Revised Guidance for Industry on Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997Elimination of Certain Labeling Requirements

概要

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997-- Elimination of Certain Labeling Requirements.'' Section 126 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act) amends the Federal Food, Drug, and Cosmetic Act (the act) to require, at a minimum, that prior to dispensing, the label of prescription products contain the symbol ``Rx only'' instead of the ``Caution: Federal law prohibits dispensing without prescription'' statement. In addition, the requirement that the labels of certain habit-forming drugs bear the statement ``Warning-May be habit forming'' has been repealed. The revised guidance changes the implementation schedule provided in the original guidance dated February 1998, and answers certain questions concerning implementation of these amendments.