24.174.1212 MINIMUM REQUIREMENTS FOR ESTABLISHMENT AND MAINTENANCE OF DRUG DISTRIBUTION RECORDS

(1) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution of or other disposition of drugs. These records shall include the following information:

(a) the source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

(b) the identity and quantity of the drugs received and distributed or disposed of;

(d) evidence of the existence of a written franchise, license, or other agreement between a manufacturer and wholesaler to distribute prescription drugs;

(e) evidence of completion of two or more purchases of prescription drugs in any six month period; and

(f) a complete list of all wholesale distributors and manufacturers from whom the wholesaler purchased prescription drugs within the last year.

(2) Inventories and records shall be made available for inspection and photocopying by authorized federal, state, or local law enforcement agency officials for a period of two years following disposition of the drugs.

(3) Records described in this part that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at central locations apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by an authorized official of a federal, state, or local law enforcement agency.

(4) Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory and distribution of drugs. They must include policies and procedures for identifying, recording and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

(5) Wholesale drug distributors shall include the following written policies and procedures:

(a) a procedure where the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement, if the deviation is temporary and appropriate;

(b) a procedure to be followed for handling recalls and withdrawals of drugs. The procedure shall be adequate to deal with recalls and withdrawals due to:

(i) an action initiated at the request of the Food and Drug Administration, or other federal, state or local law enforcement or other government agency, including the Board of Pharmacy;

(ii) any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(iii) any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(c) a procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(d) a procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of the drugs. This documentation shall be maintained for two years after disposition of the outdated drugs.

History: 37-7-201, 37-7-610, MCA; IMP, 37-7-604, 37-7-609, 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.