OVER-THE-COUNTER (OTC) DRUGS

KKB advises clients on regulation and marketing of OTC drugs, including:

		Drugs subject to FDA’s OTC monograph system
		Drugs switched from prescription status and/or marketed under NDAs
		Drugs subject to List 1 chemical status
		Current Good Manufacturing Practices

As with prescription drugs, we regularly negotiate the legal status of products with FDA, including the filing of petitions and comments in rulemaking proceedings. We provide review of label content and format and handle policy issues relating to labeling. In the area of OTC drug advertising, we provide advice on compliance with FTC and related requirements, and handle advertising disputes in various forums, including the FTC, State attorneys general, Lanham Act litigation, and industry self-regulation cases before the National Advertising Division of the Council of Better Business Bureaus, Inc. (NAD).