The FDA has been reviewing problems with incorrectly-labelled medicines and associated product recalls since 1997. Special attention here has been paid to labels created using the gang printing or cut labelling methods. The first type involves labels whose printed content is different but which are created on one sheet. These remain prohibited if the labels do not differ in terms of their shape, size or colour. The second type is collated into stacks of labels per product item after being printed in bulk together. Here, the danger of intermixing is particularly high. Since 1993, a special control provision (21 CFR 122(g)) has been applied to such stacks of pre-printed labels. If this type of labels is used, then one of three predefined control procedures must be applied: (1) dedicated packaging and labelling lines must be used for separate products or product strengths; (2) appropriate electronic or electromechanical equipment must be used to conduct a 100 % examination for correct labeling during or after completion of finishing operations; or (3) if manual labelling is used, then a visual check that the correct label was applied must be performed in 100% of cases, followed by verification by a second person. The US pharmaceuticals industry has managed to achieve a relaxation of the rules here. A fourth option has been added to the control provisions: (4) manufacturers may deploy any form of automated control that can physically exclude incorrect labelling, such as e.g. verification of the correct label size or shape. The extent to which this differs from the previous control option (2) remains to be seen. The application scope requiring mandatory application of 122(g) has also been reduced. The special inspection controls are now mandatory only for labels intended for consumers, i.e. immediate container labels, individual unit pack labels and multi-unit pack labels for immediate containers not packaged in individual unit packs.
The final wording is valid from 20 March 2013, with the exception of the amendment to Article 211.122(g)(4), which entered into force on 19 April 2012.
A detailed summary can be found in the Federal Register, where CFR amendments are published before they enter into force.
Dr. Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the European Compliance Academy (ECA))