02-392-5 Me. Code R. § 36-3

Current through 2024-51, December 18, 2024

Section 392-5-36-3 - Licensure

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.]

02-392 C.M.R. ch. 5, § 36-3