NAC585.560. Labeling: Controls; disclosure.

     1. A licensee shall include the following controls in his or her packaging and labeling operations:

     (a) An inspection of the facilities before use to ensure that all drugs and materials which were previously used for packaging and labeling have been removed.

     (b) The holding of labels and package labeling upon receipt, pending their review and proofing against an approved final copy by a competent and responsible person, to ensure that they are accurate regarding identity and content and are in conformity with the approved copy before they are released to inventory.

     (c) The maintenance and storage of each type of label and package labeling, representing different products, strength, dosage forms or quantity of contents in a manner that will prevent mixups and provide proper identification.

     (d) A suitable system for ensuring that only current labels and package labeling are retained and that stocks of obsolete labels and package labeling are destroyed.

     (e) Restriction of access to labels and package labeling to authorized personnel.

     (f) Avoidance of “gang” printing of cut labels, cartons or inserts where the labels, cartons or inserts are:

          (1) For different products or different strengths of the same products; or

          (2) Of the same size and have identical or similar format or color schemes.

     (g) If “gang” printing is employed, added control procedures must be provided for. In devising these added controls, the licensee shall consider the problems related to sheet layout, stacking, cutting and handling during and after printing.

     (h) Strict control of the package labeling issued for use with the drug. Such labeling must be carefully checked by a competent and responsible person for identity and conformity to the labeling specified in the production record for the batch. The record must identify the labeling and the quantities issued and used and must reasonably reconcile any discrepancy between quantities of the finished drug and the quantities of the issued labeling. All excess package labeling which bears lot numbers must be destroyed. If any significant, unexplained discrepancy occurs, the licensee shall carry out an investigation pursuant to NAC 585.520.

     (i) Adequate examination or laboratory testing of representative samples of finished products after packaging and labeling to safeguard against any errors in the finishing operations and to prevent distribution of any batch until all required tests have been made.

     2. Each label on a container of amygdalin or procaine hydrochloride must state that the drug has not been approved as a drug by the United States Food and Drug Administration or by the State of Nevada.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 5.1.2-5.2, eff. 5-15-78]—(NAC A 9-17-82)