[§328-121]  Written policies andprocedures.  Wholesale distributors shall establish, maintain, and followwritten policies and procedures for the receipt, security, storage, inventory,and distribution of prescription drugs, including policies and procedures foridentifying, recording, and reporting losses or thefts and for correcting allerrors and inaccuracies in inventories.  Wholesale distributors shall includein their written policies and procedures the following:

(1)  A procedure whereby the oldest approved stock ofa prescription drug is distributed first.  The procedure may permit deviationfrom this requirement if the deviation is temporary and appropriate.

(2)  A procedure for handling recalls and withdrawalsof prescription drugs.  The procedure shall be adequate to deal with recallsand withdrawals caused by:

(A)  Any action initiated at the request of thedepartment, the Food and Drug Administration, or any other federal, state, orlocal law enforcement or other government agency;

(B)  Any voluntary action by the manufacturerto remove defective or potentially defective drugs from the market; or

(C)  Any action undertaken to promote publichealth and safety by replacing existing merchandise with an improved product ornew package design.

(3)  A procedure to ensure that the distributorprepares for, protects against, and handles properly any crisis that affectssecurity or operation of any facility in the event of strike, fire, flood, orother natural disaster, or in other emergencies.

(4)  A procedure to ensure that all outdatedprescription drugs are segregated from other drugs and either returned to themanufacturer or destroyed.  This procedure shall require written documentationof the disposition of outdated prescription drugs, which documentation shall bemaintained for five years after disposition of the outdated drugs. [L 1992, c196, pt of §2]