Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs; Republication

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The Food and Drug Administration (FDA) is proposing to amend its regulations to require the labels of prescription drugs to bear the statement "Rx only" instead of the statement "Caution: Federal law prohibits dispensing without prescription" and to remove the requirement that certain habit-forming drugs bear the statement "Warning--May be habit forming." The agency is also proposing to add a new section to the regulations to make clear that these habit-forming drugs must be dispensed by prescription only. The agency is taking this action to implement changes made by the Food and Drug Administration Modernization Act of 1997 (FDAMA).