02-392-2 Me. Code R. § 11-1

Current through 2025-03, January 15, 2025
Section 392-2-11-1 - Mail Order Prescription Pharmacy
1. Registration

A mail order prescription pharmacy that dispenses prescription drugs or devices by mail or carrier from a facility not located in this State for a patient who resides in this State shall provide the following information on forms supplied by the board, along with such other information as the board may require. Applications will not be considered for approval until they are complete. Incomplete applications will be returned to the applicant.

A. The name, physical address, contact address, telephone number, email address and world wide web address of the mail order prescription pharmacy;
B. All trade or business names used by the mail order prescription pharmacy;
C. Type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and
D. The name(s) of the owner and/or operator of the mail order prescription 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 each partner;
(2) If a corporation, the name, physical address, 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 stock 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 if such certificate is required by 13-C M.R.S.A. §1501;
(3) If a sole proprietorship, the name, contact address and social security number of the sole proprietor and the name of the business entity.
E. The DEA number;
F. Verification of licensure for all jurisdictions in which the mail order prescription pharmacy has at any time been licensed;
G. The name, contact address, telephone number and email address of the pharmacist in charge of the mail order prescription pharmacy;
H. A copy of the most recent inspection report from the state in which the drug outlet is located; and
I. The fee required by Chapter 10 of the rules of the Department of Professional and Financial Regulation, Office of Licensing and Registration, entitled "Establishment of License Fees."
2. Additional Qualifications

The board will consider the following additional factors in determining the applicant's eligibility for registration as a mail order prescription pharmacy:

A. The applicant's past experience in the dispensation of prescription drugs;
B. The furnishing by the applicant of false or fraudulent material in any application made in connection with the dispensation of prescription drugs;
C. Suspension or revocation by federal, state or local government of any license currently or previously held by the applicant for the dispensation of prescription drugs;
D. Compliance with previously granted licenses of any kind; 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 mail order prescription pharmacies.
3. Separate Applications for Separate Facilities

The owner must file a separate application for each facility that dispenses prescription drugs to Maine residents.

4. Toll-Free Telephone Access to Pharmacist

The mail order prescription pharmacy shall provide a toll-free telephone number to enable communication between a Maine patient and a pharmacist at the drug outlet who has access to the patient's records. The toll-free telephone number must appear on all prescription labels. Toll-free telephone access to a pharmacist must be available for a minimum of 40 hours per week.

02-392 C.M.R. ch. 2, § 11-1