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Licensing requirements for Montana healthcare and pharmaceutical companies and
individuals.
This page provides an overview of healthcare and pharmaceutical industry licensing
in Montana 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.
$240 application fee + $75 dangerous drug act registration fee + $75 technician utilization plan fee (if applicable)
Turnaround:
The application takes up to 30 days to process from the time it is received in the Board office
Notes:
Prior to conducting business, a pharmacy must secure a license and be registered with the Board
Owner of the pharmacy is a registered pharmacist in good standing in the state of Montana OR
The manager or supervisor of the pharmacy is a registered pharmacist in good standing in the state of Montana and that the pharmacist will be actively and regularly engaged and employed in and responsible for the management, supervision and operation of such pharmacy
The license registers the pharmacy to which it is issued and is not transferable. It is issued on the application of the registered pharmacist-in-charge, and which contains the sworn statement that the pharmacy will be operated in accordance with the provisions of the law
To operate, maintain, open or establish more than one pharmacy, separate applications shall be made and separate licenses issued for each
Upon closure of a certified pharmacy, the original license becomes void and must be surrendered to the Board within ten days
Registered pharmacy technicians or technicians-in-training may be utilized pursuant to the written policies and procedures of the institution pharmacy. Exemptions to established ratios as defined in ARM 24.174.711 may be granted with Board approval.
Each home infusion pharmacy must be licensed with both the Board of Pharmacy and with the Department of Health and Human Services (DPHHS). Information about licensing with DPHHS can be obtained at www.dphhs.mt.gov or by calling (406)444-1575
Telepharmacy 24.174.1302 ARM:
A remote telepharmacy site shall be connected to its parent pharmacy via computer, video, and audio link
A site cannot be licensed as a remote telepharmacy site if it is located within a twenty-mile radius of an existing pharmacy
The registered pharmacy technician present at the remote telepharmacy site must be currently registered with the Board, current certification with the Pharmacy Technician Certification Board (PTCB) or Exam for Certification of Pharmacy Technician (ExCPT) and have at least 500 hundred hours experience as a pharmacy technician, technician-in training, or experience deemed as equivalent by the Board.
When the application file is complete, it will be processed and considered by Board staff for permanent licensure. The applicant may be notified if additional information is required or if required to appear before the Board for an interview.
If the application is considered a non-routine application, there may be a delay in the processing of the application. You may be requested to provide additional information, or make a personal appearance before the Board during a regularly scheduled Board meeting, and/or the application may require Board consideration. Non-routine applications may take up to 120 days to process.
Keep the Board office informed at all times of any address changes, changes in license status, and complaints or proposed disciplinary action. This is essential for the timely processing of applications and subsequent licensure.
Required Attachments:
Complete the Dangerous Drug Act application if this pharmacy will be dispensing controlled substances
Complete the Technician Utilization Plan application if pharmacy technicians will be employed in this facility
Complete the Pharmacist-in-Charge Agreement form
Complete the Pharmacist-in-Charge Agreement (Non-Pharmacist Owner) form if applicable
$240 application fee + $75 dangerous drug act registration fee
Turnaround:
Please allow 30 days for processing from the date that the Board has a complete routine application
Notes:
Each pharmacy that provides home infusion therapy services to Montana must be licensed with both the Board of Pharmacy and the Department of Public Health and Human Services (DPHHS)
When the application file is complete, it will be processed and considered by Board staff for permanent registration. The applicant may be notified if additional information is required or if required to appear before the Board for an interview.
If the application is considered a non-routine application, there may be a delay in processing of the application. You may be requested to provide additional information, or make a personal appearance before the Board during a regularly scheduled Board meeting and/or the application may require Board consideration. Non-routine applications may take up to 120 days to process.
Verification of licensure must be sent directly to the state board in which the business is located or the pharmacist-in-charge is employed. Please contact the state board prior to sending the request as some states may charge a fee for verification.
Keep the Board office informed at all times of any address changes, changes in license status and complaints or proposed disciplinary action. This is essential for timely processing of applications and subsequent licensure
PRODUCT SELECTION OF PRESCRIBED DRUGS – NOTIFICATION:
An out-of-state mail service pharmacy may not substitute a prescription drug unless the substitution is made in compliance with the laws of this state and the rules and regulations of the Board.
An out-of-state mail service pharmacy may not dispense a substitute drug product to a resident of this state without notifying the patient of the substitution either by telephone or in writing.
Before you Apply:
No out-of-state pharmacy may ship, mail or deliver prescription drugs and/or devices to a patient in this state unless registered by the Montana Board of Pharmacy.
Proof of registration and good standing with the Montana Secretary of State information available
If conducting online pharmacy services, proof of registration and good standing with the National Association of Boards of Pharmacy (NABP) Digital Pharmacy Accreditation (formerly VIPPS)
Be prepared to provide copies of records of legend drugs and/or devices dispensed to Montana patients
Supply upon request, all information needed by the Montana Board of Pharmacy to carry out the Board’s responsibilities under the statutes and regulations pertaining to out-of-state mail service pharmacies
Provide proof of maintaining pharmacy hours that permit the timely dispensing of drugs to Montana patients and provide reasonable access for the Montana patients to consult with a licensed pharmacist about such patients’ medications
Provide the toll-free telephone communication consultation between a Montana patient and a pharmacist at the pharmacy who has access to the patient’s records, and ensure that said telephone number(s) will be placed upon the label affixed to each legend drug container. Toll-free telephone service must be available at least 6 days a week and for 40 hours a week. A toll-free telephone number shall also be provided to the Board to allow for compliance with all information requests by the Board.
Identify a pharmacist in charge of dispensing prescriptions for shipment to Montana (not required to be licensed in Montana)
PHARMACY TECHNICIANS:
Any application for out-of-state mail service pharmacy registration from a facility located in a state which does not regulate the use of pharmacy technicians may not allow a pharmacist to supervise more than one supportive person at any one time in the compounding or dispensing of prescription drugs, unless approved by the Board.
Any application for out-of-state mail service pharmacy licensure from a facility located in a state which does regulate the use of pharmacy technicians shall provide information on the supervisor to technician ratio allowed in the resident state, and submit a utilization plan for the employment of pharmacy technicians.
INSPECTIONS:
If the licensing or regulatory agency of the state in which an out-of-sate mail service pharmacy is domiciled fails or refuses to inspect the out-of-state mail service pharmacy after receiving a request for an inspection from the Board of this state, the Board may cancel the out-of-state pharmacy’s right to do business in this state unless the out-of-state pharmacy agrees to an onsite inspection by the Board of this state.
Provide the license number and names of any current or previous licensed entities
Name and license number of the PIC
Describe the scope and type of services to be provided by this pharmacy
Disclose any previous criminal, civil, or license discipline
Disclose any mental or medical conditions that may qualify for participation in the Montana Professional Assistance Program
Attach a copy of your current Drug Enforcement Agency (DEA) registration
Required Attachments:
All attachments must be on 8 ½” x 11” paper
Copy of your current DEA registration if applying for Dangerous Drug Dispenser Registration
Copy of last State Inspection
Copy of a Technician Utilization Plan
Proof of licensure with the Montana DPHHS if providing home infusion therapy services
Proof of registration with Montana Secretary of State
National Practitioner Data Bank (NPDB) self-query
Verification of licensure in good standing in the state in which the business is located (Page 11)
Verification of licensure in good standing of the Registered Pharmacist-in-Charge (Page 12)
Statement of Pharmacist in Charge (Page 15)
Pharmacist in Charge Agreement for non-pharmacist owners (Page 16)
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.