OTC labeling

April 16, 2002, was the compliance date for OTC drug packages to bear the standardized format and content requirements established by FDA on March 17, 1999.

Products with sales of less than $25ꯠ have an additional year to comply. In studying the matter, the Food and Drug Administration said it learned that OTC drug manufacturers routinely redesign their product labels as part of their customary business practices, so the majority of manufacturers will be able to comply with the new format regulations with no additional paperwork or economic burdens. The agency estimated that approximately 32% of the drugs would need to be relabeled ahead of their customary redesign schedule. Manufacturers holding new drug applications and abbreviated new drug applications also may need to change their labeling. In all cases, it will be a one-time burden, according to FDA.

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