Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 36 - LICENSURE OF OPIOID TREATMENT PROGRAMS › Section 392-5-36-3 - Licensure

Current through 2024-29, July 17, 2024
1.
Application; Fees
An application for licensure as an opioid treatment program
					 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 opioid treatment program;
C. All trade or business names used or to be
				  used by the opioid treatment program;
D. The names of the owner of the opioid
				  treatment program, 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
				  opioid treatment program which details the usage of each area, including the
				  waiting area, consultation area, dispensing area and drug storage
				  area;
F. Confirmation that the
				  following equipment is available on site:
(1)
				  An automated data processing system;
(2) Containers which meet official compendia
				  standards, available with closures that meet Federal Poison Prevention
				  Packaging Act of 1970 requirements, as well as regular closures;
(3) Prescription labels imprinted or
				  computer-generated with the name, address, and telephone number of the opioid
				  treatment program that do not contain any symbol or background logo that
				  interferes with the reading and interpretation of any information written by
				  the pharmacist on the label;
(4)
				  Auxiliary labels;
(5) Sufficient
				  equipment to maintain the scope of practice;
G. Demonstration of compliance with the
				  barrier, alarm and security camera requirements of Chapter 13, Section 6 of the
				  board's rules;
H. The name and
				  license number of the pharmacist in charge of the opioid treatment program;
I. 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
J. Such other
				  information as the board may require.