Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.03 - Minimum Application Requirements for Applicants Holding Product

Current through Register Vol. 51, No. 14, July 12, 2024
A. 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:
(1) The type of business form under which the
				  applicant operates, such as partnership, corporation, or sole
				  proprietorship;
(2) The full name
				  or names of the owner and the operator of the wholesale distributor applying
				  for or renewing a permit, including:
(a) For
				  an individual, the:
(i) Full name of the
				  individual;
(ii) Telephone number
				  of the individual;
(iii) Business
				  address of the individual; and
(iv)
				  Date of birth of the individual;
(b) For a partnership, the:
(i) Full name of each partner;
(ii) Telephone number of the
				  partnership;
(iii) Address of each
				  partner;
(iv) Date of birth of each
				  partner;
(v) Business address of
				  the partnership; and
(vi) Federal
				  employer identification number of the partnership;
(c) For a publicly traded corporation, the:
(i) Full name and title of each corporate
				  officer and director;
(ii)
				  Telephone number of the publicly traded corporation;
(iii) Business address of the
				  corporation;
(iv) Federal employer
				  identification number of the corporation;
(v) Name of parent company or companies if
				  applicable;
(vi) Corporate
				  names;
(vii) Name of the state of
				  incorporation; and
(viii) Name and
				  address of the resident agent of the corporation;
(d) For a nonpublicly traded corporation,
				  the:
(i) Full name and title of each corporate
				  officer and director;
(ii) The
				  telephone number of the nonpublicly traded corporation;
(iii) Business address of the
				  corporation;
(iv) Federal employer
				  identification number of the corporation;
(v) Name of parent company or companies if
				  applicable;
(vi) Corporate
				  names;
(vii) 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;
(viii) Name of the state
				  of incorporation; and
(ix) Name and
				  address of the resident agent of the corporation;
(e) For a sole proprietorship, the:
(i) Full name of the sole
				  proprietor;
(ii) The telephone
				  number of the sole proprietor;
(iii) Full name of the business
				  entity;
(iv) Business address;
				  and
(v) Date of birth of the sole
				  proprietor;
(f) For a
				  limited liability company, the:
(i) Full name
				  and business address of the limited liability company;
(ii) Telephone number of the limited
				  liability company;
(iii) Full name
				  of each member;
(iv) Full name of
				  each manager;
(v) Federal employer
				  identification number of the limited liability company;
(vi) Name of the state in which the limited
				  liability company was organized; and
(vii) Name and address of the resident agent
				  of the company;
(3) 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;
(4) 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;
(5) 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;
(6) 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;
(7) For the designated representative and the
				  immediate supervisor of the designated representative at the applicant's place
				  of business the following information:
(a)
				  Names;
(b) Places of residence for
				  the past 7 years;
(c) Dates and
				  places of birth;
(d) 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;
(e) 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;
(f) 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;
(g) 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;
(h) 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;
(i) 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
(j) A
				  photograph of the individual taken in the previous 180 days;
(8) A full description of the
				  facility and warehouse including:
(a) Square
				  footage;
(b) Security and alarm
				  system descriptions;
(c) Terms of
				  lease or ownership;
(d) Address;
				  and
(e) Description of temperature
				  and humidity controls;
(9) Written evidence that the wholesale
				  distributor has obtained general and product liability insurance;
(10) A description of the wholesale
				  distributor's import and export activities; and
(11) Other relevant information that the
				  Board may require.