OTC label rule effective date
This article was originally published in The Tan Sheet
Executive Summary
May 16 is effective date of OTC labeling final rule, not April 16, FDA states in correction notice published April 15. Under the rule's implementation plan, the new labeling requirements must be in place two years from the effective date for many products, with an extra year provided for products with annual sales of less than $25,000 ("The Tan Sheet" March 15, p. 8)