[§328-121] Written policies and procedures.

279 words·~1 min read·/hi/chapter-328/328-121

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[§328-121] Written policies and procedures. Wholesale distributors shall establish, maintain, and follow written policies and procedures 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. Wholesale distributors shall include in their written policies and procedures the following:

(1)A procedure whereby 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 for handling recalls and withdrawals of prescription drugs. The procedure shall be adequate to deal with recalls and withdrawals caused by:

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

(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 replacing existing merchandise with an improved product or new package design.

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

(4)A procedure to ensure that all outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall require written documentation of the disposition of outdated prescription drugs, which documentation shall be maintained for five years after disposition of the outdated drugs. [L 1992, c 196, pt of §2]