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.
2.
Additional Qualifications
The board will consider the following additional factors in
determining the applicant's eligibility for licensure as an opioid treatment
program:
A. The applicant's past
experience in the dispensing or compounding of prescription drugs;
B. The furnishing by the applicant of false
or fraudulent material in any application made in connection with the
dispensing or compounding of prescription drugs;
C. 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;
D. Issuance of a
citation, warning letter or untitled letter to the applicant by the FDA, or
similar action taken by another governmental body; and
E. Compliance with the requirements to
maintain and/or to make available to the board or to federal, state or local
law enforcement officials those records required to be maintained by
pharmacies.
3.
Processing of Application
A. The
board shall review the application for compliance with the pharmacy law and
rules and shall issue a license upon a determination that operation of the
opioid treatment program will be in the best interest of the public health and
welfare.
B. Following review of the
application the board may approve the application, preliminarily deny the
application, approve the application with conditions, direct the applicant to
resubmit the application with specific modifications, request further
information from the applicant, or investigate any of the information contained
in the application. A denial shall identify the specific deficiencies in the
application that resulted in the denial.
4.
Response by Applicant to Adverse
Board Action
No later than 30 days following receipt of written notice
from the board, or within such longer or shorter time as the board may specify,
an applicant may, as the case may be-
A. Submit an application with modifications
requested by the board;
B. Furnish
additional information requested by the board;
C. Make site modifications requested by the
board;
D. Request a hearing to
contest a preliminary denial; or E. Request a hearing to contest a condition
imposed by the board.
Failure of the applicant to act within the applicable time
period shall result in the automatic denial of the application without need of
further action by the board or, in the case of applications conditionally
approved, finality of the conditions.
5.
Separate License for Each
Facility
The owner of an opiate treatment program must file a
separate application for each facility that dispenses or administers
opioids.
6.
License
Term; Renewal
All opioid treatment program licenses expire annually on
December 31. A licensee may renew the license by completing the renewal
application form provided by the board and remitting 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."
7.
Change of Ownership, Location or
Application Information
Upon a change of ownership, the opioid treatment program
must file a new application with the board no less than 7 days prior to the
change. Upon a change of location, the opioid treatment program must file a new
application with the board no less than 7 days prior to the change. The
licensee shall notify the board of any other change in the information provided
on its application within 10 days after the change.
8.
Notice of Termination of Employment
of Pharmacist For Drug-Related Reasons or Theft
An opioid treatment program shall notify the board of the
termination of employment of a pharmacist for drug-related reasons or theft as
required by Chapter 30, Section 1(26) of the board's rules.
9.
Alteration of Dispensing Area
An opiate treatment program may not alter the physical
dimensions of the dispensing area or add or change the doors, windows or other
means of access to the dispensing area prior to receiving approval from the
board. The opiate treatment program must provide a scaled drawing of the
proposed alteration at the time it requests approval.
[NOTE: Cosmetic changes (e.g., carpet replacement) and
changes that are non-structural in nature (e.g., relocation of shelving) do not
require board approval.]
