Section 13.15. Written policies and procedures.

  A distributor shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. A distributor shall include in their written policies and procedures the following:

(1)  A procedure to ensure that the oldest approved stock of a prescription drug is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate.

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

(a) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other governmental agency, including the board;

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

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

(3)  A procedure to ensure that a distributor prepares for, protects against, and handles 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.

(4)  A procedure to ensure that any outdated prescription drugs are segregated from other products and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for 3 years after disposition of the outdated drugs.

History: Cr. Register, July, 1992, No. 439 , eff. 8-1-92; EmR0815 : emerg. am. (intro.), (1), (2) (intro.), (b) and (4), eff. 6-1-08; CR 08-051 : am. (intro.), (1), (2) (intro.), (b) and (4) Register November 2008 No. 635 , eff. 12-1-08.