FDA 21 CFR 211: Docket FDA-1997-N-0518, 3/12

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Approved docket FDA-1997-N-0518 was published on March 20, 2012.

This docket changes 21 CFR 211.122(g) to limit the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, and multi-unit cartons containing immediate containers not packaged in individual unit cartons.ﾠThis change went into effect on March 20, 2013.

Docket FDA-1997-N-0518 also adds sub-point (4) to 21 CFR 211.122(g) This docket changed 21 CFR 211 to allow use of automated techniques to physically prevent incorrect labeling from being processed when cut labeling is used..ﾠThis change went into effect on April 19, 2012.

With this change, manufacturers are now permitted to use a broader range of error prevention and labeling control techniques than previously permitted.