Section 392-5-37-3 - Licensure1.Application; FeesAn 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; andI. Such other information as the board may require.2.Additional QualificationsThe board will consider the following additional factors in determining the applicant's eligibility for licensure as a sterile compounding pharmacy:
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; andE. 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 ApplicationA. 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 sterile compounding pharmacy 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 ActionNo 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; orE. Request a hearing to contest a condition imposed by the board.F. 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 FacilityThe owner of a sterile compounding pharmacy must file a separate application for each facility engaged in the compounding of sterile pharmaceuticals.
6.License Term; RenewalAll sterile compounding pharmacy 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 InformationUpon a change of ownership, the sterile compounding pharmacy must file a new application with the board no less than 7 days prior to the change. Upon a change of location, the sterile compounding pharmacy 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 TheftA sterile compounding pharmacy 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.
02-392 C.M.R. ch. 5, § 37-3