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

Resumen

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).