Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-3 - Licensure

Current through 2024-29, July 17, 2024
1.
Application; Fees
An application for licensure as a sterile compounding
					 pharmacy must be filed on forms provided by the board. The application must be
					 accompanied by the application and license fees 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 sterile compounding pharmacy;
C. All trade or business names used or to be
				  used by the sterile compounding pharmacy;
D. The names of the owner of the sterile
				  compounding pharmacy, 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. A scaled drawing and floor plan of the
				  sterile compounding pharmacy which details the usage of each area;
F. The name and license number of the
				  pharmacist in charge of the sterile compounding pharmacy;
G. Demonstration of compliance with the
				  barrier, alarm and security camera requirements of Section 5,
				  6 and
				  7 of this chapter;
H. Upon request of the board, all plumbing
				  permits, electrical permits, certificates of occupancy and other documents
				  necessary to show full compliance with all federal, state and local laws and
				  rules; and
I. Such other
				  information as the board may require.