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.
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.
Apr 30, 2002
Recommended
Machinery Basics
Annual Outlook Report: Workforce
Hiring remains a major challenge in packaging, with 78% struggling to fill unskilled roles and 84% lacking experienced workers. As automation grows, companies must rethink hiring and training. Download the full report for key insights.
Download Now
Annual Outlook Report: Automation & Robotics
What's in store for CPGs in 2025 and beyond? Packaging World editors explore the survey responses from 118 brand owners, CPG, and FMCG Packaging World readers for its new Annual Outlook Report.
Download
