The US FDA will today publish a final rule to change cGMP labelling controls, 15 years after proposing the revision.
US Food and Drug Administration (FDA) efforts to change the requirements began in the early 1990s after labelling mix ups, the first of which was in 1987, led to drug recalls. After a back-and-forth with trade groups, which opposed changes the FDA made in 1993, a proposed rule was published in 1997.
Now, 15 years later, the FDA is to publish the final rule in the Federal Register today. “The final rule adopts the proposed codified without change”, the FDA wrote , and narrows the scope of revisions it made to cGMPs (current good manufacturing practice) for cut and gang-printed labelling in 1993.
In gang-printed labelling stickers for different products are done on the same sheet. This process was linked to labelling mix ups. Cut labelling places stickers in separate stacks before being shipped and applied to products. Stacks of similar size, shape, and colour were mixed, again leading to recalls.
Changes made by the FDA in 1993 asked companies to use control procedures, such as packaging lines dedicated to each product, when they used cut labelling. However, in the face of trade group opposition, the need for control procedures was limited to consumer-facing labels.
“This amendment is intended to protect consumers from labelling errors that are more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labelling unlikely to reach or adversely affect consumers”, the FDA wrote.
Another change to the 1993 rule is the addition of a fourth control procedure. The change allows manufacturers to use “any automated technique… that physically prevents incorrect labelling”. By making the change the FDA hopes to give the “widest possible latitude” in control choice.
The final rule will take effect on March 20 2013.