Labeling controls
This article was originally published in The Tan Sheet
Executive Summary
FDA issues final rule in the Aug. 3 Federal Register on labeling controls for human and veterinary drugs in an effort to reduce the frequency of labeling problems. The final reg is essentially unchanged from a June 1989 proposal, and specifies conditions for use of gang-printed or cut labeling. The reg also exempts manufacturers that use automated 100% labeling inspection systems from current GMP labeling requirements, and requires that manufacturers identify filled drug containers that are set aside and not labeled until later in the production process.