§ 116.3 Label records.

(a) Each licensee and permittee shall maintain a list of all approved labels currently being used. Each label shall be identified as to:

(1) Name and product code number as it appears on the product license or permit for the product;

(2) Where applicable, the size of the package (doses, ml, cc, or units) on which the label shall be used;

(3) Label number and date assigned; and

(4) Name of licensee or subsidiary appearing on the label as the producer.

(b) All labels printed shall be accounted for and an inventory maintained.

Records shall include the disposition of such labels including those not used in labeling a product.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 27, 2001]