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Frequently Asked Questions

What is gang-printed drug labeling?

a) Gang-printed labeling is a sheet of labeling that contains ¨ Different drug products, strengths, or net contents of same drug b) Gang-printed sheets are prohibited unless well differentiated ¨ By size, shape, and color

How did FDA regulate gang-printed and cut labels?

To reduce the frequency and likelihood of such mislabeling, FDA, in the Federal Register of August 3, 1993 (58 FR 41348), amended the packaging and labeling control provisions of the CGMP regulations in part 211 ( 21 CFR part 211) to provide specific conditions for the use of all gang-printed and cut labeling.

What is the difference between gang-printed and cut labels?

When labels are gang-printed, the labels for different drug products or different strengths for the same drug product are processed together, making them especially susceptible to mixups. Similarly, cut labeling is commonly placed in separate stacks before being transported to packaging and labeling lines for application to appropriate products.

What are the risks of gang printing?

Timing issues—gang printing customers normally need to be more patient with their client, since it takes more time and effort to coordinate all the jobs through the singer viewer. The U.S. Food and Drug Administration (FDA) warns to be aware of the potential of foreign packages, which may come from gang printing at the package supplier.

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