§ 106-145.9. Written procedures concerning prescription drugs and lists of responsible persons. - North Carolina Statutes

§ 106‑145.9. Written procedures concerning prescription drugs and lists of responsiblepersons.

(a)        Procedures. – A wholesale distributor shall establish,maintain, and adhere to written procedures for the receipt, security, storage,inventory, and distribution of prescription drugs.  These shall include all ofthe following:

(1)        A procedure for identifying, recording, and reporting a lossor theft of a prescription drug.

(2)        A procedure for correcting all errors and inaccuracies ininventories of prescription drugs.

(3)        A procedure whereby the oldest approved stock of aprescription drug is distributed first.  The procedure may permit deviationfrom this requirement, if the deviation is temporary and appropriate.

(4)        A procedure for handling recalls and withdrawals ofprescription drugs that adequately addresses recalls and withdrawals due to anyof the following:

a.         An action initiated at the request of the Food and DrugAdministration or other federal, State, or local law enforcement or othergovernmental agency, including the Department.

b.         Any voluntary action by the manufacturer to remove defectiveor potentially defective prescription drugs from the market.

c.         Any action undertaken to promote public health and safety byreplacing existing prescription drugs with an improved product or new packagedesign.

(5)        A procedure to ensure that the wholesale distributorprepares for, protects against, and handles any crisis that affects security oroperation of any facility in the event of a strike, a fire, flood, or othernatural disaster, or another emergency.

(6)        A procedure to ensure that any outdated prescription drugsare segregated from other prescription drugs and either returned to themanufacturer or destroyed.

(b)        Responsible Persons. – A wholesale distributor shallestablish and maintain lists of officers, directors, managers, and otherpersons in charge of the distribution, storage, or handling of prescriptiondrugs.  The lists shall include a description of the duties of those on thelist and a summary of their qualifications. (1991, c. 699, s. 2.)