Institutional Pharmacy Renewal

Montana Board of Pharmacy MAIL ORDER PHARMACY REVISED 10/17 Page 1 of 15 MONTANA BOARD OF PHARMACY (301 S PARK, 4TH FLOOR, HELENA, MT 59601 - Delivery) P. O. Box 200513 Helena, Montana 59620-0513 PHONE (406) 841-2300 FAX (406) 841-2344 E-MAIL: dlibsdpha@mt.gov WEBSITE: pharmacy.mt.gov APPLICATION FOR: OUT-OF-STATE MAIL SERVICE PHARMACY ILLEGIBLE AND INCOMPLETE APPLICATIONS WILL BE RETURNED. (Please allow 30 days for processing from the date that the Board has a complete routine application) BUSINESSES ARE NOT PERMITTED TO OPERATE IN MONTANA IN ANY MANNER WITHOUT AN ACTIVE MONTANA REGISTRATION REGISTRATION REQUIREMENTS (24.174.1001-1009 ARM) Out-of-State Mail Service Pharmacies: No out-of-state pharmacy shall ship, mail or deliver prescription drugs and/or devices to a patient in this state unless registered by the Montana Board of Pharmacy. Legal entity registered and in good standing with the Montana Secretary of State information available at www.sos.mt.gov . Registered and in good standing with the National Association of Boards of Pharmacy Verified Internet Pharmacy Practice Sites (VIPPS) if registered after June 1, 2001. Maintain, in readily retrievable form, 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 Board222s responsibilities under the statutes and regulations pertaining to out-of-state mail service pharmacies. Maintain 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 patients222 medications. Provide toll-free telephone communication consultation between a Montana patient and a pharmacist at the pharmacy who has access to the patient222s 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). 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). Information about licensing with DPHHs is available at www.dphhs.mt.gov or call (406) 444-1575. FEES: $240 (Non-Refundable) - Application Fee $75 (Non-Refundable) - Montana Dangerous Drug Act Dispenser Fee **Make check or money order payable to the Montana Board of Pharmacy** DOCUMENTS: The following documents must be submitted to the Board office in order to complete your license application. Please make 8 275224 x 11224 copies of the following and submit with your application. Attach a 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. American LegalNet, Inc. www.FormsWorkFlow.com Montana Board of Pharmacy MAIL ORDER PHARMACY REVISED 10/17 Page 2 of 15 Proof of registration with Montana Secretary of State. Go to 223Business Services224 then to 223Forms224 then 223Business Forms224 click on type of ownership or operation 223Foreign224 (as this business is foreign to the State of Montana) then to 223Certificate of Authority224. ADDITIONAL FORMS TO BE SUBMITTED FOR AN APPLICATION TO BE COMPLETE: National Practitioner Data Bank (NPDB) self-query. This form can be obtained by calling NPDB at 800-767-6732 or visit www.npdb.hrsa.gov . This form must be mailed directly to the address indicated in the instructions. The results will come to you; upon receipt please forward them in the original sealed envelope to the Board office. Go to 223Perform a Self-Query224 and to 223Perform a Self-Query on an Organization224. Verification of licensure in good standing in the state in which the business is located. Verification of licensure in good standing of the Registered Pharmacist-in-Charge. If the pharmacy provides home infusion therapy services to Montana must be licensed with both the Board of Pharmacy and with the Department of Public Health and Human Services (DPHHS). Information about licensing with DPHHS can be obtained at www.dphhs.mt.gov or call (406)444-1575. APPLICATION PROCEDURES: 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. PROCESSING PROCEDURES: Once a routine application is complete, the application takes up to 30 days to process from the time it is received in the Board office. The applicant will be notified in writing of any deficient or missing items from the application file. Once a routine application is processed and approved a permanent registration will be issued. ADDITIONAL LAW and RULE INFORMATION: Identification of Pharmacist-in-Charge (PIC) Be licensed in good standing in the state in which the out-of-state mail service pharmacy is located (PIC not required to be licensed in the State of Montana). Be properly listed on the application form prescribed by the Board. Comply with all applicable Montana laws and rules. Notify the Montana Board promptly of any relevant changes in employment or address, etc. Notify the Montana Board promptly of any disciplinary actions initiated and/or finalized against the pharmacist222s license. AGENT OF RECORD: Pursuant to ARM 24.174.1002 Conditions of Registration, any out-of-state mail service pharmacy must be a legal entity registered and in good standing with the Montana Secretary of State with a registered agent in Montana for service of process designated. The Certificate of Authority identifying the business entity and their Registered Agent must be submitted as part of the application. Go to www.sos.mt.gov Business Services and then Business Forms to apply for the Certificate of Authority. American LegalNet, Inc. www.FormsWorkFlow.com Montana Board of Pharmacy MAIL ORDER PHARMACY REVISED 10/17 Page 3 of 15 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,