NAC585.420. Components: Retention of sample.

A licensee shall retain an appropriately identified, reserve sample of each active ingredient, consisting of at least twice the quantity necessary for all required tests, except those for sterility and determination of the presence of pyrogens, for at least 2 years after distribution of the last drug lot incorporating the component has been completed, or 1 year after the expiration date of the last drug lot, whichever period is longer. The samples must be representative and adequately identified.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.3.8, 4.5.2.1 & 4.5.3, eff. 5-15-78]