OTC labeling reg
This article was originally published in The Tan Sheet
Executive Summary
FDA draft guidance on exemption/deferral applications based on insufficient labeling space is "meaningless in a practical sense" because "if it were possible or practicable to reconfigure or re-engineer the packaging to meet the final regulation, no exemption would be necessary," CHPA says in Feb. 20 comments. In a draft guidance published in December, FDA reiterates it will not routinely grant exemptions for products that claim to be too small to satisfy the final labeling reg requirements, but will consider deferral requests to allow packaging changes (1"The Tan Sheet" Jan. 1, p. 10). In separate comments, CTFA calls "vague and impracticable" FDA's proposed response times of 30-60 days for "straightforward requests" for exemption or deferral and 120-180 days for "new or complex issues"