NAC585.430. Laboratory controls.

     1. The laboratory controls of a licensee must include the establishment of scientifically sound and appropriate specifications, standards and test procedures to ensure that components, drugs in process and finished products conform to appropriate standards of identity, strength, quality and purity.

     2. The laboratory controls must also include the establishment of master records containing appropriate specifications for the acceptance of each lot of drug components, product containers and their components used in the production and packaging of drugs and a description of the sampling and testing procedures used.

     3. The records must also provide for appropriate retesting of drug components, product containers and their components subject to deterioration.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.5-4.5.2 & 4.5.2.2, eff. 5-15-78]