NAC585.550. Control of packaging, labeling operations.

     1. A licensee shall control his or her packaging and labeling operations adequately to:

     (a) Ensure that only drugs which meet the standards and specifications established in the master production and control records are distributed;

     (b) Prevent mixups during filling, packaging and labeling operations;

     (c) Ensure that correct labels and labeling are employed for drugs; and

     (d) Identify each finished product with a lot number that permits determination of the history of the manufacture and control of the batch.

     2. A code for the hour, day or shift is appropriate as a lot number for drugs manufactured or processed by equipment used in continuous production.

     3. Packaging and labeling operations must be separated by a partition or sufficient distance from operations on other drugs in a manner adequate to avoid mixups and minimize the possibility of cross-contamination.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 5.1-5.1.1.1, eff. 5-15-78]