FDA Issues Guidance On OTC Drug Labeling Rules

Law360, New York (January 5, 2009, 12:00 AM EST) -- The U.S. Food and Drug Administration has issued guidelines to help manufacturers, packers and distributors of over-the-counter drug products comply with the agency's standardized labeling content and format requirements.

The guidance addresses frequently asked questions regarding the FDA's requirement that manufacturers present OTC drug information in a prescribed order and format, the Department of Health and Human Services announced Friday.

Established in March 1999, the regulation is intended to standardize labeling for all OTC drug products so consumers can easily read and understand their labels and...
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