Over-the-Counter Human Drugs; Proposed Labeling Requirements; Extension of Comment Period

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The Food and Drug Administration (FDA) is extending to October 6, 1997, the period for comments for the notice of proposed rulemaking on over-the-counter (OTC) labeling requirements that was published in the Federal Register of February 27, 1997 (62 FR 9024). The document proposed to establish a standardized format for the labeling of OTC drug products. The document supersedes the agency's proposed rule regarding the use of interchangeable terms, published in the Federal Register of March 4, 1996 (61 FR 8460), and responds to the comments that were submitted to FDA as a result of that proposal (Docket No. 92N-454A). The document also proposes to preempt State and local rules that establish different or additional format or content requirements than those in the proposed rule. FDA is extending the comment period of the proposed rule in response to two manufacturers' associations requests to extend the period for comments to allow interested persons adequate time to assess and respond to the proposal. Elsewhere in this issue of the Federal Register the agency is also announcing that the Nonprescription Drugs Advisory Committee will meet to discuss proposed labeling requirements for O