What is standardizing OTC labeling?
In the Federal Register of March 17, 1999 [PDF], FDA published a final regulation (21 CFR 201.66), establishing standardized content and format for the labeling of OTC drug products. Standardized labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug products safely and effectively. The labeling regulations in 21 CFR 201.66 cover all OTC drug and drug-cosmetic products, whether marketed under a 505(b)(1) application, a 505(b)(2) application, abbreviated new drug application ,or an OTC drug monograph.
In the Federal Register of March 17, 1999 (PDF – 1MB), FDA published a final regulation (21 CFR 201.66), establishing standardized content and format for the labeling of OTC drug products. Standardized labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug products safely and effectively. The labeling regulations in 21 CFR 201.66 cover all OTC drug and drug-cosmetic products, whether marketed under a 505(b)(1) application, a 505(b)(2) application, abbreviated new drug application ,or an OTC drug monograph.
