FDA issues final guidance on OTC drug labelling

Sep 04, 2009

The FDA has issued the final draft of its Guidance for Industry titled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.” The guidance is intended to help manufacturers, packers and distributors of such drug products comply with the new section 502(x) of the Federal Food, Drug, and Cosmetic Act.

Section 502(x) states that the label of an over-the-counter (OTC) drug marketed in the US without an approved application must include “a domestic address or domestic phone number through which the responsible person … may receive a report of a serious adverse event.” The guidance document clarifies the meaning of “domestic address” as the complete mailing address, so as not to be confused with the term “place of business” address often used by Congress.

The guidance describes the FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label. Several examples of such a statement are listed in the document. According to the guidance, the product label can include an e-mail address or website to which reports can be made, “provided that such email address or web site is in addition to the domestic phone number or domestic address ….”

Section 502(x) of the Act became effective on 22 December 2007, so the labeling requirements are already in effect. The FDA intends to “exercise enforcement discretion for the new labeling requirements until 30 September 2010,” with enforcement beginning immediately after this date.

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