Last updated: 11/2/2023
Wholesale Drug Distributor
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Description
APPLICATION FOR WHOLESALE DRUG DISTRIBUTOR. Every person engaged in manufacturing, wholesale distribution, which includes reverse wholesale distribution, or selling of drugs, medicine, chemicals, poisons for medicinal purposes, medical gases, or legend device other than to the consuming public or patient, in the state of Montana, shall be licensed annually by the Board. File an application on a form prescribed by the Board and pay the appropriate licensing and registration fees. No license may be issued to any wholesale Distributor whose intended place of business is a personal residence. A separate license is required for each separate location where drugs are stored. If a wholesaler distributes prescription drugs from more than one facility, the wholesaler must obtain a license for each facility. Wholesale drug distributors located in Montana, applying for initial licensure, shall pass an inspection by a pharmacy inspector or other agent of the Board before a license is issued. Legal entity registered and in good standing with the Montana Secretary of State by applying for a certificate of authority and identifying a registered agent. Wholesale drug distributors who deal in controlled substances shall register with the Board and with the DEA, and shall comply with all applicable, state, local and DEA regulations. Manufacturers, distributors, and suppliers of medical gases shall operate in compliance with applicable federal, state, and local laws and regulations. Manufacturers, distributors, and suppliers of medical gases shall register with the Board to obtain the appropriate endorsement on their Wholesale Drug Distributor license. If out-of-state, proof of corresponding licensure in good standing in the state in which the applicant resides. A schematic (floor plan) of office, wholesale area and storage areas. A description of the security system and security measures in place. www.FormsWorkflow.com





