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24.174.1201    WHOLESALE DRUG DISTRIBUTOR LICENSING

(1) Every person engaged in manufacturing, wholesale distribution, which includes reverse wholesale distribution, or selling of drugs, medicines, chemicals, poisons for medicinal purposes, medical gases, or legend devices other than to the consuming public or patient in the state of Montana, shall be licensed annually by the board. Each applicant shall:

(a) be a legal entity registered and in good standing with the Montana Secretary of State;

(b) file an application on a form prescribed by the board;

(c) pay the appropriate licensing and registration fees; and

(d) meet the requirements of 37-7-604, MCA.

(2) The wholesale drug distributor license shall be posted in a conspicuous place in the wholesaler's place of business for which it is issued.

(3) No license may be issued to any wholesale distributor whose intended place of business is a personal residence.

(4) Wholesale drug distributors located in Montana, applying for initial licensure, shall pass an inspection by a pharmacy inspector or other agent of the Board of Pharmacy before a license is issued.

(5) 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.

(6) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws and regulations. 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.

(7) 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.

History: 37-7-201, 37-7-610, MCA; IMP, 37-7-603, 37-7-604, 37-7-605, 37-7-606, MCA; NEW, 1992 MAR p. 2135, Eff. 8/14/92; AMD, 1999 MAR p. 2438, Eff. 10/22/99; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2010 MAR p. 2968, Eff. 12/24/10; AMD, 2012 MAR p. 506, Eff. 3/9/12.

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