Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 35 - LICENSURE OF EXTENDED HOSPITAL PHARMACIES › Section 392-5-35-5 - Licensure

Current through 2024-29, July 17, 2024
1. Application; Fees
An application for licensure as an extended hospital
					 pharmacy must be filed by the hospital in which the extended hospital pharmacy
					 is located on forms provided by the board. The application must be accompanied
					 by the license fee required by Chapter 10, Section
					 5(27) of the rules
					 of the Department of Professional and Financial Regulation, Office of
					 Professional and Occupational Regulation, entitled "Establishment of License
					 Fees." Incomplete applications will not be accepted and will be returned to the
					 applicant. The applicant shall provide the following information:
A. The name, address, telephone number and
				  email address of the person responsible for submission of the
				  application;
B. The name, physical
				  address, contact address, telephone number, email address and world wide web
				  address of the hospital;
C. All
				  trade or business names used or to be used by the extended hospital pharmacy or
				  the hospital in which it is located;
D. The names of the owner of the hospital,
				  including:
(1) If a partnership, the name,
				  contact address, telephone number and employer identification number of the
				  partnership, and the name and contact address of each partner;
(2) If a business corporation, the name,
				  contact address, telephone number and employer identification number of the
				  corporation; the name of the parent company, if any; the name, contact address
				  and title of each corporate officer and director; the name and contact address
				  of each shareholder owning 10% or more of the voting stock of the corporation,
				  including over-the-counter stock, unless the company is traded on a major stock
				  exchange and not over-the-counter; a certificate of existence from the
				  corporation's state of organization and, for corporations not organized under
				  Maine law, a certificate of authority from the Maine Secretary of
				  State;
(3) If a nonprofit
				  corporation, the name, contact address, telephone number and employer
				  identification number of the corporation; the name of the parent company, if
				  any; the name, contact address and title of each corporate officer and
				  director; the name and contact address of each voting member; a certificate of
				  existence from the corporation's state of organization and, for corporations
				  not organized under Maine law, a certificate of authority from the Maine
				  Secretary of State;
(4) If a
				  limited liability company, the name, contact address, employer identification
				  number, telephone number, fax number and email address of the limited liability
				  company; the names and mailing addresses of each member and manager; a
				  certificate of existence from the Maine Secretary of State or, for limited
				  liability companies not organized under Maine law, a certificate of authority
				  or certificate of qualification from the Maine Secretary of State; and the name
				  of the member or manager who will be representing the applicant in matters
				  before the board.
(5) If a sole
				  proprietorship, the name, contact address, telephone number and social security
				  number of the sole proprietor and the name of the business entity;
E. The hours of operation of the
				  extended hospital pharmacy during which a pharmacist will be on duty;
F. The DEA number of the hospital
				  pharmacy;
G. The name and license
				  number of the pharmacist in charge of the hospital pharmacy;
H. The name and license number of the
				  pharmacist in charge of the extended hospital pharmacy (if different than the
				  above);
I. A copy of the hospital's
				  current license from DHHS;
J.
				  Survey or Inspection Report-
(1) If the
				  hospital is accredited by an accrediting organization recognized by the Centers
				  for Medicare and Medicaid Services, the portion of the most recent survey
				  conducted by the accrediting organization that relates to pharmacy
				  services;
(2) If the hospital is
				  not accredited by an accrediting organization recognized by the Centers for
				  Medicare and Medicaid Services, the portion of the most recent report of an
				  inspection of the hospital conducted by DHHS that relates to pharmacy
				  services;
(3) All adverse findings,
				  responses, remediation plans, and follow-up surveys or follow-up inspection
				  reports related to the survey or inspection report provided pursuant to
				  subparagraph 1 or 2 above;
K. Suspension, revocation or other
				  disciplinary action taken by a federal, state or local governmental body with
				  respect to any type of pharmacy license currently or previously held by the
				  applicant;
L. Issuance of a
				  citation, warning letter or untitled letter to the applicant by the FDA, or
				  similar action taken by another governmental body;
M. A text summary of any complaints filed or
				  generated against the hospital relating to pharmacy services during the ten
				  years preceding application that includes, for each such complaint, the
				  allegations of the complaint, the complaint investigation, and the findings,
				  resolution, and any remediation or penalties ordered against or agreed to by
				  the hospital; and
N. Such other
				  information as the board may require.