Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004349:Drug Packaging / Q000331:legislation & jurisprudence; D006801:Humans; D008508:Medication Errors; D014481:United States; D014486:United States Food and Drug Administration