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FDA Extends Over-the-Counter (OTC) Drug Labeling Compliance Date

Date: May 18, 2000


The Food and Drug Administration (FDA) has extended the compliance date for implementation of new format-and-content labeling requirements for over-the-counter (OTC) drug products. The new regulations establish a standardized format (e.g., information layout, minimum type size) designed to make OTC drugs' labels more consistent. In addition, new standard content requirements are intended to improve consumers' ability to understand the proper uses, directions, and risks of OTC medicines. The regulations were published in the Federal Register last year and became "effective" on May 16, 1999. 64 Fed. Reg. 13254 (March 17, 1999) (revising 21 C.F.R. ยง 201.66). However, the Agency established an implementation schedule that generally allowed two years (i.e., until May 16, 2001) for manufacturers to modify their labeling (with a longer time period allowed under certain circumstances).

On October 1, 1999, and October 22, 1999, two trade associations filed Citizen Petitions requesting that FDA extend the deadline for compliance with the new labeling requirements by an additional two years (i.e., until May 16, 2003). The groups argued that the extension was needed to allow OTC drug manufacturers enough time to implement the necessary labeling revisions, as well as to resolve numerous outstanding issues. After considering the Petitions, FDA announced it was extending the primary implementation date by one year, to May 16, 2002. (with a corresponding extension for other circumstances) (FDA responses to Citizen Petitions in Docket Nos. 99P-4617 and 98N-0337 (both responses dated February 4, 2000)). The Agency intends to announce this extension in an upcoming notice in the Federal Register, but has not yet done so. Regardless of the compliance deadlines, however, FDA "strongly encourages all manufacturers, distributors, and packers of OTC drug products to voluntarily implement the new content and format requirements as soon as possible, particularly when existing labeling is exhausted and relabeling would occur in the normal course of business." 64 Fed. Reg. at 13274.

For further information about FDA's OTC drug labeling requirements, or for a copy of FDA's letters responding to the Citizen Petitions, please contact: Frederick A. Stearns (202-434-4288) stearns@khlaw.com