The US Food and Drug Administration last week 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 United States 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” often used by Congress.

The guidance describes 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 email 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 Dec. 22, 2007, and the labeling requirements are already in effect. FDA intends to “exercise enforcement discretion for the new labeling requirements until September 30, 2010.” Enforcement will begin immediately after this date.

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FDA Releases Draft Guidance for OTC Labeling (ePT article)