Montana Healthcare and Pharmaceutical Licensing

Mail Order Pharmacy Application

$240 application fee + $75 dangerous drug act registration fee

Please allow 30 days for processing from the date that the Board has a complete routine application

• 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.

• 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

• 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)

Mail Order Pharmacy Renewal Form

$240

Annually by November 30.

Outpatient Surgical Center Application

$45 application fee + $75 dangerous drug act registration fee

Outpatient Surgical Center Renewal Form

$45

Annually by November 30.

Wholesale Drug Distributor Application

Online

$240 application fee + $100 dangerous drug act registration fee + $100 dangerous drug manufacture fee + $75 medical gas supplier fee (if applicable) + $75 medical gas distributor fee (if applicable)

Wholesale Drug Distributor Renewal Form

$240

Annually by November 30.