Over-the-Counter Human Drugs; Labeling Requirements; Delay of Implementation Date

The Food and Drug Administration (FDA) is providing a delay of the implementation date 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 OTC sunscreen drug products. This document postpones the implementation date of the drug facts rule as it applies to OTC sunscreen drug products pending the outcome of the future rulemaking.