FDA Rule Tweak Touts Use of Automated Systems for Cut Labeling

The increased use of automated control systems for cut labeling can reduce the risk of human error during the packaging process, the FDA says in a regulatory tweak that allows drugmakers greater flexibility in meeting manufacturing requirements.

The agency is permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling of products by labeling and packaging equipment when cut labeling is used, a recent notice in the Federal Register states.

Allowing for additional automated controls will give manufacturers “the widest possible latitude in selecting appropriate labeling control technologies,” the agency said in amending its 1993 final rule implementing the packaging and labeling provisions of its manufacturing regulations.

Human error or not, labeling remains one of the most intensely scrutinized aspects in agency inspections.

Worry not, every October an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place Oct. 16-17, 2012, in Washington, D.C.