</text>
        </paragraph>
        <paragraph num="(ix)">
          <text>Name and address of the resident agent of the corporation;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>For a sole proprietorship, the:</text>
        <paragraph num="(i)">
          <text>Full name of the sole proprietor;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The telephone number of the sole proprietor;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Full name of the business entity;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Business address; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Date of birth of the sole proprietor;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>For a limited liability company, the:</text>
        <paragraph num="(i)">
          <text>Full name and business address of the limited liability company;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Telephone number of the limited liability company;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Full name of each member;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Full name of each manager;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Federal employer identification number of the limited liability company;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Name of the state in which the limited liability company was organized; and</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Name and address of the resident agent of the company;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>All trade or business names used by the permit holder which may not be identical to the name used by another unrelated applicant in the State;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A list of federal and state licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by federal authority or another state that authorizes the wholesale distributor to purchase, possess, and distribute prescription drugs or devices;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>A list of disciplinary actions by federal or state agencies against the wholesale distributor as well as any such actions against principals, owners, directors, or officers;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>For the designated representative and the immediate supervisor of the designated representative at the applicant's place of business the following information:</text>
      <paragraph num="(a)">
        <text>Names;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Places of residence for the past 7 years;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dates and places of birth;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The name and address of each business where the individual was employed during the past 7 years, and the individual's job title or office held at each business;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years, with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of the guilt was withheld or whether the individual pled guilty or nolo contendere;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and</text>
      </paragraph>
      <paragraph num="(j)">
        <text>A photograph of the individual taken in the previous 180 days;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>A full description of the facility and warehouse including:</text>
      <paragraph num="(a)">
        <text>Square footage;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Security and alarm system descriptions;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Terms of lease or ownership;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Address; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Description of temperature and humidity controls;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>Written evidence that the wholesale distributor has obtained general and product liability insurance;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>A description of the wholesale distributor's import and export activities; and</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Other relevant information that the Board may require.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Criminal Background Check Requirements for an Applicant Located in this State. The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to the Central Repository and the Federal Bureau of Investigation:</text>
    <paragraph num="(1)">
      <text>Electronically or digitally captured fingerprints at approved electronic fingerprint locations approved by the Director of the Central Repository;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The fee authorized under the Criminal Procedure Article, §10-221(b)(7), Annotated Code of Maryland, for access to State criminal history records; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B-1.">
    <text>Criminal Background Check Requirements for an Applicant Located Outside this State.</text>
    <paragraph num="(1)">
      <text>The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to a criminal history records check by the applicant’s state of residence, in accordance with the laws of the applicant’s state of residence.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The criminal history records check shall consist of:</text>
      <paragraph num="(a)">
        <text>A state criminal history records check for the applicant’s state of residence; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A national criminal history records check.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant’s state of residence to forward the results of the criminal history records check to the Board and the applicant.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>If the appropriate entity in the applicant’s state of residence is unable to forward the results of the criminal history records check, then the designated representative and the immediate supervisor of the designated representative of an applicant shall ensure that the results of the criminal history records check are forwarded to the Board in a manner approved by the Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The information required under §A of this regulation shall be provided under oath.</text>
  </paragraph>
  <paragraph num="D.">
    <text>The Board may not issue an initial or renewal wholesale distributor permit to an applicant unless the Board or its designee:</text>
    <paragraph num="(1)">
      <text>If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant's place of business, including any facility of the applicant;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Finds that the place of business and facility, if any, meets the Board's requirements;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Determines that the designated representative of the applicant meets the following qualifications:</text>
      <paragraph num="(a)">
        <text>Is 21 years old or older;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is employed by the applicant full time in a managerial level position;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Is actively involved in, and aware of, the daily operation of the wholesale distributor;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in §1504 of the Internal Revenue Code;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Does not have any convictions for a felony under federal, State, or local laws; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications:</text>
      <paragraph num="(a)">
        <text>Is 21 years old or older;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is employed by the applicant full time in a managerial level position;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Is actively involved in, and aware of, the daily operation of the wholesale distributor;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution, or distribution of controlled substances; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Does not have any convictions for a felony under federal, state, or local laws.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Surety Bond.</text>
    <paragraph num="(1)">
      <text>An applicant for a wholesale distributor permit shall submit a surety bond or other equivalent means of security acceptable to the State such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the State Board of Pharmacy to be deposited into an account established by the State under Health Occupations Article, §12-6C-05(f)(7), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The surety bond, or other security, shall be in the amount of:</text>
      <paragraph num="(a)">
        <text>$100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>$50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>An applicant shall submit the following documentation to verify the applicant's annual gross receipts in the State are less than $10,000,000 for the previous tax year:</text>
      <paragraph num="(a)">
        <text>A federal tax return; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An annual sales report specifying the sales of prescription drugs and devices in the State audited by a certified public accountant.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A surety bond is not required for a pharmacy warehouse that is not engaged in wholesale distribution.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>An applicant shall obtain a surety bond for each facility.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>A single surety bond may cover all facilities operated by the applicant within this State.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility.</text>
  </paragraph>
  <paragraph num="G.">
    <text>The Board shall notify the applicant of the Board's acceptance or rejection of the application within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks.</text>
  </paragraph>
  <paragraph num="H.">
    <text>The applicant shall pay to the Board an application fee set forth in COMAR 10.34.09.02.</text>
  </paragraph>
  <paragraph num="I.">
    <text>The wholesale distributor shall provide changes in information provided pursuant to Regulation .03 of this chapter to the Board within 30 days of the effective date of the change.</text>
  </paragraph>
  <paragraph num="J.">
    <text>Information and qualification requirements for obtaining a permit under this regulation, beyond that required by federal law, does not apply to a manufacturer who distributes its own prescription:</text>
    <paragraph num="(1)">
      <text>Drugs approved by the U.S. Food and Drug Administration; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Devices that are approved or authorized by the U.S. Food and Drug Administration.</text>
    </paragraph>
  </paragraph>
</regulation>