Zdrowie i gospodarka · 27/02/1997

Over-The-Counter Human Drugs; Proposed Labeling Requirements

The Food and Drug Administration (FDA) is proposing to establish a standardized format for the labeling of over-the-counter (OTC) drug products. FDA has determined that because the design and format of labeling information varies considerably among OTC drug products, consumers often have difficulty reading and understanding the information presented on OTC drug product labeling. The proposal 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. This document supersedes the agency's proposed rule regarding the use of interchangeable terms, published in the Federal Register of March 4, 1996 (hereinafter referred to as the March 1996 proposal), and responds to the comments that were submitted to FDA as a result of that proposal (Docket No. 92N-454A). Accordingly, this document formally withdraws the March 1996 proposal. Finally, this proposal would preempt State and local rules that establish different or additional format or content requirements.