Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates

The Food and Drug Administration (FDA) is providing a partial delay of the compliance dates for certain products subject to its final rule that established standardized format and content requirements for the labeling of over-the-counter (OTC) drug products (Drug Facts Rule). That final rule requires all OTC drug products to comply with new format and labeling requirements within prescribed implementation periods. The agency intends in a future issue of the Federal Register to propose an amendment to the Drug Facts Rule to modify the labeling requirements for "convenience-size" OTC drug products. This final rule postpones the compliance dates under the Drug Facts Rule for certain convenience-size OTC drug products pending the outcome of the future rulemaking.