La. Admin. Code tit. 51 § VI-1531

Current through Register Vol. 50, No. 11, November 20, 2024

Section VI-1531 - Packaging and Labeling [formerly paragraph 6:208]

A. Packaging and labeling operations shall be controlled to assure that only those products that have met the standards and specifications in their master production and control records shall be distributed; to prevent mix-ups between drugs during filling, packaging and labeling operations to assure that correct labels and labeling are employed for the drug and to identify the finished product with a lot or control number that permits determination of the history of the manufacture and control of the batch. An hour, day or shift code is appropriate as a lot or control number for drug products manufactured or processed in continuous production equipment. Packaging and labeling operations shall:

1. [formerly paragraph 6:208-1] be separated (physically or spatially) from operations on other drugs in a manner so as to avoid mix-ups and minimize cross-contamination. Two or more packaging or labeling operations having drugs, containers or labeling similar in appearance shall not be in process simultaneously on adjacent or nearby lines unless these operations are separated physically or spatially;

2. [formerly paragraph 6:208-2] provide for an inspection of the facilities prior to use to assure that all drugs and previously used products and labeling materials have been removed;

3. [formerly paragraph 6:208-3] include the following labeling controls:

a. [formerly paragraph 6:208-3 (1)] the holding of labels and package labeling upon receipt pending review and proofing against an approved final copy to assure that they are accurate regarding identity, and content before release to inventory;

b. [formerly paragraph 6:208-3 (2)] the maintenance and storage of each type of label and package labeling representing different products, strength, dosage forms or quantity of contents in such a manner as to prevent mix-ups and provide identification;

c. [formerly paragraph 6:208-3 (3)] a system for assuring that only current labels and package labeling are retained and that stocks of obsolete package labeling are destroyed;

d. [formerly paragraph 6:208-3 (4)] restriction of access to labels and package labeling to authorized personnel;

e. [formerly paragraph 6:208-3 (5)] avoidance of gang printing of cut labels, cartons or inserts when the labels, cartons or inserts are for different products or different strengths of the same products or are of the same size and have identical or similar format and/or color schemes. If gang printing is employed, packaging and labeling operation shall provide for added control procedures. These added controls should consider sheet layout, stacking, cutting and handling during and after printing;

4. [formerly paragraph 6:208-4] provide for strict control of the package labeling issued for use with the drug. Such issue shall be carefully checked by a competent individual for identity and conformity to the labeling specified in the batch production. Said individual shall reconcile any discrepancy between the quantity of the drug finished and the quantities of labels issued;

5. [formerly paragraph 6:208-5] provide for examination or laboratory testing of samples of finished product after packaging and labeling to safeguard against any errors in the finished operation and to prevent distribution of any batch until all tests have been met.

La. Admin. Code tit. 51, § VI-1531

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1255 (June 2002).

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.