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§ 116.3 - Label records.

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

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

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

Label number and date assigned; and

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

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

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§ 116.3 - Label records.