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(1) All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(a) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c) have a physically separate area for storage of all prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

(d) be maintained in a clean and orderly condition; and

(e) be free from infestation by insects, rodents, birds, or vermin of any kind.

(2) All facilities used for wholesale drug distribution shall be secure from unauthorized entry as provided for in 37-7-604 , MCA, and as follows:

(a) access from outside the premises shall be kept to a minimum and be well-controlled;

(b) the outside perimeter of the premises shall be well-lighted; and

(c) entry into areas where prescription drugs are held shall be limited to authorized personnel.

(3) All facilities shall be equipped with a security system to detect entry after hours.

(4) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(5) All drugs shall be stored at temperatures and under conditions in accordance with the requirements, if any, in the labeling of such drugs, or with requirements in the current edition of the United States Pharmacopeia/National Formulary, published by the United States Pharmacopeia Convention Inc., which is available for inspection at the pharmacy library at the University of Montana School of Pharmacy and Allied Health Sciences, Missoula, MT 59812-1075.

(a) If no storage requirements are established for a drug, the drug may be held at "controlled room temperature," as defined in the United States Pharmacopeia/National Formulary, to help ensure that its identity, strength, quality and purity are not adversely affected.

(b) Manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be used to document proper storage of prescription drugs.

(c) The record keeping requirements in these rules shall be followed for all stored drugs.

(6) A stock of prescription drugs, adequate to service the ordinary needs of practitioners and pharmacies with which the wholesaler transacts business, must be maintained.

(7) A wholesaler may not maintain a stock of controlled substances unless the wholesaler ordinarily sells controlled substances to practitioners and pharmacies with which the wholesaler transacts business.

History: 37-7-201, 37-7-610, MCA; IMP, 37-7-604, MCA; NEW, 1992 MAR p. 2135, Eff. 8/14/92; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2006 MAR p. 1615, Eff. 6/23/06.

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