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Statement of Need: Currently, the design, format, and placement of required labeling information varies considerably among OTC products. As a result, consumers often have difficulty finding, reading, and understanding this labeling information. Modifying and simplifying the manner in which the information is presented can improve the legibility and understandability of OTC drug product labeling. Therefore, this final rule will establish a standardized format for the labeling of all marketed OTC drug products. This action is intended to enable consumers to better read and understand OTC drug product labeling and to apply this information to the safe and effective use of OTC drug products.

Summary of the Legal Basis: FDA's legal authority to modify and simplify the manner in which certain information is presented in OTC drug product labeling derives from sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act). Regulating the order, appearance, and format of OTC drug product labeling is consistent with the agency's authority to ensure that drug labeling convey all material information to the consumer (21 USC 321(n) and 352(a)), and that the labeling communicates this information in a manner that is "likely to be read and understood by the ordinary individual under customary conditions of purchase and use." (21 USC 352(c)). Regulating the content of OTC drug product labeling is consistent with FDA's authority to ensure that the products are safe and effective for use (sections 201(n) and (p), 502, and 505 of the act).

Alternatives: FDA considered several alternatives. First, the agency considered but rejected a voluntary labeling scheme, as previous industry efforts have been unsuccessful in achieving both a uniform format and an acceptable minimum print size for a majority of the products on the market. Second, the agency considered but rejected revising all OTC monographs on an individual basis because this approach would not achieve a standardized labeling format for a majority of the marketed products in a timely manner. Third, the agency considered alternative implementation periods but chose the option proposed because it believed that the chosen approach provides significant reduction in cost while meeting the agency objective of achieving a standardized labeling format for a majority of the products in a timely manner.

Anticipated Costs and Benefits: The final rule is expected to cost a total of $14 million when implemented. This cost includes a 1-year extension for implementation time of individual OTC drug products having sales of less than $25,000 per year. ^PIn general, the rule will benefit consumers by allowing them to make more appropriate choices for self-treatment, and to reduce trial and error approaches to self-medication. Consequently, this could lead to decreased overall health care costs resulting from reduced visits to the doctor or hospital for treatment. Additionally, the easy to read, standardized format will directly benefit consumers by helping ensure the safe and effective use of the product.

Risks: None.