Business · 10/04/2000

FDA Proposes Changes to Prescription Drug Label Regulations

The Food and Drug Administration (FDA) is proposing to update its regulations to require prescription drug labels to display the statement 'only' instead of 'Caution: Federal law prohibits dispensing without prescription' and to remove the requirement for certain habit-forming drugs to display the statement 'Warning--May be habit forming.' The FDA aims to implement these changes, which were mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA), to clarify the dispensing requirements for these drugs.