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Licensing requirements for Maine healthcare and pharmaceutical companies and
individuals.
This page provides an overview of healthcare and pharmaceutical industry licensing
in Maine for individuals and businesses. You will find state requirements, application
fees, filing instructions, and more. For assistance with licensing, please contact us to learn about our software and
managed license services.
Once your license is issued it is immediately visible online with an “active” status. Licenses are printed off-site and require at least 14 business days for delivery.
Before you Apply:
The person who signs the application must be an owner or officer of the entity
DEA number - if not applicable, you must provide a written statement
You must designate the type of facility you will operate
Corporations and LLCs must submit a Certificate of Existence from the State of origin
Corporations and LLCs not organized under Maine law, a Certificate of Authority from the Maine Secretary of State is required
Organizational Chart - See chapter 11, Sec 1(1)(D)(2)) for details
Non-publicly traded corporations - —List the name and contact address of each shareholder owning 10% or more of the voting stock of the corporation, including over-the-counter stock
If any corporate officer, owner, or the designated officer of this entity has been convicted of any criminal offense, include:
A detailed explanation
A copy of the court judgment and decision
A motor vehicle report (if applicable)
If any state or territory of the U.S., province/territory of Canada, or any other jurisdiction EVER denied this entity’s or predecessor entity’s application for any type of examination, professional license, certificate or registration, or taken any disciplinary action against the license issued to you in that jurisdiction (including, but not limited to, warning, reprimand, fine, suspension, revocation or restrictions in permitted practice, probation with or without monitoring, include:
A list of jurisdictions and the date of discipline
A copy of the consent agreement or decision and order for each
A detailed explanation of the situation
If you you ever been denied registration by the U.S. Drug Enforcement Administration (DEA) or have you ever had a DEA Registration modified, restricted, suspended or revoked, or if any state or province denied, restricted, modified, suspended or revoked your state permit to prescribe or dispense controlled substances, include:
DEA or other state of province's action
A copy of the official action by the entity
A detailed explanation of the situation
List each state or jurisdiction the applicant has at any time held a pharmaceutical license, including controlled substance licenses
Most recent inspection report from the state in which this facility is located
You must disclose all states in which you hold or have held a license and sign an affirmation statement to this effect
Required Attachments:
Certificate of Existence from the State of origin
Certificate of Authority from the Maine Secretary of State
Organizational Chart
A copy of the consent agreement or order issued by the Board or jurisdiction is enclosed if licensure discipline has been indicated and a detailed explanation of the situation
A list of each state or jurisdiction the applicant has at any time held a pharmaceutical license, including controlled substance licenses
A copy of your most recent inspection report from the state in which this facility is located
Mail to: STATE OF MAINE DEPARTMENT OF PROFESSIONAL & FINANCIAL REGULATION OFFICE OF PROFESSIONAL AND OCCUPATIONAL REGULATION 35 State House Station, Augusta, Maine 04333-0035
Agency Fee:
$200
Notes:
Possible PIC waivers:
Minimum 40 hours per week of operation
Practice by the pharmacist in charge at the drug outlet for which he or she has registered for a minimum of 30 hours per week or 50% of the hours that the retail drug outlet is open, whichever is less.
Before you Apply:
If you are a central fill drug outlet, identify whether you have a contr act or has the same ownership
A central fill drug outlet or central processing center that processes, fills or refills a prescription drug order must have a contract with or have the same owner as the retail drug outlet or other health care facility identified in Section 1(1) of the Board of Pharmacy code, from which it received the prescription drug order.
The contract must include provisions that protect the confidentiality of patient information.
Controlled Substance Registration - In addition to a pharmacy license, controlled substance registration registration is required in many states for pharmacies that distribute controlled substances.
NABP (National Association of Boards of Pharmacy) - Host a variety of programs and resources relating to pharmacist and pharmacy licensure and examination.
Pharmacist in Charge - A licensed pharmacist designated by a pharmacy to act as the party responsible for compliance with regulations.
VPP (Verified Pharmacy Program) - A program run by NABP that allows state boards to share information and more easily register out-of-state pharmacies.
Filing fees depend on your individual situation. We do our best to calculate your filing fees
upfront and collect those fees today so we can get started. Your specialist will determine your
exact filing fees and invoice additional fees if required.
